Medidata Solutions Expands Clinical Trial Technology Offering with Fast Track Systems

NEW YORK, NY - 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, 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 (formerly Fast Track TrialSpace Designer XCP) 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:

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.

Medidata Grants Manager (formerly Fast Track TrialSpace Grants Manager) 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:

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.

Medidata CRO Contractor (formerly Fast Track TrialSpace CROCAS) 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-touse workspace that:

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.

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.

NEWS SOURCE : www.mdsol.com