Medidata Solutions, a global provider of electronic data capture
(EDC), management and reporting solutions, today announced the
completion of its acquisition of Fast Track Systems, Inc., a provider
of clinical trial planning software, proprietary contracting data and
professional services. With this acquisition, Medidata extends its
ability to serve customers throughout the clinical research process
with technologies that improve efficiencies in protocol development
and trial planning, contracting and negotiation.
Fast Track has built a broad customer base, including 10 of the
top 15 pharmaceutical companies, by delivering innovative products
that automate activities across the clinical trial process to drive
efficiency, accuracy and quality. For more than 16 years, sponsors
have utilized Fast Track´s contract benchmark data and analysis tools
to enhance relationships with investigator sites and contract research
organizations (CROs). More recently, the company has developed the
first commercial tool certified by the Clinical Data Interchange
Standards Consortium (CDISC) to bring electronic management to the
protocol development and study start-up process.
"Fast Track´s unique focus on improving clinical trial design and
execution truly complements our mission of providing sponsors with the
most advanced tools for planning and managing clinical trials," said
Tarek Sherif, CEO and co-founder of Medidata Solutions. "As a company,
we will continue to pursue strategic opportunities that allow us to
expand and enhance our offerings in anticipation of our customers´
needs and further compete in a dynamic marketplace."
After a year of continued revenue growth in 2007, Medidata has
diversified its experience and expertise in clinical trial technology
with the addition of Fast Track thought leaders and domain experts in
trial planning and negotiation. Medidata will continue to operate Fast
Track´s offices in Conshohocken, PA (Philadelphia area) and Ross, CA
(San Francisco area), bringing Medidata offices to a total of eight
worldwide. The former Fast Track executive management team, including
CEO Ed Seguine, CTO Peter Abramowitsch and VP of Operations Lori
Shields, have joined Medidata´s management team with a focus on trial
protocol design, contracting and negotiation.
Medidata and Fast Track first collaborated in February 2007 on the
integration of Fast Track´s protocol development tool with Medidata
Rave(R), Medidata´s electronic data capture, management and reporting
solution.
"This acquisition was a natural evolution of our initial
partnership. It became clear early on that not only do our
technologies integrate well, but that the two companies shared similar
goals and approaches to making improvements in the way clinical
research is conducted," said Seguine, Medidata´s new general manager
of trial planning solutions. "Individually, each product in the
Medidata portfolio improves the effectiveness of key trial planning
and execution activities. As a combined company, we are able to help
customers and partners realize greater value from their eClinical
strategy by putting innovative technology and insightful data into
researchers´ hands to facilitate their decision-making."
Reaching More Members of the Clinical Research Team with New
Capabilities
Medidata has built its reputation among investigators and data
managers for streamlining the clinical trial process through Rave´s
easy-to-use data capture, management and reporting capabilities.
Medidata´s expanded product portfolio now also offers protocol
development, trial management and finance teams a consistent view of
the critical operational data generated throughout the clinical trial
execution process.
-- Medidata Designer(TM) (formerly Fast Track TrialSpace Designer
XCP(R)) - This cutting-edge protocol authoring and trial
design tool helps guide clinical research teams through the
protocol creation and study set-up processes. Beginning with
structured protocol development, Medidata Designer can
automatically configure other clinical trial systems - such as
electronic data capture and management, data analysis and
electronic data submissions - ensuring an automated
environment for consistent, shared clinical and operational
requirements. Medidata Designer:
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-- Deploys a standardized protocol development methodology
that assures quality consistency and continuity of trial
protocols to more effectively execute the clinical plan;
-- Retains organizational knowledge and builds company
standards by populating a protocol warehouse with
consistent study design parameters; and
-- Facilitates compliance with CDISC SDTM data submission
standards with the only CDISC-certified protocol authoring
tool.
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-- Medidata Grants Manager(TM) (formerly Fast Track TrialSpace
Grants Manager(R)) - This investigator site contract
benchmarking tool helps trial managers optimize investigator
grants by ensuring fair and consistent site payments and
mitigating compliance risks. The only clinical cost database
derived from negotiated agreements between sponsors and
investigators, Medidata Grants Manager includes data from
nearly one quarter of a million grants and contracts and more
than 27,000 protocols in more than 1,400 indications in an
Internet-based platform that:
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-- Shortens the negotiation cycle and fosters rapid
acceptance and active participation by investigators;
-- Enables sponsors to make better informed and consistent
decisions for controlling clinical investigator costs; and
-- Facilitates strong teamwork with collaborative tools for
review, editing and publishing budgets.
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-- Medidata CRO Contractor(TM) (formerly Fast Track TrialSpace
CROCAS(R)) - This outsource planning and contracting solution
puts data-driven analytic tools in the hands of research
sponsors to optimally plan, budget and manage CRO
relationships. Used by clinical, project management,
contracting and finance professionals worldwide, Medidata CRO
Contractor provides up-to-date data from more than 4,000
sponsor contracts with more than 250 global CROs in an
Internet-accessible, easy-to-use workspace that:
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-- Reduces project delays with up-to-date and relevant
information;
-- Saves trial time and costs by ensuring accurate activity
selection and costing;
-- Speeds the preparation of requests for proposals and
contracts; and
-- Simplifies project start-up, project management and
administrative control.
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"Our research at the Tufts Center indicates that protocol design
is the lynchpin for streamlining downstream clinical research
processes and improving drug development performance," said Ken Getz,
senior research fellow at Tufts Center for the Study of Drug
Development. "Research sponsors and CROs express a strong need for
better protocol development and site management tools. Medidata´s
acquisition of Fast Track Systems promises to help meet this large and
growing need."
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading provider of
clinical trial solutions that enable the world´s most advanced life
science organizations to maximize the value of their clinical research
investments by putting powerful tools into researchers´ hands. A
pioneer since 1999 in innovative technologies for planning and
managing clinical studies - including protocol design; clinical data
capture, management and reporting; and trial contracting and
negotiation - Medidata Solutions and its global network of business
partners address the unique needs of sponsors and sites of all sizes.
With deep expertise in conducting studies across all phases and
therapeutic areas, on six continents and in more than 80 countries,
Medidata Solutions helps clinical researchers reduce trial cycle
times, achieve early visibility to reliable clinical data, and
maintain strict fiscal responsibility, while safely accelerating the
process of bringing life-enhancing treatments to market.
