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E-BOOK

E-BOOK

YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL TRIALS MANAGEMENT appliedclinicaltrialsonline.com

CURRENT PERSPECTIVES

ON

RISK-BASED MONITORING

CO-SPONSORED WITH:

2 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com

E-BOOK

E-BOOK

YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL TRIALS MANAGEMENT appliedclinicaltrialsonline.com

CURRENT PERSPECTIVES

ON

RISK-BASED MONITORING

CO-SPONSORED WITH:

TABLE OF CONTENTS

3 Why Risk-Based Monitoring?

Costs, patient quality, data quality factor

into monitoring decisions.

6 Risks, Signals, and Scoring

What determines risk and how are risk levels determined?

8 Technology Use to Achieve

Risk-Based Monitoring

Where is the technology for RBM exactly and

what should organizations be looking for? CO

VER

DES

IGN

: D

AN

WAR

D

O U R M I S S I O N

Applied Clinical Trials is the authoritative, peer-reviewed resource and thought leader for the global community that designs, initiates, manages, conducts, and monitors clinical trials. Industry professionals learn effective and efficient solutions to strategic and tactical challenges within the tightly regulated, highly competitive pharma ceutical environment.

IntroductionThe development of this eBook came on the heels of Applied Clinical Trials’ last successful eBook, titled Risk-Based Moni-

toring in Clinical Trials. This eBook, Current Perspectives on Risk-Based Monitoring, was developed in conjunction with

SAS, and is based largely on two projects: a custom research survey conducted by a third-party research firm using an

in-depth phone interview of 20 executives, culled from the Applied Clinical Trials audience database, regarding risk-based

monitoring usage and perceptions.

The second project was a December 2013 webcast titled Myths, Models and Momentum: Risk-Bssed Monitoring, which

featured three presentations from industry experts. Andrew Schafer, President, Industry Standard Research, presented

results on its survey and covered the high-level issues regarding risk-based monitoring. Mark Hronec, Director at PwC, pre-

sented on risk-based monitoring from a CRO and sponsor perspective, delving more into the models. Laurie Rose, Principal

Industry Consultant, Health & Life Sciences at SAS, then discussed using more integrated technologies that improve data

quality with less human intervention to gather and report the data information needed for a risk-based monitoring program.

Schafer also wrote a peer-reviewed article earlier this year that went into his research findings more in-depth, which

touched on the concerns and challenges executives have with risk-based monitoring. But in the end, he noted in the article,

“Survey results reinforced that traditional clinical monitoring will not go away. It can’t. Its scope is a critical component to

help ensure squeaky clean data and utmost patient safety.” Yet, according to study results, if sponsors and service provid-

ers are to relieve stubborn industry-wide financial pressures and meet growing industry demands, clinical monitoring must

begin to morph into more of a hybrid model—at least in the later phases of clinical trials. As one respondent aptly put it,

“There is a large area of opportunity to improve how clinical trials are conducted. Hopefully the combination of new tech-

nologies and alternative models can help to improve monitoring and data quality.”

And this eBook will address those concerns, how companies go about applying scores and rating signals in clinical trials,

and how technology is being used now, and how it is envisioned to be used more effectively in the future.

appliedclinicaltrialsonline.com APPLIED CLINICAL TRIALS 3

Why Risk-Based Monitoring?

Biopharmaceutical firms and CROs are feel-

ing the pressure to conduct what has been

touted as more cost effective, risk-based

monitoring of clinical trials. But there are

several roadblocks to using this technique:

• Complexity of managing international sites.

Monitoring multiple international sites is com-

plicated. According to the NIH, 261,000 clinical

studies were registered in August 2013; 44%

were non-US only. Over the average 7-12 year

period of a clinical trial, that means millions

spent on travel and site visits using traditional

monitoring practices.

• Resistance to business process change. Reg-

ulatory authorities are pushing risk-based moni-

toring, but companies are resisting the necessary

business process changes to make that happen.

Global regulatory authorities are suggesting the

move from 100% source data verification (SDV)

to a risk-based approach to monitoring, but there

is not enough evidence of success with this new

method to drive business process change.

• Variability according to clinical trial type.

Monitoring trials varies according to therapeutic

area, site selection, and trial stage. The bigger

and more complex the trial, the more likely the

failure rate.

Whether these roadblocks are myths or fact,

they remain perceptions uncovered in a group

of in-depth telephone interviews of 20 execu-

tives representing both CROs and sponsors,

conducted by SAS with Applied Clinical Trials, in

October 2013.

There are three central objectives in clinical

trials that pertain to risk-based monitoring: en-

suring patient safety throughout the trial, ob-

taining the highest quality data, and from a cost

perspective, conducting the trial at the lowest

cost without compromising patient safety and

data quality.

But what is risk-based monitoring? In Figure

2, which Mark Hronec, Director of PriceWater-

houseCoopers, shared during a December 2013

webinar sponsored by SAS and Applied Clinical Tri-

als titled “Myths, Models and Momentum: Risk-

Based Monitoring,” the four types of risk-based

monitoring strategies are described. The first is

around reduced monitoring, where organizations

conduct less than 100% source document veri-

fication (SDV). Targeted monitoring is based on

particular triggers that could happen during the

study that would trigger a site visit. Centralized

monitoring is using algorithms or predictive ana-

Costs, patient safety, and data quality factor into monitoring decisions.

Characteristics of Companies On-Site Monitoring Trials

Larger companies with larger budgets

Larger companies with rigid SOPs

Early phase trials

Small trials

Limited sites

Therapeutic area/High level of expertise

Trial plan established with CRO

Source: SAS, Applied Clinical Trials Risk-Based Monitoring, October 2013


lytics to determine the level and type

of monitoring that occurs in a trial.

And the final piece is remote moni-

toring, where monitoring is achieved

either off site and/or potentially in a

different country.

Taken together and implemented

holistically on a study or in a company,

the determination of which sites would

require an increase in monitoring re-

sources—or potentially decreases—is

based on the risk-based approach. By

focusing resources to the sites in need,

the risk-based approach then is in-

creasing the patient safety and data

quality coming from those sites, rather

than having those resources focused

on sites that do not necessarily need

the extra attention, explained Hronec.

Laurie Rose, Principal Industry Con-

sultant Health & Life Sciences at SAS,

agreed during the webinar, and stated

that another misconception is that

RBM means moving completely away

from onsite monitoring. “But in reality,

at least for the near future, it’s more a

matter of optimizing the activities of

monitoring where only essential on-

site visits are required, and then put-

ting technology in place for the more

advantageous, analytical monitoring

of data.”

According to the SAS research, re-

spondents believe that 30% of clini-

cal trial costs are attributed to on-site

monitoring. Reducing these costs, as

noted above, is a key driver for the in-

terest in risk-based monitoring.

However, behind the cost drivers,

there are challenges around the adop-

tion of risk-based strategies. While 80%

of the survey partcipants responded

that they do take a triggered or targeted

approach to risk-based monitoring, 80%

also said that they desired 100% SDV in

100% of trial participant records. Further, 55% said that they

use risk-based monitoring in their organizations and 80%

said centralized monitoring is attractive but slow on the up-

take in their organization.

These discussions, while not statistically high, are in-

dicative to the level of understanding of risk-based moni-

toring in the clinical trials industry. Basically, if your com-

pany is currently applying triggers or targets for site visit

requirements, your company is doing risk-based monitor-

ing, as per the PwC descriptive table.

And while these respondents also stated a 100% SDV

preference, that may not be the key to quality data. Rose

said, “Another area very common to traditional organiza-

tions where they have concerns is that if you move away

from 100% source data verification, then you might risk

patient safety and data integrity. But, in fact, there’s al-


Figure 1.

Source: PriceWaterhouseCoopers (PwC), August 2013

Figure 2.

No

Yes

Risk-based monitoring

Reduced monitoring

Targetedmonitoring

Centralizedmonitoring

Remotemonitoring

Data-driven oversight is tailored to the speci�c studyrisk areas, and the monitoring approaches arecontinuously updated via robust data analysis.

Monitoring at less than 100% SDV depending on studyand site risk

Monitoring based on triggers and predeterminedassessments across sites

Transfer of monitoring activities to low-cost countries,reducing the need for high-cost resources

• Algorithm-based study risk assessment following customized parameters for each study• Automated and nonautomated intervention based on statistical data review

Do You Use Risk-Based Monitoring in Your Organization?

Four Strategies of Risk-Based Monitoring


ready evidence from studies by Clinical Trial Transforma-

tion Initiative, other organizations are showing significant

impact by reducing SDV.” She also notes that there are im-

provements in data quality and in capturing patient safety

signals using EDC and through leveraging central statisti-

cal monitoring.

From its survey at Industry Standards Research, Andrew

Schafer, President, reported in the webcast that there are

factors hindering risk-based monitoring. However, they are

not related to the models, but rather related to the industry

and sponsor-based reasons. These reasons include a lack

of strong regulatory guidance; models being too new and

unproven; general corporate inertia; being risk averse; and

averse to trying new techniques.

Behind the CostsThat being said, cost was found to be the major driver for

conducting risk-based monitoring studies, according to

ISR’s research. In the webinar panel discussion regard-

ing costs, Rose said, “A lot of costs [are] from the clinical

research associates, whether it’s travel or training. And

sometimes with high turnover rates, retraining or having

to re-recruit and retrain. So with a more central remote

modeling, there are some upfront investments; and there

are going to be business process changes within the orga-

nization. There are very likely going to be some software

investments so that they are better improving the data

capture at the site.”

Rose said these upfront costs, however, will also lead to

a cost reduction over time, by having better upfront iden-

tification of risk and trial performance expectations. “That

can reduce a lot of the costs in the operations along the

way. Things like faster recognition of patient safety, and

protocol compliance, and data integrity issues, all of those

will allow for some optimization of the trial.” Hronec men-

tioned, many companies are doing pilots and still trying to

figure risk-based monitoring out. Which includes exactly

where they will get cost savings to then build that into the

organization. He said, “Right now it’s in the early stages;

but over the next several years, we’ll be able to see those

savings throughout the studies.”

Schafer concluded by saying that the momentum of risk-

based monitoring is at a fairly good clip within the organi-

zations they surveyed. Comparing to other studies that ISR

has conducted, the momentum with risk-based monitoring

is higher and more favorable than ePRO technology adop-

tion, or even adaptive trial design. Schafer said, “Risk-based

monitoring isn’t going anywhere and seems to be going to

increase in momentum within the sponsor organizations.”

As revealed by the SAS research, companies are at differ-

ent stages of development for risk-based monitoring. Com-

panies realize they need to have more efficiently executed

trials and risk-based monitoring can help them get there.

With streamlined clinical trial operations, a more pa-

tient-centric approach is enabled. Patient data contains

enormous amounts of information. “We have to change the

way patients are being treated within the system so we can

design protocols that will actually fit the patient,” said an

executive director of a CRO.

When that happens, clinical trials will be truly adap-

tive. They will go beyond collecting data to meet a spe-

cific endpoint. Instead, studies will have quality inherent

in their design, their execution will be optimized, and

they will drive the development of successful new thera-

pies. The risks are simply too great for not doing risk-

based monitoring.

The SAS survey also found the legion of respondents strictly adhering to the final FDA Guidance Oversight of Clinical Investigations —A Risk-Based Approach to Monitoring issued in August 2013. However, they also noted they find the guidance lacking in detail or insight into cutting edge technologies. Rose noted during the webinar that RBM is not required by regulators. What is required is the monitoring of the progress and conduct of the trial. Rose said, “The risk-based approach is being suggested as a way to become more efficient in clinical trial operations. And like in other areas, regula-tors are encouraging innovation with technology and analytics to help improve these processes.”

A Note on Regulation

Upfront costs, however, will also lead to a cost reduction over time, by having better upfront identification of risk and trial performance expectations.


Risks, Signals, and Scoring

Whichever risk-based monitoring type a

company uses for data-driven oversight,

a set of metrics, signals and levels of

scoring risk is necessary to determine

the monitoring plan. According to the

SAS custom research project, many metrics and

signals were used to identify, track, and under-

stand the impact of trial characteristics. The

most significant of these were identified as que-

ries being issued at particular sites, EDC discrep-

ancies, patient risk, and regulatory risk.

Then the respondents identified measures or

signals that would be used during an on-going

trial to adjust or respond to the performance of

a risk-based monitoring plan. These included

work level readjustment, missed data points, data

quality, data quantity, and number of queries.

Across the board, the SAS research respon-

dents determined what would trigger a site-

monitoring visit. These included: sites reporting

a problematic issue with the trial; a centrally

identified problematic trend in reporting; com-

plexity of the trial; delayed recruitment; adverse

events; case report forms needing to be moni-

tored/not being filed for new enrollees; lack

of communication by site; increases in enroll-

ment; and on-site monitor reporting need for

increased future monitoring. One director at a

CRO noted, “We don’t have a formal process to

initiate a site visit. When the monitor is seeing

issues and questions coming from a site and we

start seeing a gap in training or issues that oc-

cur repeatedly.”

The SAS research also concluded that when

serious things go wrong with a trial, such as an

adverse event or an incident report is filed, it is

easy for the respondents to identify issues; how-

ever, unanticipated and less obvious situations

can happen throughout the trial and put it at

risk. These events should be identified as real-

time as possible so that changes can be made

as quickly as possible to help respondents stay

on top of these issues.

Mark Hronec, Director of PriceWaterhouse-

Coopers, noted during a December 2013 webinar

sponsored by SAS and Applied Clinical Trials titled

“Myths, Models and Momentum: Risk-Based

Monitoring,” this exact situation. He termed

them traditional and non-traditional risk factors.

What determines risk, and how are risk levels determined?


Figure 1.

Dynamic site-monitoring

Static site-monitoring

Site Monitoring Schedules


Along the traditional were those previously mentioned—

recruitment rates, protocol deviations, serious adverse

events, the drug safety profile or the site location or expe-

rience at the site. However, those non-traditional risks that

could be identified and leveraged using real-time “big data”

predictors included average patient visit window deviation,

the number of visits the site has per day, the number of

inclusion or exclusion criteria, and the length of the in-

formed consent form, among others.

Hronec also said that the traditional and non-traditional

risk factors are further framed under three categories—pro-

tocol risk, study site risk, and dynamic risk.

For example, protocol risks include the therapeutic area,

drug safety profiles, etc. But also aspects around the number

of inclusion/exclusion criteria, the number of procedural vis-

its, etc., can be made to complete this profile of protocol risk.

For the sites, the number of universities per square mile

near the site, the physician density, etc. can be examined.

And for the dynamic risks, the number of visits per day can

be a potential risk indicator.

Looking at these non-traditional factors, the potential

relationships can help inform the riskiness of the site, the

protocol, and then the overall study.

Many questions in the webinar were centered on risk-

determinations. Laurie Rose, Principal Industry Consultant,

Health & Life Sciences at SAS, recommended using histori-

cal data, information on past site performance; country and

regional information and statistics; sites that perform bet-

ter with recruitment, enrollment, and actual study startup.

“[With those data, you are] using a predictive model rather

than just summarizing and putting them all together. Using

a predictive model can help determine a better set of ex-

pectations of what might come in the future.”

Rose also noted other predictive data would include in-

formation within the same therapeutic area or other similar

compounds from past studies and using that understanding

in future studies. Where data is available, the analysis will be

helpful in preparing for the next study.

Who actually determines risk assessment in the organiza-

tion? According to the experts on the webinar, risk should

be determined in a cross-departmental way that includes

the physician, clinical operations lead, a statistician, data

manager, etc. Hronec said, “It depends on whether or not

the organization is doing this as a point-by-point solution,

in which case you would mostly have that centralized within

the study team. But if the organization wanted to take this

on holistically, then you really look at how do we categorize

the risk levels of allergy studies versus oncology studies?

And with those types of conversations, those need to be

escalated within the organization and include drug safety

representatives as well.”

Another point that Rose brought up is risk “re-use” in stud-

ies. Risks will not be the same for every trial, but a number

of studies will have similar rules and certain set thresholds.

“There might be some of those that are common and can be

used each time, but there will be others that will be specific

to the protocol or to the therapeutic area that the medical

personnel need to have influence on how those might change

from study to study.”

The upfront understanding and measuring of risk to suit-

ably determine the monitoring plan, as well as early discus-

sion with regulatory authorities about the monitoring plan,

can impact timelines. Andrew Schafer, President of Industry

Standard Research, noted in the webinar, “If you have not

really planned ahead, it can elongate study startup and, in

fact, the entire study timeline.” He continued, “From our

respondents, most people believe that that upfront time

is worth it to conduct the risk-based monitoring study; but

you just have to account for it.”


Figure 2.

0 10 20 30 40 50 60 70 80 90 100

No

Yes

Do You Use Triggers and Risks to Determine a Site Monitoring Visit?

Source: SAS, Applied Clinical Trials webcast, December 2013 www.appliedclinicaltrialsonline.com/monitoring

Figure 3.

0 5 10 15 20 25 30

(during study) Early signaling of site compliance to the protocol, GCP compliance

(during study) Early signaling of study risks and trends, potential protocol adjustments can be identi�ed

(during study) Early signaling of under-reporting

(pre-study start) Identify parts of the protocol according to their risk pro�le and implement mitigation strategies

(pre-study start) Identify sites with quality risks and implement mitigation strategies

19.4%

25%

0.9%

25%

29.6%

Of the Following Benefits from RBM Technology, Which is the Most Important?

See how leading firms are optimizing

risk-based monitoring.

AnalyticsIf risk-based monitoring is the silver bullet to more quickly developing safe and effective products at lower costs, how are life science organizations approaching this critical need? Learn about the barriers and rewards to risk-based monitoring, get suggestions for moving forward, and see what the ideal system looks like.

SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies. © 2014 SAS Institute Inc. All rights reserved. S119211US.0114

Read the report

http://www.sas.com/en_us/offers/13q3/2280637-Risk-Based-Monitoring-Special-Report/register.html


Technology Used to Achieve Risk-Based Monitoring

A SAS custom research project determined

that organizations currently using risk-

based monitoring are receiving benefits,

and are focused on at least meeting or

exceeding the benefits of on-site visits.

These organizations intend to continue imple-

menting innovative, technologically savvy, risk-

based monitoring plans that will allow them to

cut costs, improve quality, and meet regulatory

requirements while putting patient safety first.

The respondents also said they hope to

achieve the following benefits in that exercise:

identifying what is key in data collection/inte-

gration; the ability to focus resources on high-

est-need sites; reduction in site fatigue; empow-

ering adaptive studies; better patient outcomes;

and increasing understanding and integration of

global data.

As was observed in the previous articles in

this eBook, upfront technology costs will be

necessary, and the need to pull data into pre-

dictive tools is key to the risk-based monitoring

profile. But what technologies are companies

currently using to achieve risk-based monitor-

ing? According to the SAS research, many were

using proprietary applications, EDC platforms,

CTMS, and IVRS; and many sponsor organiza-

tions were looking to rely on their CRO systems

for these needs. And from the custom research,

it appears that CROs are ahead of biopharma

companies in using technology, while smaller

biopharma companies lack the resources to

keep up. “We do remote monitoring via EDC,”

said the data operations leader of one CRO. An-

other firm reported it mixes hard copy and elec-

tronic reports. “We have regular reporting from

the CRO, after a dosing schedule and interim re-

ports and final reports. We use both electronic

and hard copy to evauate and review,” said the

CEO of a biopharmaceutical company.

“We establish the site in advance, and I re-

view the sites and audit the sites in person,” re-

sponded the CEO of a biopharmaceutical com-

pany. “Then we do the study. It is fixed once we

establish this.” In a separate survey by Applied

Where is the technology for RBM and how do companies get to next stage predictive analytics?


Figure 1.

No

Yes

Are You Considering a Centralized Monitoring Strategy?


Clinical Trials, conducted in October

2013, 36% of the respondents said they

are looking to purchase technology to

support risk-based monitoring within

the next two years.

Centralized MonitoringCentralized monitoring is one risk-

based monitoring strategy that is

benefitted by a healthy dose of tech-

nology investment. The majority of re-

spondents in the SAS custom research

project said that while they want to

increase centralized monitoring, they

don’t have strategic plans in place to

take them there. Instead, they are still

relying on static schedules for on-site

monitoring. But using technology for

centralized, risk-based monitoring and

predictive analytics, as defined by reg-

ulatory guidelines, is well documented

in the industry.

While the respondents of the SAS

research project noted a lack of speci-

ficity in the FDA Guidance, the docu-

ments does state: “FDA encourages

greater use of centralized monitoring

practices, where appropriate, than has been the case his-

torically, with correspondingly less emphasis on on-site

monitoring.” Again, not specific what types of electronic

systems should be used, however, the FDA recommends

that sponsors who plan to incorporate centralized moni-

toring, “should ensure that the processes and expecta-

tions for site record keeping, data entry, and reporting

are well-defined and ensure timely access to clinical trial

data and supporting documentation.”

While firms would like to move toward technologically-

driven, centralized risk-based monitoring; they are only

taking baby steps. “Risk-based is the only way,” said the

clinical development group leader of a CRO. And the chief

scientific officer of a CRO added: “Everybody is going to

go risk-based with less frequent monitoring. Due to tech-

nology, the information is available in most systems.”

What Technology for RBM?The key for risk-based monitoring, from an information

management perspective, is to bring together both clini-

cal data from past studies, as well as the operational data,

especially site performance, to use in assessing risk for new

studies, said Laurie Rose Principal Industry Consultant,

Health & Life Sciences at SAS, during a webinar sponsored

by SAS and Applied Clinical Trials titled Myths, Models and

Momentum: Risk-Based Monitoring. “Those historical data

sources enable views of the past studies that can be ana-

lyzed to help set a baseline for what to expect in similar new

studies. Once the new study is established, incoming data is

also prepared for views and risk analysis by country or thera-

peutic area, site, investigator, CRA, or any other preferred

hierarchy.”

But where is the technology for RBM exactly and what

should organizations be looking for? Rose said that one

myth is that there’s really no proven RBM technology.

While she conceded it may not be a complete myth, she

did note a number of pilots where results are being pub-

lished, including a joint project in the UK by the Medical

Research Council, Department of Health, and the Medi-

cines in Healthcare Regulatory Agency, published in 2011.

In addition, the TransCelerate BioPharma consortium of

19 pharmaceutical companies that have been sharing and

presenting best practices on a number of initiatives, in-

cluding Risk-Based Monitoring. Said Rose, “TransCelerate

as a whole has been sharing methodology and analytical

Source: SAS, Applied Clinical Trials webcast, December 2013 www.appliedclinicaltrialsonline.com/monitoring

Figure 2.

Risk Identi�cation & Assessment

Study Data

RiskBusinessRules

Risk /PredictiveModeling

Assess &Score

Monitor &Report

Risk Identification and Assessment

“Everybody is going to go risk-based with less frequent monitoring. Due to technology, the information is available in most systems.”


techniques that leverage technology to innovate these

processes.”

The TransCelerate methodology does not suggest spe-

cific technologies or solutions that are offered by tech-

nology vendors in its current paper. It does list a Systems

Requirements and Preferred System Attributes, under

categories including Planning, Data Capture, Data Ag-

gregation, Analytics, Reporting and Visualization, and

Miscellaneous.

But for Analytics, TransCelerate says that those pre-

ferred system attributes include the following abilities:

• apply analytics to aggregated data (virtually or

actual) in order to identify outliers, trends

• apply thresholds relative to outliers; pre-

fer dynamic threshold definition

• indicate potential quality risk

• automated reporting

Rose described the components that SAS believes will

take shape in risk-based monitoring technology decisions

and strategies in the near future. “The technology ap-

proach starts with information management. It is the criti-

cal first step that pulls together essential data sources and

provides a view across sites, investigators, countries, mon-

itors, and patients. And then using analytics to assess the

risk elements of the trial and managing those risks, those

will make up core components for moving to a more risk-

based approach and having the ability to mitigate risks

that are discovered through this more central approach to

monitoring.”

It is in the analytical exercise that additional factors

from historical data would be leveraged--from what did

happen—to look more into the future for what is the po-

tential of something happening. Said Rose, “A particular

area that it’s going to be useful in is with adverse events

or serious adverse events where a predictive model is go-

ing to spot a trend where adverse events might only be

showing up in a couple of sites, not all sites. But in those

unique sites that have some outliers, there might be simi-

lar characteristics of the types of patients; and you’re just

not going to find that in the traditional monitoring where

you’re looking at that data one site at a time. But when you

have the ability to look all the way across, use more pre-

dictive models to look at trends, then you can start seeing

things like safety signals with patients much sooner.”

Data Aggregation in PracticeThe processes that need to take place after the data

sources are identified are filtering and aggregating to de-

termine which data elements make sense to use in assess-

ing the risk, and automating the data collection and the

refresh process, explained Rose. “Depending on the stage

of the trial or even the type of the study, that refresh and

update of the data might vary from near-real time updates

to daily, weekly, or monthly summaries. The data can also

be refreshed in a way that can support cumulative analysis,

as well as just a snapshot as both of those may help re-

flect different types of risk.”

During the webinar presentation and the Q&A, the inher-

ent challenge of disparate data sources was noted, as well

as preparing the data for advanced analytics, which drives

the risk assessment and the scoring process.

The audience wondered how industry could manage

the aggregation of data when multiple providers are being

utilized in outsourced functional service provider models.

Rose admitted that it is a challenge, but that it would be

true with any data aggregation issues with different pro-

viders and different systems, and it was not specific to

risk-based monitoring technologies.

However, Rose advised that a plan for that aggregation

of that data be in place, especially on the provider’s side.

“For a sponsor who might have multiple providers, from a

pure data integration and from a technological perspec-

tive, there are information management systems available

that can gather data from any type of a data source and

bring that together. I know from a clinical data perspective,

it would be very helpful to have CDISC standard formatted

data, which most of the EDC systems are using.”

Not minimizing the challenge, Rose said how orga-

nizations are going to bring the data together and what

data they will use to run that monitoring process from a

more centralized approach, is something that needs to

be determined when making their risk management plans.

She noted, “Innovative technology will enable improved

processes for collecting and analyzing data centrally,

across an entire study, so that both central risk monitor-

ing groups and on-site monitors will have improved insight

into clinical studies.”

During the presentation and the Q&A, the inherent challenge of disparate data sources was noted, as well as preparing the data for advanced analytics.

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