Electronic data capture (EDC) specialist Medidata Solutions has widened its palette with technologies to drive efficiencies in protocol development and clinical trial planning, contracting and negotiation by acquiring fellow US company Fast Track Systems.

Based in Conshohocken, Pennsylvania, Fast Track is a provider of clinical trial planning software, proprietary contracting data and professional services that counts 10 of the top 15 pharmaceutical companies among its customer base.

Trial sponsors have been using Fast Track’s contract benchmark data and analysis tools to enhance their relationships with investigator sites and contract research organisations (CROs) for more than 16 years, Medidata noted.

More recently, Fast Track developed TrialSpace Designer XCP (now known as Medidata Designer), a protocol authoring and trial design tool that helps guide clinical research teams through the protocol creation and study set-up process. As Medidata points out, this was the first commercial tool of its kind to be certified by the Clinical Data Interchange Standards Consortium (CDISC).

It also quotes Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development, as saying that – according to the Center’s research – protocol design is “the lynchpin for streamlining downstream clinical research processes and improving drug development performance”.

Two other trial management tools acquired by Medidata with Fast Track Systems are Fast Track TrialSpace Grants (now Medidata Grants Manager) and Fast Track TrialSpace CROCAS (renamed to Medidata CRO Contractor).

The first of these is an investigator site contract benchmarking tool that helps trial managers optimise investigator grants by ensuring fair and consistent site payments and mitigating compliance risks. The internet-based platform includes data on nearly one quarter of a million grants and contracts, and on more than 27,000 trial protocols in over 1,400 indications.

Medidata CRO Contractor is an outsource planning and contracting solution that puts data-driven analytical tools in the hands of research sponsors, so they can optimally plan, budget for and manage CRO relationships. The software offers up-to-date information on more than 4,000 sponsor contracts with over 250 global CROs in an internet-accessible, easy-to-use workspace, Medidata says.

A partnership that grew
No financial details were given on the acquisition, which grew out of a partnership formed by Medidata and Fast Track in February 2007 to integrate Fast Track’s protocol development tool with the electronic data capture, management and reporting solution Medidata Rave.

“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,” commented Ed Seguine, former chief executive officer and now 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,” he added. “As a combined company, we are able to help customers and partners realise greater value from their eClinical strategy by putting innovative technology and insightful data into researchers’ hands to facilitate their decision-making.”

Other members of the Fast Track executive management, including chief technical officer Peter Abramowitsch and vice-president of operations Lori Shields, have joined Medidata’s management team with a focus on trial protocol design, contracting and negotiation. Medidata is also retaining Fast Track’s offices in Conshohocken and in Ross, California.

“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, Medidata CEO and co-founder. “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.”