Although Not to Forecast Level, MDSO’s CTMS Sales Will...

July 10, 2014 Companies: IBM, MDSO, MRGE, ORCL, QCOM, PRXL

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1 Ferry Building, Suite 255, San Francisco, CA 94111 | www.blueshiftideas.com

Although Not to Forecast Level, MDSO’s CTMS Sales Will Grow This Year

REPORT David Franklin, [email protected]

Summary of Findings

As Blueshift Research found in its Dec. 13, 2013, report, Medidata

Solutions Inc. (MDSO) is secure in leading the CTMS industry.

Eighteen of 23 sources said Medidata will continue to grow its

sales this year, including eight sources who believe Medidata can

achieve its 20% to 25% growth projection. One source said an

industry merger or one or two large contracts alone could generate

significant sales for the company.

Medidata and Oracle Corp. (ORCL) dominate the large pharma

market. However, three sources said Oracle may be losing share.

Medidata’s strengths are its reputation, longevity, salespeople,

products and programming. Challenges include a saturated high-

end market and a high price that limits down-market success (both

issues identified by Blueshift in December), complicated products,

and inconsistent customer support and product integration.

CTMS industry growth is being driven by pharma and CRO M&A,

more clinical trials, cloud-based and collaborative solutions, and

pharma’s migration from in-house software to standard solutions.

CTMS trends include big data acquisition, data collection

management, risk management, regulatory mandates, health

record integration and mobile apps for trial patients.

CTMS competition is abundant as 20 companies were discussed,

including BioClinica Inc., OmniComm Systems Inc., Parexel

International Corp. (PRXL), Merge Healthcare Inc. (MRGE), Datatrak

International Inc., MedNet Solutions Inc. and OpenClinica LLC.

MDSO 2014

Sales

MDSO to

Achieve 20%–

25% Growth

CTMS Market

MDSO Customers and

Partners

Medical R&D, IT and

CRO Professionals

Competitors’ Customers

Competitors

Industry Specialists

Research Question:

Can Medidata capitalize on a stronger sales pipeline to reach its projected growth of

20% to 25% despite challenges from innovative competitors?

Silo Summaries

1) Medidata Customers and Partners Four of these six sources expect Medidata to continue

to grow its sales this year, and another source said the

company could even achieve its growth forecast of 20%

to 25% if it offers “best-of-breed” products. Along with

Oracle, Medidata leads in servicing large pharma.

2) Medical R&D, IT and CRO Professionals Four of these five sources expect Medidata to

experience sales growth throughout this year, while the

remaining source expects its sales to be steady. A

growth rate of 20% to 25% is unlikely. Medidata is

considered too robust for most applications in the

midtier market.

3) Medidata Competitors’ Customers Three of these four sources expect Medidata to

experience continued sales growth this year. The

remaining source was uncertain about its growth

opportunities, but noted a need for new software in big

pharma. The three sources who expect Medidata to

grow believe a rate of 20% to 25% could be achieved

through mergers or by securing one or two large clients,

but they added that this kind of expansion takes time.

All four sources expect the clinical trial market to

broaden although one source noted that growth in the

university research setting will be slow.

4) Medidata Competitors Two of these four sources said Medidata’s growth

would not continue this year. However, two others said

its sales could increase further, and one said reaching

the 20% to 25% forecast even was possible; these two

sources credited Medidata’s strong reputation and

longevity, the current high demand for cloud-based

solutions, and the lack of strong competitors. The

detractors said Medidata would be challenged by its

high pricing, its lack of responsiveness to customers

and the saturated big pharma segment.

5) Industry Specialists These four sources expect Medidata’s sales growth to

continue this year, thanks to capturing market share

from Oracle, the pharma M&A trends, and CROs and

pharma abandoning in-house clinical trial software.

However, achieving 20% to 25% growth in a saturated

market will be a challenge. Also, Medidata will have

some difficulty expanding into the smaller markets, but

its modular products may be of interest if offered as a

pay-as-you-go model.

mailto:[email protected]

http://blueshiftideas.com/reports/121303MedidataWillDominateLargePharmaButWillSeeLittleMovementDownMarket.pdf

http://www.mdsol.com/

http://www.mdsol.com/

http://en.wikipedia.org/wiki/Clinical_trial_management_system

http://www.oracle.com/index.html

http://en.wikipedia.org/wiki/Contract_research_organization

http://www.bioclinica.com/

http://www.omnicomm.com/

http://www.parexel.com/

http://www.parexel.com/

http://www.merge.com/Solutions/Clinical-Trials.aspx

http://www.datatrak.com/

http://www.datatrak.com/

http://www.mednetstudy.com/products/

https://www.openclinica.com/about


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Medidata Solutions Inc.: CTMS Market

Background

Medidata Solutions missed its first-quarter earnings and revenue expectations, but management remained optimistic about

the company’s opportunities as it saw 21% revenue growth year to year. Also, its customer base grew to 420, and 52% of

customers adopted multiple products—an 11 percentage point increase from a year ago. Its sales pipeline contains twice the

potential of a year ago, and interest in its products has increased. Medidata is focused on matching customer CIOs’ biggest

priorities through its cloud-based platform in life sciences, a massive set of clinical data and analytics, and a mobile solution

called Medidata Patient Cloud. As a result, management reiterated its long-term revenue growth target of 20% to 25%.

Blueshift’s Dec. 13, 2013, report revealed that Medidata was a clinical trial management system (CTMS) leader with a

primary strength in serving large pharma. However, sources said CTMS demand from large pharma could be curtailed by

some product saturation, and added that growth would come from the small to midtier clinical trial market. Serving this

market would be a challenge for Medidata because of its nontransparent high pricing, older software design, and competition

from innovative industry players.

Many competitors are ramping up their efforts to gain share in the CTMS market, which expected to grow 14.1% in 2014 and

see a compound annual growth rate of 13.6% through 2019. OmniComm recently landed deals with Seoul National University

Hospital, and is conducting clinical studies with a leading specialty pharma company as well as the Surrey Clinical Research

Centre. BioClinica holds contracts with two of the top 10 pharma companies. Meanwhile, Qualcomm built an app that allows

mobile devices to serve as gateways to patient medical information.

Current Research In this next study, Blueshift Research assessed Medidata’s sales pipeline and its ability to meet its sales growth forecast of

20% to 25% despite stiff competition. We employed our pattern mining approach to establish six independent silos,

comprising 23 primary sources (including five repeat sources) and five secondary sources focused on the CTMS industry:

1) Medidata customers and partners (6)

2) Medical R&D, IT and CRO professionals (5)

3) Medidata competitors’ customers (4)

4) Medidata competitors (4)

5) Industry specialists (4)

6) Secondary sources (5)

Next Steps

Blueshift Research will monitor the clinical trial software industry to determine contract and share wins and losses, including

in the small and midsize markets. We also will research Medidata’s sales outside the United States. Finally, we will gauge

Oracle’s market share in light of some sources’ reports of losses for the company.

Silos

1) Medidata Customers and Partners Four of these six sources expect Medidata to continue to grow its sales this year, and another source said the company could

even achieve its growth forecast of 20% to 25% if it offers “best-of-breed” products. Along with Oracle, Medidata leads in

servicing large pharma. Medidata has an opportunity to infiltrate midsized pharma and CROs, but for now OpenClinica,

BioClinica and Clinovo’s ClinCapture serve the midrange and small pharma markets. Medidata’s strengths include a strong

sales staff, a solid and broad product offering and substantial programming resources. Its challenges include its high prices,

which could limit its down-market reach; it also offers inconsistent customer support and product integration. All six sources

http://seekingalpha.com/article/2154373-medidata-solutions-ceo-discusses-q1-2014-results-earnings-call-transcript

http://www.mdsol.com/products/patientcloud.htm

http://blueshiftideas.com/reports/121303MedidataWillDominateLargePharmaButWillSeeLittleMovementDownMarket.pdf

http://www.prweb.com/releases/2014/01/prweb11536955.htm

http://www.businesswire.com/news/home/20140422006323/en/Research-Markets-Clinical-Trial-Management-System-CTMS#.U3zr8oWgWZI

http://www.omnicomm.com/press/2014_04_03__Seoul_National_University_Hospital_Signs_Five_Year_Agreement_with_OmniComm_Systems_TrialOne.html

http://www.omnicomm.com/press/2014_04_03__Seoul_National_University_Hospital_Signs_Five_Year_Agreement_with_OmniComm_Systems_TrialOne.html

http://www.omnicomm.com/press/2014_04_07__Leading_Specialty_Pharmaceutical_Company_Selects_TrialMaster_to%20Support_Novel_Medical_Research.html

http://www.omnicomm.com/press/2014_04_14__Surrey_Clinical_Research_Centre_Signs_a_Five_Year_Agreement_for_OmniComm_Systems_Promasys.html

http://www.omnicomm.com/press/2014_04_14__Surrey_Clinical_Research_Centre_Signs_a_Five_Year_Agreement_for_OmniComm_Systems_Promasys.html

http://www.fiercecro.com/press-releases/bioclinica-inks-30-million-eclinical-contracts-two-top-10-pharma-companies

http://www.fool.com/investing/general/2014/05/19/how-qualcomm-plans-to-change-the-global-face-of-he.aspx


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expect continued sales growth in CTMS and related industry products, driven from outside the saturated electronic data

collection (EDC) market and by fully integrated cloud-based trial management platforms with complete data management and

analytics capabilities. Emerging CTMS trends include a migration away from in-house software to standardized solutions,

greater regulatory requirements and wearable data collection devices.

KEY SILO FINDINGS Medidata Sales Pipeline

- 4 sources expect continued growth for Medidata but did not quantify.

- 1 other expects Medidata to achieve 20% to 25% growth.

- 1 did not comment.

- Medidata has added to its product offerings and is targeting midsize pharma.

- Medidata is considered too costly for small pharma.

CTMS Market Conditions

- All 6 expect growth in the clinical trial software market.

- Growth will come from products other than EDC, which is saturated.

- Pharma and CROs are moving away from in-house clinical trial software solutions.

Clinical Trial Software Competitive Landscape

- Large pharma is dominated by Medidata and Oracle.

- The small pharma market is highly competitive.

- Startup and small software companies typically find initial success in smaller pharma firms.

Trends

- Emerging trends include more regulatory requirements, wearable data collection devices and a migration away from

in-house software.

1. Manager of clinical data management for a West Coast biopharmaceutical company; repeat source

Medidata’s growth forecast of 20% to 25% could be achieved through adequately funded and managed R&D efforts and

best-of-breed products. It will continue to sell to large companies, but also now is targeting the more numerous midsize

companies. Its software may be too expensive and complicated for smaller companies. Medidata’s strengths include

solid products and large programming resources. Its weaknesses include inconsistent support, high cost and uneven

product integration.

Medidata Sales Pipeline

“[Medidata growth of 20% to 25% is] probably achievable. They seem to

have a strong sales team. They will need to make sure their R&D effort is

well managed and adequately funded, so they’ll have the best-of-breed

products.”

“I don’t know about Medidata’s pipeline. I have heard that [Medidata has]

about 50% of the global market for EDC software, but I don’t know anyone

who’s using their CTMS software. Not sure it’s best-of-breed. If it’s true they

have 50% of the EDC market, then I’m not sure how much more they can

grow that line of their business. Since they have a much smaller CTMS

footprint, there’s probably much more room for growth on that end.”

“Medidata will continue selling to large companies. Midsized, yes. This is

probably their biggest target since there are more companies, and I think

they have less penetration already so more room for growth. Small pharma,

I’m not so sure, unless they provide turnkey entry-level solutions at a

competitive cost. Software needs to be streamlined and easy to implement

for the smaller companies, and flexibility and customizability are less important.”

“Medidata’s strengths include solid products and a large pool of programming resources, which makes it easier for

customers. We know we can find resources with Medidata experience, while all other vendors require training.

Medidata is the industry standard.”

If it’s true they have 50% of the

EDC market, then I’m not sure

how much more they can grow

that line of their business.

Since they have a much

smaller CTMS footprint, there’s

probably much more room for

growth on that end.

Manager of Clinical Data Management

West Coast Biopharmaceutical Co.

http://www.forbes.com/sites/parmyolson/2014/06/19/wearable-tech-health-insurance/


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“It is a mixed bag on support provided by Medidata. For example, if we hire them to do study builds, sometimes we

get good service; other times it’s slow and poor quality. The cost is expensive, especially for support—$200 per hour

for all services. Integrations of their various products are not always smooth. It is kind of a motley collection of

different tools they’ve acquired, not a smoothly integrated single-platform enterprise solution.”


“There is still a demand for clinical software, with a wide range of pricing. Medidata [Rave EDC platform] is at the

upper end of the range, especially for support. Akaza [Research, now OpenClinica] and Clinovo [ClinCapture] are at

the lower end, with open-source solutions; they are inexpensive to acquire but hard to implement.”

“[The market is competitive] especially in the lower levels. A lot of companies are trying to get into the market, but in

general their offerings have limited functionality, performance, or support compared to Medidata.”

“Large companies [are more likely to buy CTMS]. CTMS systems vary widely in capabilities, that is, feature set. They

also take a lot of configuration, especially the more full-featured ones. This makes them expensive to implement,

requiring in-house IT resources or consultants. Smaller companies tend to rely on spreadsheets and manually

tracking their studies.”


“I have not been tracking CTMS vendors lately. One smaller, much less expensive but less full-featured vendor is

BioClinica. Their product is OnPoint.”

Trends

“There’s a huge unmet need for a well-designed, nicely integrated system that addresses a large number of small

needs covering a wide range of stakeholders. For example, [there is need for] an investigator site portal designed

explicitly to their management of the study; good support for clinical monitors including SDV [source data

verification] worksheets that integrate with EDC and with CTMS; study operational for the clinical operations team;

and good metrics for both clinical operations and upper management. From what I’ve seen of existing systems …

each system addresses some aspects of the total picture, but nobody gets it all.”

2. Clinical programmer at a West Coast biopharmaceutical company

Medidata is pushing more products and entering competitors’ domains, all of which may indicate sales growth. The

company will continue to sell to large pharmas and CROs and is starting to target midsize companies.


“Medidata is pushing a lot more products to our company, so they may have more to push. But we aren’t biting as

much. We are content where we are, and we need some more space.”

“We heard that Medidata is adding a lot more bells and whistles to their software than needed. Few people know

how to use everything. But we have lots of needs and are growing, so the additions may all be worth it if it’s not too

expensive.”

“Medidata will continue to sell to large pharmas, even to those who do some outsourcing. Medidata is also trying to

sell to the large CROs, and they will continue to do this.”

“Midsize companies buy software, and this is a good area to target.

Medidata is moving toward medium-sized companies because they see

them as being attractive, and they could be successful. For the smaller

companies, it is a tossup.”


“We are now bringing our trial management back in-house due to the quality

of CROs and the timeliness. At our company, we now have 75% on-site.

Other companies are doing the same as well.”

“The large pharmas use CROs. They can afford to buy software and also

outsource.”


“Oracle is the biggest competitor although Medidata’s programs are

complete.”

“Medidata is not always responsive to customer concerns, and this can be a

problem. We hear that Oracle does a better job at this. Medidata’s programs

Midsize companies buy

software, and this is a good

area to target. Medidata is

moving toward medium-sized

companies because they see

them as being attractive, and

they could be successful. For

the smaller companies, it is a

tossup.

Clinical Programmer

West Coast Biopharmaceutical Co.

http://www.mdsol.com/products/rave/overview

https://community.openclinica.com/content/akaza-research-releases-openclinica-beta-software-professional-open-source-solution-academic

http://www.bioclinica.com/eclinical/onpoint-ctms


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are also more time-consuming to set up.”

“There has been talk here of dropping Medidata and picking up Oracle. Companies change software brands, but

Medidata will need to offer better customer service to not lose contracts.”

Trends

N/A

3. Business manager and consultant to CROs and pharma, based in Europe; repeat source

This source, who builds on the Medidata systems for clients, sees increased client interest in mobile technology and in

using one vendor like Medidata for the entire technology landscape. Still, this conservative industry takes its time to

implement new ideas.


N/A


“The large companies in clinical trial management, Medidata and Oracle, the growth isn’t coming from the pure EDC

market anymore; growth is coming from integration with other services and systems, especially cloud data storage

and data analytics.”

“Using the cloud, doing big data analysis, doing clinical data warehousing: These are the areas were the technology

is rapidly expanding.”

“Years ago customers would have a Medidata EDC system, and then it was connected to dedicated backend

systems probably from other vendors, but now this seems to be combined now from vendors like Medidata and other

big ones. They’re really tried to serve the full landscape of systems, including clinical data warehousing.”

“For several years, CROs have been moving away from their own systems

and toward the major vendors like Medidata, and that trend is continuing as

we see more collaboration in the industry. Clearly, the same platform

makes collaboration far easier. Big pharma is using CROs more and other

vendors and requiring that they all work on the same platform.”

“More requirements from the regulatory authorities are also driving the

move to major platforms, and over the years it became obvious that it’s not

really feasible for smaller CROs to run their own systems.”


“Competition is not growing in this market. Medidata still has the largest

market share in Europe.”

Trends

“Medidata is focusing more on daily measurement of body signals reported

via mobile devices, so not really focused on clinical research. It seems that

they are looking toward having a broader landscape of services and

systems.”

“Companies are definitely starting to get interested in the wearables and

getting data from healthy people. There are initiatives going on surrounding using that data for finding clinical trial

subjects, but there are a lot of regulatory boundaries that have yet to be worked out.”

“This is such a conservative industry that although we’re hearing a lot of new ideas, we haven’t seen much new

implemented.”

4. Data project manager at an East Coast biopharmaceutical company

This source could not address the growth of Medidata’s pipeline or sales, but said end users like the company’s software.

Medidata will continue to sell to large and midsize pharma but may be too expensive for smaller companies. Medidata

and Oracle compete with many other small-name companies. Many companies now outsource, but doing so depends on

the length and complication of trials.

The large companies in clinical

trial management, Medidata

and Oracle, the growth isn’t

coming from the pure EDC

market anymore; growth is

coming from integration with

other services and systems,

especially cloud data storage

and data analytics.

Business Manager & Consultant

CROs & Pharma, Europe


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“Companies of all sizes use Medidata. They will continue to sell to large

pharmaceutical companies and midsize companies. Smaller companies

may have a harder time paying the Medidata prices.”

“Users like Medidata, and end users are driving its use. The investigators

say it is more of an exposed product.”

“We are working the kinks out of Rave right now. We need to make little

tweaks to make this happen. Rave is structurally more difficult. When you

make a migration or change, you need to take the whole system down.”

“Once you set up a program correctly, get it all done in the beginning with

all the FDA protocol, and you don’t need to change the protocol or made

amendments, you are good to go forever. It is hard when you start and then

need to change.”


“Companies change software all the time, and they often work in several different programs. I’m new to this

company, and we are just starting to use Medidata Rave.”

“Many companies outsource. I’m not sure why we aren’t sourcing. We may have all the parts we need here. Oncology

is more complicated, and we have a lot of Phase I studies, which are short, only six weeks long. It may be more

efficient to do the work in-house.”


“Oracle is one of the biggest names out there. After Medidata and Oracle, they are many other smaller companies.”

Trends

“Everyone wants real-time, and they want it to be done quickly.”

5. Clinical research scientist at a large Midwest university medical center

Medidata software works well for this research group, and the source said the company should grow if other researchers

have the same positive experience. The university hospital uses Oracle software and occasionally has problems with it.


“It is an interesting statement that [Medidata’s sales will grow 20% to 25% this year], but I can neither disclaim nor

confirm it. I have no problems with their software, and if other people do not, [the company] should grow.”

“Medidata is commonly used to capture patient information and data. Their data capture has a good interface.”

“We let Medidata know our protocol, what we want the software to do. This has worked well and is very helpful for

the end user.”


N/A


“The hospital uses Oracle software. They are a big Medidata competitor. If there is a problem with it, we hear about it

in a meeting.”

Trends

N/A

6. Clinical research coordinator at a research center in Florida

This center frequently uses Medidata software; if other centers or companies are doing the same, then the company

must be growing. The source could not address the size of Medidata’s pipeline, but said its products are user-friendly and

meet clients’ needs. She also uses other software brands but said the company names do not stand out like Medidata.


Companies of all sizes use

Medidata. They will continue to

sell to large pharmaceutical

companies and midsize

companies. Smaller companies

may have a harder time paying

the Medidata prices.

Data Project Manager

East Coast Biopharmaceutical Co.


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“I’m not sure about the company’s growth. I couldn’t answer this with confidence. But I can say that we use

Medidata frequently, for many studies. I would say their software is in high demand if other centers and companies

use it as frequently as we do.”

“The Medidata software is sufficient for us. Rave meets our needs. It is easy

to use. It all depends on the detail of the study, but it appears to be user-

friendly.”


N/A


“We use Medidata most frequently, but we also use other brands. I honestly

couldn’t tell you the names. We just follow the link and enter the data. The

names don’t stand out.”

Trends

N/A

2) Medical R&D, IT and CRO Professionals Four of these five sources expect Medidata to experience sales growth throughout this year, while the remaining source

expects its sales to be steady. A growth rate of 20% to 25% is unlikely, but opportunities do exist based on mergers and

acquisitions in pharma and CROs, the management of big data, collaborative software tools, wearable and mobile devices,

and patient interfacing tools. Medidata is considered too robust for most applications in the midtier market. Its toughest

competition comes from Oracle and in-house solutions. Newcomers to watch include DrugDev Inc. and MedNet. Less costly

solutions out of Eastern Europe also will challenge Medidata in the international market.


- 4 expect Medidata to experience sales growth but not in the 20% to 25% range.

- 1 thinks Medidata’s sales will be flat.

- Medidata software may be to robust for the midtier market.


- Market growth is expected due to pharma and CRO M&A and emerging trends that require new technology solutions.


- Oracle and in-house software are Medidata’s main competitors.

- Less costly solutions from Eastern Europe are expected to gain share.

1. Clinical affairs manager for a West Coast medical device company

Medidata has new products, and likely will expand its sales but not by as much as 20% to 25%. The company is

organized, helpful, and has dedicated project managers to talk with clients. However, its software has more features than

smaller companies need. Each of the small and large clinical trial software companies offers something worthwhile, but

small companies tend to go out of business while larger companies may not have the right software match.


“It is probably true that Medidata has extended their pipeline. Every time I’ve talked to one of their coordinators, they

have lots of new software. But companies always have a great pitch, and it is always about the pitch.”

“I can see Medidata expanding sales and growing but maybe not that much [20% to 25%].”

“I worked with Medidata when they were just starting. They were organized and always had a project manager come

to us. They had the capability of a dedicated programmer to talk to, and we had a person to articulate to the PM.”

“I felt comfortable with Medidata, and I liked their folks; they were willing to help out, and it was worth the

investment.”

We use Medidata frequently,

for many studies. I would say

their software is in high

demand if other centers and

companies use it as frequently

as we do.

Clinical Research Coordinator

Research Center, Florida

http://www.drugdev.org/


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“But we always got sold on modules that were too big and cumbersome. If

they could trim down their options, that would be good.”


“It makes sense to farm out a lot of the work. If you manage the data in-

house, you have to have one full-time person doing the data and one

manager. This takes a lot of time, and you may be better off working with

someone with lots of experience. It probably depends on the company, their

needs and employees.”

“I have worked with many different situations including Medidata software.

We have inside personnel build our own software. Our self-built system is

more efficient for what we do. If we need a change, it is easy to do that. I

have also worked with outsourcing, and it was a problem to go through

amendments. You pay so much money; then if you want to make a change, it

is a huge process and costs a lot of money.”

“It may cost as much as $150,000 to outsource, and it may not be

convenient. It depends on the company, and each is different. Startups may need to stay with small packages.”


“A number of companies sounded fabulous, but they have gone out of business. We had a contract with one

company that went bankrupt and then reopened as another business. It was very scary.”

2. CIO of a clinical research network in the United Kingdom

This source sees many areas for significant growth for technology in the United Kingdom. Companies like Medidata are

poised to take advantage of new areas in medical research big data as a commodity, demand for collaboration platforms,

wearable and mobile technology, and expansion of clinical trial information to consumers.


N/A


“There is expected growth in the technology side of clinical research this year. There’s a big, government-funded

push in the UK to improve both the quality and the time to deliver clinical research. The best and quickest way of

doing that is through use of information systems, in particular if it can be though accessing data that has been

already collected rather than creating new data sources. Both Oracle and Medidata have platforms that allow data to

come out of the clinical record, almost in real time, which will begin to move research in this direction.”


“There are lots of global companies positioning themselves to take advantage of the boom in clinical research and

healthcare big data. One is DrugDev, which focuses on creating a platform for researchers to work together and

share information and moving ideas forward.”

“The biggest change currently is the CRO marketplace. You’ve got Covance [Inc.] and Quintiles [Transnational

Holdings Inc.] that are making phenomenal stretches with technology and with data in particular. There’s a potential

shift in their business model where their product isn’t the trial anymore; it’s the data. They are really pushing our

understanding of what you can do with data. The information they have about every trial they’ve run going back X

number of years becomes their product that they can use it to do fast feasibility studies, locate trials more easily, to

push the envelope in that space even more.”

“Now we’re starting to see things like TransCelerate [BioPharma Inc.] where pharma are starting to collaborate more.

Five years ago you would never hear of pharma sharing data with each other. It’s a big, big change in how they think.

The competitive collaboration model lowers R&D costs for pharma. They can work collaboratively with CROs,

software vendors or data aggregators to reduce risks and costs and accelerate outcomes.”

“We have our own system for delivering data. Our major systems are on an Oracle infrastructure, but we don’t give

Oracle our data. We work with Medidata to help them locate trials in the UK because our job is to try to promote the

UK as place to conduct clinical research.”

“New technology areas in clinical research that are expanding are, first, empowering the patient to find a trial. There

are companies, such as TrialReach and all types of startup and investment organizations trying to open up data to

It is probably true that

Medidata has extended their

pipeline. Every time I’ve talked

to one of their coordinators,

they have lots of new software.

But companies always have a

great pitch, and it is always

about the pitch.

Clinical Affairs Manager

West Coast Medical Device Company

http://www.covance.com/

http://www.quintiles.com/

http://www.quintiles.com/

http://www.transceleratebiopharmainc.com/

http://trialreach.com/


9


allow either patients to find the trials themselves or … setting up a way for pharmaceutical companies to find

patients to take part in the trial. There’s a lot of work, investment and technology changes in this space.”

“Next is the idea of wearables and collecting data from patents on the move. We haven’t seen a trial happen with

this yet, but we’re hearing everyone talking about it. There’s a lot of talk about the suspected Apple [Inc./AAPL]

announcement about new healthcare apps on the new phone. There are a lot of people starting to think that

potentially there’s a marketplace that hasn’t been tapped into yet where the participant in the trial doesn’t have to

turn up at the medical clinic or the doctor’s office to have their data collected.”

“The clinical research focus of the UK is in dementia at the moment, where there’s a lot of investment. That’s the

biggest area where government policy and government spend is increasing capability to do research within the

national health system in the UK. Cancer is still the biggest area of research in the UK; 17% of cancer patients in the

UK take part in clinical research.”

3. CRO IT director with clinical research expertise

This source does not expect a surge in clinical trials. Any growth in the CTMS market could come from the rapid

consolidation of CROs. The five largest CROs are acquiring midsize companies. Deploying one standard CTMS

companywide would be logical. Medidata and Oracle are the lead players in CTMS.


N/A


“I’m not getting the sense at all that there will be significant growth in the CTMS market.”

“In the CRO market we’ve see the top five companies effectively swallowed up all of the medium-sized CROs, and

we’re down to the very small and boutique CROs remaining. To some extent that has helped the large CTMS

providers simply because it makes more sense to have one platform that will work across a much wider company.

There has been rapid absorption of the medium companies lately, not real growth in the market.”

“There is still a small area for the specialist boutiques in CRO. … The consolidation lately has just been commercial

sense. The big companies see a lot of potential in the market. They’re spurred on by speculative venture capitalists,

and many have leveraged themselves to buy up the small companies.”


“There has been something of a race to virtualize CTMS and create an app. It’s going to be happening more.”

“The top players now in CTMS are Medidata and Oracle by a far margin. I’ve seen some interesting new players in the

plug-ins and smaller add-on products but not in a full CTMS. For example, there’s a company that specializes in

device feedback that feeds into the larger CTMSs; they’re doing some fascinating things.”

4. Development consultant for two West Coast pharmaceutical companies

This source was unsure how Medidata sales will fare this year, given that companies tend to exaggerate their potential in

order to please investors. Most likely, Medidata has extended its pipeline, which should be a benefit. Meanwhile,

Medidata may not be savvy enough to play in the growing international market.

Pharma companies eventually may turn to less-expensive clinical trial

management services coming out of Eastern Europe.


“When all is said and done, there is a great deal more said than done. I’ve

learned that you can’t rely on a company press release; they change in 15

minutes, and the public information is not the gold reading. But there are

some constants. Everyone has the same general goals; the CEOs want

things to look as good as possible.”


“There is a high demand for clinical trial software, but the trend that I see in

both large and small companies is to outsource nearly everything and

I’m not sure how globally aware

Medidata is. Outsourcing is

becoming global. Trial research

costs one-third less in Eastern

Europe than it does here.

People will start looking for this

service.

Development Consultant

West Coast Pharmaceutical Companies

http://www.bidnessetc.com/business/apples-healthkit-platform-revolutionizing-the-healthcare-industry/


10


reduce their in-house rule in order to maintain control over spending money. It is less likely now that a company

would manage a clinical trial on its own.”

“If you are a new biotech and do not have this in-house expertise, then you will hire someone to watch over the

clinical trial data. You can decide a reasonable amount of expenditure, and then you are done. The client that owns

the property will get a big, thick report.”

“The service providers play a big role and can provide specializations only for a year or two.”

“The smallest companies are generally startups, with small trials in early phases. There is the likelihood that they

would purchase less software.”


“I’m not sure how globally aware Medidata is. Outsourcing is becoming global. Trial research costs one-third less in

Eastern Europe than it does here. People will start looking for this service.”

“Selling a product to the pharmas, this is a very dynamic situation with global challenges. Now it is an international

competitive landscape. To sell to the pharmas, you need to have the ability to translate across cultural and language

barriers.”

5. R&D project manager at a major CRO; repeat source

Business with Medidata is stable. Some clients continue to prefer Medidata, while others split use between Medidata

and Oracle. The source questioned whether 20% to 25% growth was possible in light of Medidata’s past robust sales.


“I don’t see any decrease in Medidata or increase. We still have some clients that prefer to use Medidata or they

split their work between Medidata and Oracle InForm. From our company standpoint, it’s business as usual. I have

no idea about their pipeline elsewhere, but for my company it’s the same.”

“[A growth rate of 20% to 25%] seems high to me because they’re not a new company, but that’s more from a stock

market perspective.”


N/A


“Medidata and Oracle are still the top two. I haven’t heard about new technologies. There’s a company called

MedNet that we’ve been asked to look into, but I don’t know more about them yet.”

3) Medidata Competitors’ Customers Three of these four sources expect Medidata to experience continued sales growth this year. The remaining source was

uncertain about its growth opportunities, but noted a need for new software in big pharma. The three sources who expect

Medidata to grow believe a rate of 20% to 25% could be achieved through mergers or by securing one or two large clients, but

they added that this kind of expansion takes time. All four sources expect the clinical trial market to broaden although one

source noted that growth in the university research setting will be slow. Medidata and Oracle are considered leaders in the

large pharma market segment, with each holding significant share. However, Parexel is the preferred CTMS provider in

Germany. Midsize and small pharma cannot afford Medidata, and also consider its products to be complicated. Competitors

favored by small pharma include Ginger.io, the REDCap Consortium (Research Electronic Data Capture) and GraphPad

Software Inc.’s Prism. Emerging trends include consolidation and standardization, capturing data in real time, and concerns

over security and data management in the cloud.


- 3 of 4 think Medidata can achieve growth in the 20% to 25% range through servicing companies that merge or

acquire, or by adding 1 or 2 large customers.


http://www.oracle.com/us/products/applications/health-sciences/e-clinical/inform-gtm/index.html

http://ginger.io/

http://www.project-redcap.org/

http://www.graphpad.com/scientific-software/prism/


11


- All 4 expect the CTMS market to grow.

- 1 said the university research market is constrained but that pharma is strong.


- Medidata and Oracle are leaders in the large pharma market segment.

- Parexel is a market leader in Germany.

- Small pharma prefers less costly and complicated software, opening the door to smaller and startup companies.

Trends

- Emerging trends include consolidation and standardization, capturing data in real time, and concerns over security

and data management in the cloud.

1. Former clinical operations manager for a diagnostic company

This clinical trials manager has Medidata and Oracle Clinical experience and said mergers may make Medidata’s growth

prospects possible but that changes take one year or more. Medidata’s Rave can be complex, and the company’s prices

are too high for smaller companies. Capturing real-time data is an important trend.


“With all these mergers [Medidata reaching its sales forecast is] a

possibility, but it takes a year to a year and a half to make any changes.”

“They’re priced too high; they’re too expensive for smaller companies. … I

don’t know about their selling multiple products to large pharma.”

“Some of Medidata’s products are not user-friendly and are complicated.

Others are better modified to capture data. … The most important thing is it

has to be super user-friendly.”

“I don’t know how it’s going to play out. There are lots of different changes,

such as looking at real-time data that goes to the pharmaceutical company

and the physician so they can make decisions. Medidata’s not standing out

because everyone is jumping into it.”

“Medidata’s strength is they’ve always penetrated the top ones and people keep using it. Medidata’s weakness is

they need to make their Rave more user-friendly. They also need to have a better price.”


“There are so many more studies are going on and more emphasis on real-time data.”

“Bigger companies are modifying whatever they have existing for their needs. Smaller companies will find a vendor

who fits in their budget. Many prices are too high.”


“Most are getting the biggest ones—Oracle and Medidata.”

“Ginger.io is a company that is using this big data to do it real-time. They collect real-time data. I would check into

them.”

Trends

N/A

2. Clinical trial coordinator at a Midwest university medical center

Medidata updates its products to meet the needs of large pharma, which in turn probably boosts the company’s sales.

Still, this source was uncertain how high Medidata’s sales could grow. Teaching hospitals are limited by restricted

budgets; they often use lesser-known software such as REDCap and GraphPad’s Prism. She has heard that Medidata’s

products are expensive and have rigid navigation.


“There is a need for new software, especially in big pharma, so it could be that Medidata has new products to offer.”

“Given that big pharma has money, they may boost Medidata’s sales, but I don’t know by how much. Large pharma

attempts to get facts about products, and they would purchase data software.”

With all these mergers

[Medidata reaching its sales

forecast is] a possibility, but it

takes a year to a year and a

half to make any changes.

Former Clinical Operations Manager

Diagnostic Company


12


“I’ve heard that the Medidata software is rigid in terms of navigation … but

fairly comprehensive.”

“Medidata has a high purchase price. You need to check carefully and see

what features are offered and if they are something you could use.”

“I was at a conference recently, and I don’t remember seeing Medidata.

They were probably there but didn’t stand out.”


“The economy determines what actually happens with the clinical trial

market. When the economy is not strong, such as has been the case for the

past few years, we all have to back off, at least those at teaching hospitals.

We aren’t looking for new software at this point. The issue is, can we make

what we have work? We are always trying to figure out how to do something on little to no money. That is just the way

it is.”

“The large pharmaceutical companies probably have the most money to buy more updated software.”


“Teaching hospitals get their licenses for various software from companies that not all folks are familiar with. Our

core statistics department helps with research, and they purchase the software. We use REDCap and GraphPad

Prism for statistical purposes.”

Trends

N/A

3. Manager of European life sciences accounts for a technology consultancy and Oracle partner

This IT pro expects growth in the clinical trial sector this year as large pharma companies bounce back from patent

expirations and small pharma develops more generics. The source also cited a movement among pharma companies to

consolidate and standardize CTMS systems.


“Medidata is pretty bullish for a reason, but 20% to 25% growth could be a little optimistic. In reality, if they bag one

or two major new clients this year, there’s your 20% growth.”

“Some Medidata growth this year may come from the emergence [of more clinical studies] of the patent cliff, so

especially large CTMS companies are looking at a quite promising pipeline.”

“Other growth will come from the desire in the industry to continue to

standardize approaches and standardize on software. Pharma, CROs and

others now want to move to more standardized systems in order to manage

and leverage larger amounts of data in a more coherent way.”

“If you want to move from custom application to a completely new platform

like Medidata, there’s a lot of integration work to be done and the time

frame could be upwards of a year. I know that some of our clients have

moved away from custom platforms to standardization.”


“We’re not seeing new purchases of Medidata or the large vendors from our

clients this year, but there are people wanting to make bolder plays to

integrate and package their systems together.”

“Where there’s an established platform like Medidata and Oracle, you’re

going to see that platform getting more licenses and more users. Instead of new customers, there’s sort a volume up

and expansion to gain leverage in their existing investments.”

“There’s really a gap between the very large solutions and the very small startups. Smaller players will continue to

proliferate as long as shadow IT is still around. But these larger companies are going to try to fold in as much of the

innovations from startups as they can.”


“Generally we’re seeing consolidation, not more competition in the CTMS space.”

Trends

There is a need for new

software, especially in big

pharma, so it could be that

Medidata has new products to

offer.

Clinical Trial Coordinator

Midwest University Medical Center

Medidata is pretty bullish for a

reason, but 20% to 25% growth

could be a little optimistic. In

reality, if they bag one or two

major new clients this year,

there’s your 20% growth.

Manager, European Life Sciences

Accounts

Tech Consultancy & Oracle Partner

http://en.wikipedia.org/wiki/Shadow_IT


13


“We’re building collaboration platforms on Oracle between some of our life sciences clients where they can share

data securely, and then once the collaboration is ended they can take back the data. It’s an evolving business model

among our pharma customers.”

“The UK is really pushing its interest in—and funding of—creating a open environment for clinical trials. Other

countries in Europe could follow suit, driving up clinical trials.”

4. Manager of clinical data and CTMS systems for several German pharmaceutical companies

The CTMS market is rapidly growing because of changes in data demands of clinical trials and regulators, but large

pharma in Germany currently favors Parexel over Medidata because of the former’s cloud-based system.


“Medidata sales could be as high as 20% but only if they take market share from one of the other CTMS vendors.”


“One of the driving factors in the growth of CTMS here is the further consolidation of systems and the integration of

data, such as business intelligence and metrics, into all areas of trials.”

“There’s also a trend to go to hosted solutions. Pharmaceutical companies are looking for cloud-based solutions.”

“The variety of trials has grown. People are looking for software solutions with a lot of flexibility and functionality and

they are asking their vendors to deliver more. A lot of companies routinely look for new vendors as needs change.”

“CTMS is becoming more externalized; companies are looking for cloud-based solutions to facilitate collaboration

with CROs and other entities.”

“If you have a hosted platform that is also open to the outside for external

partners, you have a logistic advantage here. It makes it definitely easier to

incorporate and ramp up external partners faster.”


“Medidata is not quite there yet in Europe. Oracle plays a role, but I think

Parexel Informatics has a big stake in Europe definitely.”

“I ran the CTMS systems at another large pharmaceutical company when

they changed systems. They went for one major vendor who they felt had

enough experience: Parexel.”

“From time to time all the companies go and challenge their CTMS vendors

to deliver more and analyze their vendor solutions and look for new ones.

For us, we had a custom solution but decided to go for a vendor with a hosted solution: Parexel.”

Trends

“Security is still a concern with CTMS as a cloud-hosted solution. It’s the big topic: how to validate where the data is,

in what country is it stores, who owns the data, what happens to the data when a partner disbands. I believe all

pharma companies would like to outsource this job more and put the burden of validation somewhere outside of the

company, but on the other side you still have the responsibility of data protection and security in general. Contracts

that need to be revised to handle these concerns.”

4) Medidata Competitors Two of these four sources said Medidata’s growth would not continue this year. However, two others said its sales could

increase further, and one said reaching the 20% to 25% forecast even was possible; these two sources credited Medidata’s

strong reputation and longevity, the current high demand for cloud-based solutions, and the lack of strong competitors. The

detractors said Medidata would be challenged by its high pricing, its lack of responsiveness to customers and the saturated

big pharma segment. Major competitors include Oracle, OmniComm, BioClinica, Parexel, Datatrak, Nextrials Inc., OpenClinica

and Merge. The CTMS market is growing as pharma does more outsourcing of trials. New industry trends include greater

demand for risk management, electronic health record (HER) integration, and mobile apps for patients.

Medidata sales could be as

high as 20% but only if they

take market share from one of

the other CTMS vendors.

Manager, Clinical Data & CTMS

Systems

German Pharmaceutical Companies

http://www.nextrials.com/


14



- 2 said Medidata could achieve 20% to 25% growth.

- 2 do not think Medidata will achieve 20% to 25% growth and said its growth will be curtailed this year.


- All 4 sources expect CTMS demand to increase.

- Demand also is high for cloud-based clinical trial management solutions.


- Oracle and Medidata dominate the large pharma market.

- Large pharma is opening up to some of the newer technologies from competitors.

Trends

- Trends include the demand for risk management, EHR integration, cloud-based solutions and mobile apps.

1. Clinical director at a Medidata competitor

This source was unsure why Medidata did not do as well as her company in the first quarter, but said Medidata’s

entrenchment, track record, staffing and delivery bode well for future growth. Its pricing, however, needs to be lowered in

order for it to succeed among smaller pharma. Cloud-based, risk-based monitoring and electronically transmitted data

are major trends.


“We’re all in the same business, and we didn’t have trouble in the first half. I don’t know why they did. I do think

Medidata has a lot of people; they don’t run very lean and maybe they’re top-heavy. They have 20 [salespeople]. …

But they are in markets like Asia that we aren’t, so maybe that’s why.”

“The quote we hear is nobody gets fired for hiring Medidata. They’re a safe

pick. I don’t know about their pipeline but, yes, I think they’ll do well.”

“They got in at the right time and will be able to offer more products [to their

customer base].”

“We see [Medidata as] more competitive on the EDC side, not as much in

CTMS. They definitely have to drop their price to be competitive. They tend

to be a better fit for larger companies with a lot of users.”

“Their strength is they’re the biggest company with the most resources and

they have a long track record. There are no issues with delivery, so they’re

good with timelines. Their weakness is they are more expensive than most.”


“We’re definitely seeing more outsourcing, more to niche than to CROs, but

unfortunately we’re seeing more outsourcing to India. Also, we’ve had more

sponsors come to us that use several different CTMS programs through a

CRO. They don’t want to log into the CRO’s CTMS, and they want to pull all the data into one.”

“All the big guys have [CTMS]; all the middle guys are looking to get one. But we’re also seeing a lot of companies

who have CTMS shopping around for another vendor. It’s interesting. We see a lot of people who aren’t happy with

[Oracle’s] InForm. We see companies that have acquisitions saying, ‘Let’s do a reevaluation.’ Acquisitions are big.”


“I don’t know of any newcomers. I walked around the DIA [Drug Information Association] exhibit, but I can’t think of

anyone.”

Trends

“Customers want cloud-based solutions. Sponsors are going different directions and letting vendors host the data. A

big future trend is more patient-related technology where patients in clinical trials report findings on cell phones or

through web servers. Also, having data electronically sourced data such as through blood pressure cuffs. And the big

buzzword is risk-based monitoring. Everybody either has been doing it for years but didn’t call it that, or fall into the

more conservative types who haven’t done it or on the fence. But the technology has improved where you can more

easily track what you do, and that adds quality to your site.”

Their strength is they’re the

biggest company with the most

resources and they have a long

track record. There are no

issues with delivery, so they’re

good with timelines. Their

weakness is they are more

expensive than most.

Clinical Director, Medidata Competitor

http://www.diahome.org/en-US.aspx


15


2. COO of a risk-based competitor in Europe

The source was unable to comment on Medidata’s sales pipeline, but said the company has been focusing on other

areas of the market, finding other ways to collect data, and pushing R&D. Medidata always makes bold statements and

has been known to “achieve wild expectations”; 20% to 25% growth may be attainable. The time is right for the company

to focus on midsize CROs and pharmas. No other competitors are significantly pressuring it. Risk-based monitoring is the

hot topic in this field and should be watched.


“I’m not sure if their pipeline has doubled, but Medidata has increased its level of focusing on other areas of the

market such as other ways to collect data.”

“Medidata has pushed their R&D aspects, and I expect they would want to see growth for their investors. They could

not reach 50% to 60% growth this year, but 20% to 25% is not impossible.”

“Medidata always sets its sights high. They are always bold in their approach to the investors. But they have

achieved wild expectations on occasion, and they have got from nothing to where they are today. You need to

respect the fact that they are lasting players in the market. They have done a good job.”

“Medidata added more modules to their products such as the SQM orbiting software.”

“This is a good time for software companies to work with other smaller and

medium-sized pharma and CRO companies. This is a better growth area for

tech in other sectors. I’m not sure why Medidata couldn’t go after these

companies as long as their price doesn’t make it an impossibility.”


“The market is burgeoning. It is always competitive. There are many

changes. New CROs are taking a different approach; they are growing. As a

whole the industry is up, and CROs are doing well. The industry has come

out of its holding pattern, and there are more drugs in the pipeline.”

“The market is conservative in nature, and it takes awhile for something to

catch on. But the growth potential is vast.”

“Large pharmas are strategically going to large CROs like Quintiles. The

larger companies are spending more on technology; they are a larger cash

cow, but I have no data on any of this.”

“There is a divide. The big boys are doing strategic outsourcing to one or

two vendors, while the smaller guys do the work themselves. But this is a trend right now, and it will change.”

“The large CROs and some of the medium-sized pharmas are already buying Medidata’s software.”


“Oracle has a new approach to electronic data capture. After that, it is hard to say who are the next competitors.

Everyone else would tell you they are No. 3. No one else is pushing Medidata hard.”

Trends

“The UK is not a good benchmark for the industry in general.”

“Risk-based monitoring is the industry’s hot topic at the moment. It is making good headways, with a good story to

tell. This should not be underestimated.”

3. President of a Medidata competitor; repeat source

This competitor is less positive about Medidata than he was in Blueshift’s December report, as he doubts the company

can continue its past robust growth. Based on conversations he had at the recent DIA meeting, he said Medidata may be

struggling with its clinical cloud, and he questioned its ability to compete in the price-conscious middle to small markets.

More clinical trials and outsourcing are fueling industry growth, and large companies are increasingly choosing smaller

vendors over Medidata and Oracle.


“It’s difficult to imagine [that they have twice the pipeline of last year] because they had such a good-sized pipeline

one year ago. They had locked up two big accounts in 2013, and that really helped drive their business. If that is true

Medidata has pushed their

R&D aspects, and I expect they

would want to see growth for

their investors. They could not

reach 50% to 60% growth this

year, but 20% to 25% is not

impossible.

COO, Risk-based Competitor

Europe

http://www.mdsol.com/products/sqm


16


[about their pipeline] they have to get it through the cloud market and the middle market with their complementary

solutions. I’m hearing in the industry that their cloud solution isn’t as mature as they make it out to be, and that

could pose issues for growth. It’s an ASP [application server provider] enterprise offering, but they’re capitalizing on

the fact that most people don’t really know what a cloud is.”

“As they go more downstream into the middle market, the bigger the price pressures they run into. Oracle is where

the market share is. The midtier market doesn’t care about the big names as much as they want a good price.

Medidata is going to struggle to compete in that market. They’re expanding into other markets like the Asia Pacific

market, so that may help.”

“Being a conservative business that likes to do business with the market leaders, Medidata’s market share is their

biggest strength. But I think they’re taking their eye off the ball, with no new releases with their core product line and

their lack of innovation in key areas like custom exporting and risk-based monitoring. Instead, they’re relying on their

ancillary solutions and their clinical cloud to bolster sales. They’re making the same mistake Oracle did seven to

eight years ago when they stopped focusing on their core clinical product line.”


“The market as a whole is seeing a major rebounding. There are more

clinical trials being done. … Outsourcing is at an all-time high with the larger

companies, who didn’t want to be in the business to manage e-clinical

solutions outsourcing it. Some large pharmas have hundreds of IT folks

managing these complex e-clinical solutions, and many companies are

trying to get away from this. Major CROs are also looking to offload this IT

burden.”

“The FDA is taking a more pragmatic approach in how data is collected,

qualified and monitored; the industry is moving toward a risk-based

approach. Most companies are a little nervous to implement the first

strategies, so they’re looking to others to be the first. But implementing

solutions like risk-based monitoring, EHR integration, e-sourcing or

capturing clinical data with handheld devices are an important paradigm

shift that needs to happen for our industry to progress.”

“Mergers are definitely going to continue as larger companies gobble up

smaller ones in an effort to expand their pipelines and diversify. This is also

true on the vendor side. Although it seems to be slowing down, I think the

trend will definitely continue. We’ve done three acquisitions in the last four years, adding some different product

lines; it’s a great way for us to expand our business in a relatively short amount of time. There are lots of good new

technologies out there that may otherwise not see the light of day if not for these acquisitions.”

“You’re starting to see it push down into smaller markets for companies like Oracle and Medidata with the larger

market mostly locked up. Medidata knows that the really large contracts are going to become harder to find unless

there are renewals, so to continue to grow they must find other ways. In years past it was a land grab for all the big

companies, but now the focus is to go to their existing customer base and sell everything else to expand market

share. … Their clinical cloud is a big part of that as many companies are now looking for outsourced, enterprise

solutions in a consumption based, pay-as-you-go model.”


“Even the largest companies are more likely to go with some of the smaller vendors than they have in years past,

due to the evolution and maturity of these other technologies. We’re having our best year ever because the industry

is waking up and realizing that the major players have lost focus. Oracle has been struggling the past several years;

they’re shedding significant market share very rapidly. Both their Oracle Clinical and even their InForm product

haven’t brought on any appreciable new business in the last few years. And Medidata sales have begun to slow

down as well.”

“The major vendors are the same ones I mentioned the last time [Oracle, Medidata, OmniComm, BioClinica, Parexel,

Datatrak and Merge].”

“You’ll always see new companies popping up that focus on certain niches like late stage or early stage or maybe a

specific therapeutic class like oncology, but it’s very difficult to enter this market due to the conservative nature of

this industry. In EDC we don’t see a lot of new players. However, as the industry evolves and regulations change, like

with risk-based monitoring, you will begin to see new companies popping up to capitalize on this. For example,

CluePoints and Triumph Consultancy Services have developed specialized solutions to help measure risk in a trial.”

You’re starting to see it push

down into smaller markets for

companies like Oracle and

Medidata with the larger

market mostly locked up.

Medidata knows that the really

large contracts are going to

become harder to find unless

there are renewals, so to

continue to grow they must find

other ways.

President, Medidata Competitor

http://www.cluepoints.com/

http://www.triumphconsultancy.com/aboutus.html


17


Trends

N/A

4. Director of business development for a West Coast competitor

Medidata has been in the news for false reporting. It has not improved its products, and it will not reach sales growth of

20% to 25%. Large pharma companies contribute to Medidata’s sales, but they may start to look elsewhere for updated

products. Midsized to small biotech and medical device companies cannot afford Medidata’s prices, and they do not

need a large, complete package. Additionally, Medidata is not responsive to customer needs. New trends include

integrating with EHRs and mobile apps for patients.


“It is not true that Medidata has doubled their pipeline. Recently Medidata was in the news for false reporting, and

some of their numbers were fictional.”

“Medidata is misreporting and upping their numbers, such as increasing by 20% to 25% this year, because I think

they are sliding downward. Companies come and go, but if you haven’t improved your core product in a few years,

you can end up with a Frankenstein. Just compare AT&T a few years ago to now.”

“Larger pharmas or CROs are up to twice the sales as other offerings. Large pharmas will continue to use Medidata

for brand recognition. But they may also start looking at other companies.”

“Mid- to small-size biotech and medical device companies cannot afford a

Medidata product. Medidata will need to bring the price down a bit to

capture these companies.”

“Medidata sells on the fact that they are the biggest and largest provider.

But you need to buy their whole package, and that comes with a hefty price

tag. The smaller companies don’t need it all.”

“Medidata’s positives are recognition in the market. On the negative side,

they haven’t improved their core product. Programming languages are

evolving, and Medidata still uses a reverse Polish notation, making it hard

to copy data bases and make changes. This is another major complaint

about Medidata: It is very expensive to make changes, which are often

required by the FDA.”

“From what we hear from our customers, Medidata is not responsive to their needs.”


“Clinical trial software is still in demand and will be for as long as people use drugs and we have the FDA.”

“With the economy increasing, there will be a demand for more research. Companies of all sizes, all sectors use this

type of software.”

“More companies are hiring out. CROs are especially being used by smaller companies; they want someone to do

their leg work. Large companies do not use CROs as much.”


“Medidata and Oracle are the top electronic data capture players, followed by Nextrials and OpenClinica. Oracle is

the primary data base company, which is different from clinical trials.”

Trends

“There are two important things to keep in mind: 1) Integration with electronic health records is part of the

meaningful use contract. You have to prove that you are doing more with technology and are increasing more in a

few years. 2) Mobile applications will become more visible, and patients will want their own data.”

5) Industry Specialists These four sources expect Medidata’s sales growth to continue this year, thanks to capturing market share from Oracle, the

pharma M&A trends, and CROs and pharma abandoning in-house clinical trial software. However, achieving 20% to 25%

growth in a saturated market will be a challenge. Also, Medidata will have some difficulty expanding into the smaller markets,

Mid- to small-size biotech and

medical device companies

cannot afford a Medidata

product. Medidata will need to

bring the price down a bit to

capture these companies.

Director of Business Development

West Coast Competitor

http://www.businesswire.com/news/home/20140422006800/en/ATTENTION-MEDIDATA-SHAREHOLDERS-Shareholder-Rights-Law-Firm#.U7XF2LEQm1k

http://shareholdersfoundation.com/caseinvestigation/medidata-solutions-inc-nasdaqmdso-investor-investigation-concerning-potential-secu

http://webcache.googleusercontent.com/search?q=cache:bxx2Wliz4QQJ:www.nextrials.com/wp-content/uploads/2011/10/cwm1810_nextrials.pdf+&cd=1&hl=en&ct=clnk&gl=us&client=firefox-a

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm?utm_source=twitterfeed&utm_medium=twitter

http://en.wikipedia.org/wiki/Reverse_Polish_notation

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm?utm_source=twitterfeed&utm_medium=twitter


18


but its modular products may be of interest if offered as a pay-as-you-go model. Competition comes from Oracle, Parexel and

BioClinica in the midtier.


- All 4 expect Medidata’s growth to continue.

- Medidata is unlikely to achieve 20% to 25% as the high end of the market is saturated.


- Oracle’s market share loss, industry M&A, and pharma’s migration from in-house software are fueling market growth.


- The market is competitive. Medidata competes primarily with Oracle on the high end and BioClinica at the midmarket

level.

- Startups introducing cloud-based solutions without legacy products are also competing for market share.

Trends

- Key trends include big data acquisition, management and analytics, risk management to satisfy regulatory

requirements, and standard data formatting.

1. Clinical data management consultant with 25 years’ experience; repeat source

Medidata continues to be unattainable to the small companies consulted by this source, but he praised the company and

its products. Mergers among pharma and CROs likely are helping Medidata’s market share, but gains will not occur for six

months or more post-merger. Forte Research Systems Inc. is a new competitor of interest.


“They still aren’t represented in any of my deals, but at most I work with five clients at a time. One group that has

approached me about working with them is financed by an investor group that knew [Medidata’s] Rave and went

with it.”

“[As for future growth] you would probably want to look at all the mergers. … The big companies are gobbling up

small companies. As these companies merge, they’re gaining themselves more business and more market share.”

“I have noticed on their Twitter that [Medidata is] doing a big campaign on being more than just CTMS. They really

are trying to get the message out they’re more than just Rave.”

“People I talk to seem to agree that they’re not approachable. People using

them love them, and I would love them but my clients can’t afford them.”

“I have a very positive impression of them. They would be my provider of

choice in terms of what they offer.”


“I haven’t seen any real pricing movements on the part of the smaller

players. I did notice recently that Medrio has started making their product

free to academia. This is an interesting model since it exposes students to

their product, and they may be more likely to purchase it when they

graduate and move to industry.”

“It’s hard to say [which segment is more active]. Large and midsize pharma

will have larger individual contracts. From a business sense, a company

could be better off with a smaller number of larger pharma contracts than

with hundreds of small pharma contracts. More customers mean a need for

more support staff, etc. … All segments are active since any pharma or

biotech company not engaged in clinical trials will not survive long as

existing patents expire.”


“It’s hard to change market share although standards will make it easier. It

will depend on what happens with all these mergers, especially a client that

gets bought out by someone bigger. Some think the government will stop it.

[Medidata] started pooling all

the data collected, which all

goes in anonymously, so they

can offer comparative data. On

average you can find out, for

example, that doctors are paid

on average $200 in New York

City versus $50 in a small

town. I don’t know anyone else

offering that, but it’s certainly

something I would love to have

when sitting down to do a

budget. It’s a valuable service.

Clinical Data Management Consultant

25 years’ Experience

http://forteresearch.com/

https://twitter.com/Medidata

http://medrio.com/


19


There are two reasons for consolidation: A company has the expertise you want, or you want to get rid of competition.

They gobble up the small CROs. I think that will favor a big company like Medidata.“

“After a merger, it depends on what happens a year down the road. It affects new studies after the decision is made,

so that’s six months to a year.”

“Oracle and Medidata are still the top ones and, as last time, OmniComm, Merge, [Parexel] and Datatrak are other

competitors.”

“I just know of incremental growth [in product releases]. Datatrak recently came out with some new stuff. MedNet is

a midsized company that has released more. They have a model where they sell through consultants like me, and

you get a cut. Some like that, but for me there’s a conflict of interest.”

“Forte out of Madison, WI, is starting to pick up. They’ve been around for 10 years and have been geared to

academia and hospital centers. But a couple years ago they spun off a commercial product, Overture, that is doing

very well. It’s not as versatile as Rave, but they’re making big programming changes to address some of its issues.”

Trends

“[Medidata] started pooling all the data collected, which all goes in anonymously, so they can offer comparative data.

On average you can find out, for example, that doctors are paid on average $200 in New York City versus $50 in a

small town. I don’t know anyone else offering that, but it’s certainly something I would love to have when sitting down

to do a budget. It’s a valuable service, but I haven’t checked into it since it’s probably expensive.”

2. Global lead of a life sciences software and IT consultancy based in the United Kingdom

This source sees growth for Medidata in offering cloud-based, lower-cost alternatives to the small and midsize pharma

and device markets, as well as from midsize and large CROs that will license its suite of products because their

“homegrown” systems no longer can compete with the breadth of Medidata’s features.


“On the surface, 25% growth does look a bit ambitious. Are there going to be 25% more clinical trials conducted next

year? No, clearly not.”

“There’s a continual turnover in investments in new technology in this market but nothing that’s going to drive 25%

growth.”

“The AstraZenecas and GSKs invested in these platforms a long time age,

but even they are outsourcing to CROs. These large companies can account

for some of the growth in product suites and add-on software for companies

like Medidata.”


“Where growth is coming from is some of the smaller organizations. … In

the past few years we’ve started to see more focus on those homegrown

systems, developed by large research hospitals or by CROs and so on. I’ve

seen a flood of these systems in the past few years, and everyone has had

regulatory compliance issues.”

“The FDA has published and is finalizing new guidance in terms of key

issues around control systems, and I think it’s causing some organizations

to ask themselves the question ‘Can we afford to make our homegrown systems compliant, or should we invest in a

known provider?’ It’s also causing some customers of those organizations to ask the question ‘Do we really want to

use your systems if it’s not fully compliant?’”

“We’ll start to see a lot of the smaller players have compliance issues. Now this wouldn’t normally have been a

opening for some of the big players like Medidata and Oracle to enter the smaller market because their solutions

aren’t cheap, but with the cloud and software-as-a-service, smaller organizations can begin to use cloud-based

solutions on a pay-as-you-go model.”

“We are seeing more growth in the customer base of companies with cloud-based CTMS offerings. Cloud is what’s

driving a lot of the growth in the small to medium end of the market.”


“We’re seeing the beginning of CROs licensing the software of the big players like Medidata instead of using their

own. The CROs are asking themselves, ‘What is our core business? Do we run clinical trials or do we build software?’

There’s a continual turnover in

investments in new technology

in this market but nothing

that’s going to drive 25%

growth.

Global Lead, Life Sciences Software &

IT Consultancy, United Kingdom

http://forteresearch.com/news/tag/overture-edc/


20


The software available from the larger players offers so many features and interconnectivity, not to mention cloud-

based and mobile-ready, that CROs are unable to match it with their own systems.”

“Some of the niche players in data modeling are working with the big players … to be able to build these data

standards into their systems. Although the big players claim that standards all built in, it’s very technical.”

“You’re seeing CROs saying, ‘We can’t continue to develop the functions that our sponsors want in the time frame

that they want.’ Unless you’re fundamentally a software development house, it’s impossible to incorporate all the

tools people want to day in a CTMS system.”

“I am still seeing new companies in the CTMS space every year. It’s a continual trend that small organizations see a

niche or challenge in the market and develop a specific tool for it but at the end of the day they’re never going to

match the functional breadth of the likes of the Medidatas or Oracles.”

Trends

“We are seeing a new demand for technology in the clinical data management side stemming from new data

standards. In the past, data was stored and compared in a CSV format, and new data had to be converted to that

format. Today organizations want data from trials faster and already in a useable, comparable format.”

“The big players are getting some of these clinical trial systems updated to meet the demand for the new data

format standard, and I’m seeing some of the companies on projects I’m working in leveraging that feature to say

they can shorten the time of clinical trials. There’s an advantage of having a standard to clinical trial data that

technology companies are starting to key into.”

“In the last 12 months every RFP [request for proposal] I’ve seen on the clinical trial management side has been

about the ability to manage clinical trial data in CSV format.”

3. President of a regional professional association

Medidata’s sales may rise 20% to 25% because of its expanded pipeline and extended customer contracts. The company

will continue to sell to large pharmas, which can afford both to buy software and to outsource. Small and midsize

companies must outsource to be cost-effective. Medidata is responsive to problems and competes with local software

companies in the source’s area.


“I’m not sure if Medidata has doubled their pipeline, but it wouldn’t surprise

me. It could be possible.”

“A growth of 20% to 25% is not outrageous. Anything is possible. Most any

place I’ve worked for, they make financial decisions based on the midyear

fiscal year. It is unreasonable to make changes and buy new software at the

end of the year, with the holidays. Software contracts are made for several

years, and Medidata may be basing this growth on some of the new

contracts, knowing that other contracts are set.”

“There is speculation that the midsized companies are a good market.

Small and midsized companies would need to outsource.”

“Medidata software works OK for what we need it for. We find the company

to be pretty responsive, and we get good feedback. This morning I had a

problem, and they will try to resolve it in a few days. I have had a problem

with the testing side.”


“There is a big demand for data capture. The majority of any sites we

monitor and interact with are moving to EDC. Paper is out.”

“Many are farming out and working with CROs. This is occurring regardless

of pharmaceutical size. You need to be really big to not outsource; it is more

cost-effective. Outsourcing has certain limitations, but they seem to be

minor.”

“Large companies can afford to buy software and farm out.”


I’m not sure if Medidata has

doubled their pipeline, but it

wouldn’t surprise me. It could

be possible. … A growth of 20%

to 25% is not outrageous.

Anything is possible. Most any

place I’ve worked for, they

make financial decisions based

on the midyear fiscal year. It is

unreasonable to make changes

and buy new software at the

end of the year, with the

holidays. Software contracts

are made for several years, and

Medidata may be basing this

growth on some of the new

contracts, knowing that other

contracts are set.

President

Regional Professional Association

http://en.wikipedia.org/wiki/Comma-separated_values


21


“We only use Medidata software, but the hospital we are connected with uses other software. I believe they use

REDCap and also software from Frank Hutch [Frank Hutchinson Cancer Research Center].”

Trends

“The software users have very little input as to the type of software that is bought. Upper management makes the

decisions even though they may or may not use the software. It has not really been a problem for us.”

4. Duncan Hall, CTMS consultant to large and midsized companies in the life sciences industry

Mr. Hall said customers are moving away from Oracle but not enough to generate 20% to 25% growth for Medidata in the

saturated top tier of the CTMS market. Medidata may see success in its new strategy to unbundle its suite of products in

order to appeal to the midtier of pharmaceutical companies and CROs that have not yet made large CTMS investments.


“The move I’ve seen away from Oracle creates an opportunity for Medidata,

but I wouldn’t say there’s an opportunity that will be driving 25% growth.”

“Fundamentally most companies are using Medidata, Oracle, [Parexel],

using something they’ve built themselves, or there a spattering of the next

tier of companies like BioClinica that are starting to appear. But there’s not

an awful lot of green fields out there to go and win new business with, so

the only way that companies like Medidata are going to gain new ground is

by pushing out companies … that are already there or moving to the middle

tier of companies, who are still in the process of adopting enterprise

solutions.”


“The idea of a cloud-based system is attracting the midtier as well. That seems to be where people are spending

their money now. There’s been a definite mind shift over the last two or three years that the cloud is not the security

risk that everyone thought it was.”

“The convenience of the cloud, the relatively short startup time, the ability to scale up and scale down quickly are

very much where people want to be right now. The companies that have started in the cloud, some of the newer

businesses have a much better story to tell because they’re not trying to reverse-engineer their technology into the

cloud. Those companies are in better shape, but we’re seeing all the big three offering a hosted cloud environment.

Yet this is not a game changer—more of just catch-up with the rest of the market.”

“Most of the big pharma have signed strategic partnerships with CROs over

the last couple of years, and that is a significant trend right now.”


“The top tier of companies in the CTMS market is fairly saturated at the

moment. We work with quite a few of the top CTMS companies, and we

work with people who work with the rest of them.”

“There’s definitely a move away from Oracle at the moment. I’m seeing

more people moving from Oracle looking at other possibilities. Oracle has

grossly underinvested in its platform. In fact, the entire Health Sciences

business unit within Oracle is in flux and has been for a while.”

“Where I see these CTMS companies looking for business now is moving

down a tier to midrange CROs and pharmaceutical companies. That’s

where the battle is going to be fought over the next few years—over the

500- to 3,000-employee size companies. These are companies in this

midrange that haven’t made big technical strategic decisions yet, but they are smaller projects with small budgets so

they’re harder to win and also less likely to buy technology at the enterprise level. For this reason, the big vendors

are going to have to be prepared and technically capable of modularizing their offerings as well as being able to

integrate with existing technologies.”

“Medidata, [Parexel] and Oracle have for years positioned their products as the big platform, the stable platform, as

the robust scalable platform that you need if you’re a Pfizer or a Boehringer. Their pitch has been around the fact

that their platforms have everything. … But that’s not necessarily what the midtier is looking for. So these companies

The move I’ve seen away from

Oracle creates an opportunity

for Medidata, but I wouldn’t say

there’s an opportunity that will

be driving 25% growth.

CTMS Consultant

Life Sciences Industry

These companies are adjusting

their pitch to say their

platforms are modular, they

can be broken up, so

companies can have a bit of

this and a bit of that. This

appeals more to the midtier.

CTMS Consultant

Life Sciences Industry

http://www.fhcrc.org/en.html

https://www.oracle.com/industries/health-sciences/index.html


22


are adjusting their pitch to say their platforms are modular, they can be broken up, so companies can have a bit of

this and a bit of that. This appeals more to the midtier.”

Trends

“When you look at the technology in use today, it’s what you’d have seen at a trade show five or six years ago.

There’s a very slow rate of adoption of new technology in this industry and frankly companies aren’t out there looking

for the latest and greatest, they’re just looking for something that’s going to work because it’s a very conservative

industry, there are very long sales cycles.”

“People want clinical trial data in real time, but in reality that is a long way off. … Especially when you have that

vendor-sponsor relationship, there are so many delays in the chain of data entry and review that real time just isn’t

happening.”

“When it comes to wearables, there’s only so much it can report. While it can measure your heart rate or blood

pressure, you can’t measure the size of a tumor through a watch. Certainly we’re a long way, yet it’s a step in the

right direction. It’s just a way for companies to show that they are innovative and get their names out there.”

“I’m not working with anyone who’s thinking, ‘We’ve got to get a technology that’s wearable-compatible.’ No, they’re

thinking, ‘I need to be compliant, I need to get control of my processes and data, I need consistent reporting.’ It’s just

basic elements that the industry is still struggling with.”

“Risk-based monitoring is very much how the market is showing that they’re addressing the regulatory problems and

how they’re going to stop throwing away money on inefficient trial sites. In order to reduce time on-site, which is

where money savings is coming from, CROs and pharma need to very well define and produce a clear audit trail on

how quality has been managed. It is the way clinical trials are going.”

“Medidata is also incorporating this technology as an add-on to their own platforms. Yet they’re just adding these

visualizations on top of their own data, not really dealing with the operational side of risk management and quality

management. They will all start to work toward that over time.”

Secondary Sources

The following five secondary sources discussed the growing global CTMS market, OmniComm’s contract wins, and recent

acquisitions made by Medidata’s competitors.

CTMS Market and Contract Wins These three sources centered on growth in the global CTMS market and on OmniComm’s TrialMaster and TrialOne contract

wins.

July 3 WhaTech article

The global CTMS market is expected to grow 14% annually through 2019 to a $1.8485 billion market. Oracle, Parexel,

Merge and Medidata were cited as the market’s top companies.

“A new market report ‘Clinical Trial Management System Market—Global Industry Analysis, Size, Share, Growth,

Trends and Forecast, 2014–2019,’ the global clinical trial management system market was valued at USD 844.0

million in 2013 and is expected to grow at a CAGR of 14% from 2014 to 2019, to reach an estimated value of USD

1,848.5 million in 2019.”

“Globally, the CTMS market is witnessing significant growth due to increasing R&D investment in pharmaceutical, life

science and clinical research industries. It empowers organizations and research centers to enhance productivity

and effectiveness of clinical trials by advancing and managing clinical trials. Integration of CTMS with HIS provides

more accurate and time saving documentation, and it is also one of the major driving factor for the growth of the

CTMS market.”

“Additionally, increasing prevalence of diseases is supporting clinical trials in different regions, and increased clinical

research outsourcing is playing a major role in the growth of the CTMS market. Presence of various end users such

as pharmaceuticals, clinical research organizations (CRO) and healthcare providers has increased the acceptance of

CTMS.”

“North America is a traditional clinical trial region. The average cost of pharmaceutical research and development for

a successful drug continues to increase from pre-clinical to FDA approval. Clinical trials in the U.S. have been funded

http://www.omnicomm.com/TrialMaster/TrialMaster_the_most_intuitive_electronic_data_capture.html

http://www.omnicomm.com/trialone.html

http://www.whatech.com/members-news/practice-management-software/23259-clinical-trial-management-system-market-is-expected-to-reach-usd-1-848-5-million-in-2019


23


and sponsored by National Institute of Health (NIH), other government agencies, academic groups, voluntary health

organizations and industry. According to the U.S. National Institute of Health (Clinical Trial government registry) in

2011, there were 56,981 clinical trials conducted in the U.S.”

“In Europe, countries in Central and Eastern Europe provide abundant chance to life science companies for clinical

development. According to Oracle Corporation, a CTMS company, the percentage of clinical trials conducted in

Western Europe has decreased from 25% to 19% and in Eastern Europe, the same has increased from 10% to 13%

during 2006-2010.”

“However, Asia is the fastest growing region in the clinical trial management system market. Asia has become one of

the fastest-growing market for pharmaceutical products. Improved industry regulatory laws and patent expiration

laws in various countries including Japan, China and India, have led to the expansion of the clinical trials market in

Asia. Asia has lower cost of conducting clinical trials compared to Europe or the U.S.”

“Oracle Corporation, Parexel, Merge Healthcare and Medidata are the leading companies offering clinical research

services. Other major players of clinical trial management system market include BioClinica, MedNet, eClinforce, Bio-

Optronics, Forte Research and DSG.”

July 7 Wall Street Journal article

OmniComm’s TrialMaster was chosen by a leading biotechnology company for three Phase III late-stage studies based on

its user interface, data capture, data management and reporting functionality.

“OmniComm Systems, Inc., a leading global provider of data management solutions for clinical trials, today

announced that a leading biotechnology company, selected OmniComm’s TrialMaster electronic data capture

technology (EDC) to support three Phase III late stage clinical development studies. TrialMaster will be used for an

open-labeled, multicenter, safety study and two randomized, double-blind, placebo-controlled efficacy and safety

studies. OmniComm’s proven technology and processes for integrating TrialMaster with other best-of-breed solutions

was an important factor in selecting TrialMaster as their preferred EDC system. This leading biotechnology company

will integrate TrialMaster with its preferred Interactive Response Technologies (IRT) solution. IRT solutions automate

randomization and clinical supplies management and when integrated with TrialMaster EDC provides a

comprehensive end-to-end solution.”

“TrialMaster’s intuitive user interface and innovative data capture, data management and reporting functionality was

a significant factor in this company’s selection of TrialMaster. TrialMaster also includes embedded eLearning,

allowing researchers to easily learn the system and quickly and accurately initiate new clinical trials.”

June 25 Broadway World article

OmniComm’s TrialOne was selected by a large CRO to standardize processes, improve business intelligence, ensure

regulatory compliance, and achieve overall business transformation across all of its global Phase I clinics.

“OmniComm Systems, Inc., a leading global provider of clinical data management solutions for clinical trials, today

announced that one of the world’s largest contract research organizations selected TrialOne to standardize

processes, improve business intelligence, ensure regulatory compliance, and achieve overall business

transformation across all of its global Phase I clinics.”

“TrialOne is a browser-based bedside data collection technology designed specifically to address the needs of Phase

I clinics. Subject recruitment, study data capture, sample tracking, reporting, data management and integration with

laboratory and medical monitoring equipment are all inherent capabilities of TrialOne that led this CRO to select

TrialOne.”

“Furthermore, TrialOne’s import and export features that provide integration with laboratory information

management systems for lab orders and results processing is another significant feature that drove the selection.”

“TrialOne enables the automation of clinic data collection; standardizes recruiting; facilitates the collection of study

data and sample tracking; reduces discrepancies inherent in paper-based applications; and ensures compliance.”

“‘We are now seeing a major increase in activity in the Phase I clinic automation market and this latest major win for

OmniComm confirms our position as the market leader,’ said Dr Kuno van der Post, senior vice president business

development, OmniComm Systems. ‘The continued adoption of TrialOne by the industry’s largest organizations is a

testament to the high quality of our new technology.’”

http://online.wsj.com/article/PR-CO-20140707-907350.html

http://www.broadwayworld.com/bwwgeeks/article/OmniComm-Systems-Signs-Multi-Year-Agreement-With-Top-5-Global-CRO-for-TrialOne-20140625#.U7wvoIWgWZI


24


Acquisitions These two sources highlighted key acquisitions made by BioClinica and Parexel to expand their portfolio and global presence.

June 17 OutsourcingPharma.com article

BioClinica is acquiring Blueprint Clinical in an effort to address current CTMS trends of risk monitoring and management.

“CRO BioClinica will acquire Blueprint Clinical, which offers a cloud-based site scoring tool to help pharma address

risk-based monitoring strategies for trials.”

July 2 RealWire article

Parexel acquired Atlas Medical Services, which will expand its presence in Turkey, the Middle East and North Africa.

“Parexel International Corporation, a global clinical research organisation, announced today that the Company has

acquired all of the outstanding equity securities of ATLAS Medical Services (‘ATLAS’), a provider of clinical research

services in Turkey, the Middle East, and North Africa.”

“Josef von Rickenbach, Chairman and CEO of Parexel stated, ‘The acquisition of ATLAS strengthens Parexel’s

presence in Turkey, the Middle East and North Africa. These markets are of increasing importance to our clients who

are looking for market access and a broad spectrum of patient populations for clinical trials. In addition, ATLAS has

been a trusted business partner to Parexel for many years, and their infrastructure and staff are already aligned with

our processes and operations. By fully integrating ATLAS into Parexel’s global operations, we will enhance our ability

to help clients more quickly achieve their goals of bringing important therapies to patients not only in Turkey, the

Middle East, and North Africa, but also throughout the rest of the world.’”

Additional research by Linda Richards, Renee Euchner and Carolyn Schwaar

The Author(s) of this research report certify that all of the views expressed in the report accurately reflect their personal views about any and all of the subject securities

and that no part of the Author(s) compensation was, is or will be, directly or indirectly, related to the specific recommendations or views in this report. The Author does not

own securities in any of the aforementioned companies.

OTA Financial Group LP has a membership interest in Blueshift Research LLC. OTA LLC, an SEC registered broker dealer subsidiary of OTA Financial Group LP, has both

market making and proprietary trading operations on several exchanges and alternative trading systems. The affiliated companies of the OTA Financial Group LP, including

OTA LLC, its principals, employees or clients may have an interest in the securities discussed herein, in securities of other issuers in other industries, may provide bids and

offers of the subject companies and may act as principal in connection with such transactions. Craig Gordon, the founder of Blueshift, has an investment in OTA Financial

Group LP.

© 2014 Blueshift Research LLC. All rights reserved. This transmission was produced for the exclusive use of Blueshift Research LLC, and may not be reproduced or relied

upon, in whole or in part, without Blueshift’s written consent. The information herein is not intended to be a complete analysis of every material fact in respect to any

company or industry discussed. Blueshift Research is a trademark owned by Blueshift Research LLC.

http://www.outsourcing-pharma.com/Clinical-Development/BioClinica-taps-risk-based-monitoring-with-Blueprint-Clinical-buy

http://www.realwire.com/releases/PAREXEL-International-Announces-Acquisition-Of-ATLAS-Medical-Services

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