Contract Research Organisation Medical and Pharmaceutical
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Contract Research Organisation Medical and Pharmaceutical Projects
Transcript of Contract Research Organisation Medical and Pharmaceutical
Contract Research Organisation Medical and Pharmaceutical Projects
Quality by design
For nearly 20 years CROMSOURCE has been trusted by the pharmaceutical, biotechnology, vaccine and medical device industries to deliver their clinical trials and resolve their staffing requirements. Reputed for its customer focus, flexible approach and strong project management, CROMSOURCE receives an 80% level of repeat business.
Established in 1994, CROMSOURCE began
working not only in Western Europe, but
also in the Central and Eastern European
regions, Russia and Ukraine. The depth
of our experience (over 15 years) in
these regions provides our clients with
a key advantage when including these
important areas in their clinical development
programmes. In this time CROMSOURCE
has worked across a broad range of
therapeutic areas and all phases of research.
CROMSOURCE has notable experience in
medical device trials, having conducted a
large number of clinical investigations for a
range of CAT II and CAT III devices.
Whilst CROMSOURCE routinely works
with many of the largest global life
science companies, the company remains
a mid-sized organisation and offers an
adaptable structure to its customers, who
quickly establish direct contacts with their
project team and senior management. This
approach is appreciated particularly by our
clients in the biotechnology and mid-sized
pharmaceutical sectors.
The CROMSOURCE approach is ‘Quality
by Design’ – our focus on ensuring all
aspects of operations are closely managed,
including those of each single project, with
a view to proactively identify and prevent
quality issues and operational threats
rather than relying solely on the ability to
react when they arise. Quality assurance is
guaranteed through the integrated, certified
quality system ISO 9001 first achieved nearly
10 years ago. You can be assured that
CROMSOURCE provides both high quality
data and a high quality service.
Expertise you can rely on
CROMSOURCE has successfully delivered hundreds of projects to sponsors of every size in both the biopharmaceutical and medical device industries.
CROMSOURCE has worked in many
therapeutic areas and in all phases of
clinical research. Operating across Western,
Central and Eastern regions of Europe,
Russia, Ukraine and the USA, we offer our
customers access to rapidly enrolling, high
quality research sites and to prestigious
investigators in all regions. Perhaps the
greatest testament to the CROMSOURCE
focus on quality and exceeding our
customers’ expectations is our steady
growth and high levels of repeat business
and our involvement in rescuing projects.
“With the Feasibility Plus report delivered free and without obligation and the One Trial One Price guarantee it certainly makes sense to invite CROMSOURCE to provide a proposal...”
CROMSOURCE is an ISO certified, full-
service Contract Research Organization
providing clinical trial services and staffing
solutions since 1994. Our team of over 400
clinical research professionals deliver clinical
trials across Europe, Russia, Ukraine and the
USA. CROMSOURCE provides a fixed price
guarantee (One Trial One Price) and adds
value with the highly detailed feasibility
assessment delivered free and without
obligation.
Discover how our philosophy of “Quality by
Design” can contribute to your success!
Why choose CROMSOURCE?
CROMSOURCE is proud to present
Feasibility Plus: an extremely detailed
feasibility analysis for your clinical
trial conducted by our dedicated
Feasibility team. Feasibility Plus
involves direct contact with potential
investigators in all countries under
consideration.
Feasibility Plus provides sponsors with
a comprehensive report that details the
suitability of the protocol design for
implementation by research sites as a
whole and in each individual country.
Of course, Feasibility Plus also provides
accurate country and site selection data,
insight into regulatory requirements,
assessment of the impact of competitive
trials and risk/mitigation strategy coupled
with precise budget and timeline
forecasts. Feasibility Plus is provided free
and without obligation at the proposal
stage. It is part of our commitment to
provide accurate information and added
value to our existing and potential clients.
FEASIBILITY PLUS
ONE TRIAL ONE PRICE
TOTAL TRIAL VIEW
QUALITY BY DESIGN
ADAPTIVE CLINICAL MANAGEMENT
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EXPERT TRIAL RESCUETM
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CROMSOURCE Headquarters:Via Scuderlando, 10 37135 Verona - Italy
Phone +39 045 8222811 Fax +39 045 8222812
email [email protected]
www.cromsource.com
In our view sponsors should be able
to rely on CRO cost proposals, and
should not be subject to numerous
change orders after contracts are
signed. As experts in the organisation,
management and delivery of clinical
research, CROMSOURCE offers One
Trial One Price.
Put simply, One Trial One Price is our
unique pledge that the price agreed
at contract signature is the only price
that the Sponsor will pay. In this way,
CROMSOURCE provides our clients with a
concrete budget which contrasts markedly
with the change order culture prevalent in
today’s CRO industry. It is the embodiment
of the CROMSOURCE commitment to
deliver high quality data to our clients on
time and on budget.
FEASIBILITY PLUS
ONE TRIAL ONE PRICE
TOTAL TRIAL VIEW
QUALITY BY DESIGN
ADAPTIVE CLINICAL MANAGEMENT
TM
EXPERT TRIAL RESCUETM
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CROMSOURCE Headquarters:Via Scuderlando, 10 37135 Verona - Italy
Phone +39 045 8222811 Fax +39 045 8222812
email [email protected]
www.cromsource.com
Make better decisions sooner
Typically, several separate electronic databases are involved in a typical clinical research project (EDC, CTMS, IxRS, ePRO, Drug Storage, Laboratory, Imaging etc) which makes a 360° vision of the trial data difficult. The CROMSOURCE solution is Total Trial View.
This highly efficient technology platform
(ClinTrack®) is delivered from a secure central
hosting centre and integrates all databases
allowing the Sponsor and CROMSOURCE to
access real time information and implement
customisable reports across all the data.
Through Total Trial View, CROMSOURCE
implements Adaptive Clinical Management
of each study. This approach increases
efficiency by ensuring that each site receives
the optimal level of resource and support.
Additionally, because data is available in
real time, study wide and local issues can
be identified sooner, best practice is shared
and action plans can be implemented
more quickly.
By supporting the efficient delivery of high
quality data on time and on budget, Total
Trial View is central to the CROMSOURCE
philosophy of Quality by Design. Please
contact us to find out more.
FEASIBILITY PLUS
ONE TRIAL ONE PRICE
TOTAL TRIAL VIEW
QUALITY BY DESIGN
ADAPTIVE CLINICAL MANAGEMENT
TM
EXPERT TRIAL RESCUETM
TM
TM
TM
TM
CROMSOURCE Headquarters:Via Scuderlando, 10 37135 Verona - Italy
Phone +39 045 8222811 Fax +39 045 8222812
email [email protected]
www.cromsource.com
Flexible Staffing Solutions
CROMSOURCE continues to lead the
way in providing flexible staffing
solutions. With nearly 20 years
experience of providing high quality
clinical research professionals, we
are able to add real value to your
important research programmes by
allowing you to efficiently adjust
the size of your team to peaks
in workload.
We are equally comfortable acting in a
functional service provider setting or in
simply providing short and long term or
permanent staff for your organisation.
CROMSOURCE is currently providing
Staffing Solutions in over 20 countries
with experts across all phases of research
in virtually every therapy area for
pharmaceutical, vaccine, medical device
and biotech companies.
CROMSOURCE Headquarters:Via Scuderlando, 10 37135 Verona - Italy
Phone +39 045 8222811 Fax +39 045 8222812
email [email protected]
www.cromsource.com
CROMSOURCE are equally proficient
whether providing a single project
manager or an international team of
clinical research associates to work on
either pharmaceutical or medical
device projects.
Importantly, we provide one single point
of contact within CROMSOURCE to each
customer to address all their staffing
needs, from new requirements to financial
and operational management of all
ongoing projects. CROMSOURCE also
provides support for all contracted staff,
including people management, training,
coaching and appraisal meetings.
We look forward to discussing with you
how CROMSOURCE Flexible Staffing
Solutions can support your clinical
research programmes.
Data Management & Biostatistics
Based on our experience from 200+
paper and 50+ EDC (Electronic Data
Capture) studies, the CROMSOURCE
Clinical Data Management,
Biostatistics & Medical Writing teams
provide a wide range of services
supporting your submissions and pre/
post product launch requirements.
Once the design of your clinical trial
is defined, CROMSOURCE will ensure
translation into the appropriate
protocol and data capture possibilities
with valuable input by the medical
writing team.
The same team contributes to the
successful completion of your trial by
authoring the clinical study report,
abstracts, publications or presentations.
CROMSOURCE Headquarters:Via Scuderlando, 10 37135 Verona - Italy
Phone +39 045 8222811 Fax +39 045 8222812
email [email protected]
www.cromsource.com
CROMSOURCE data management
solutions continue to be refined and
integrated with the latest proven
technologies, including EDC and ePRO
to help maintain critical timelines and
ensure data quality and security. The
CROMSOURCE team has successfully
handled paper and EDC studies in all
phases, in many therapeutics areas and
within many technology platforms. Our
in-house platform is Oracle Clinical with
Oracle RDC. We are also experienced in
using other EDC packages according to
Sponsor preference.
We believe that statistical support is
necessary at all stages of a clinical trial
(design, conduct, analysis, and reporting).
The use of up to date statistical methods
coupled with SAS technology can help
in designing trials in the most efficient
way and in obtaining objective, reliable
conclusions as early as it is possible.
CROMSOURCE Headquarters: Via Scuderlando, 10 37135 Verona - Italy
Phone: +39 045 8222811 Fax: +39 045 8222812
email: [email protected]
We have offices in:
Belgium
Germany
Italy
Netherlands
Poland
Russia
Spain
United Kingdom
Ukraine
USA
www.cromsource.com
