Swimming upstream

Medidata-Fast Track partnership seeks end-to-end trial process efficiencies

Amy Swinderman
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NEW YORK—Seeking to expand its electronic data capture (EDC) and trial management product portfolio and drive efficiencies across the clinical research process, Medidata Solutions announced in mid-March its acquisition of Fast Track Systems Inc., a provider of clinical trial planning software, proprietary contracting data and professional services.

Medidata, which provides clinical researchers in more than 80 countries with protocol design, end-to-end data capture tools and trial contracting and negotiation services, said the acquisition will create upstream efficiencies across the clinical research process and further solidify Medidata's position as leader in EDC technology.

"We have established a reputation for thought leadership in the industry," says Medidata CEO and co-founder Tarek Sherif. "The mission of our company has always been to provide innovative technology to life science organizations. Fast Track has always been focused on clinical design and execution, which really complements our mission of providing sponsors with the most advanced tools for planning and managing clinical trials."

Fast Track has provided its customers—which include 10 of the top 15 pharmaceutical companies—with contract benchmark data and analysis tools to enhance relationships with investigator sites and CROs for more than 16 years. More recently, the company 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 CEO Ed Seguine, who is now Medidata's general manager of trial planning solutions, says the protocol development tool certifies that any data collected is accurate consistent with CDISC standards and is able to be exchanged with another system.

"In order to be able to exchange information, you have to have a standard set of information in the first place," Seguine says. "There are a lot of systems that can interpret information, but there were none in our space that could create it in the first place."
Seguine says the acquisition grew from a February 2007 collaboration in which the two companies integrated Fast Track's protocol development tool with Medidata Rave, Medidata's EDC, management and reporting solution.

"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," Seguine says. "We view this partnership as a continuum of our effort to make upstream improvements in trial planning as well as trial operations."
Medidata's expanded portfolio now also offers protocol development, trial management and finance teams a consistent view of the operational data generated throughout the clinical research process. Medidata Designer, formerly Fast Track TrialSpace Designer XCP, deploys a standardized protocol development methodology that populates a protocol warehouse with consistent study design parameters and facilitates compliance with CDISC data submission standards.

Medidata Grants Manager, formerly Fast Track TrialSpace Grants Manager, is the only clinical cost database derived from negotiated agreements between sponsors and investigators. The Internet-based platform includes data from nearly 250,000 grants and contracts and more than 27,000 protocols in more than 1,400 indications.

Medidata CRO Contractor, formerly Fast Track TrialSpace CROCAS, is an outsource planning and contracting solution that 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.

Sherif says on a stand-alone basis, these products already have had a lot of market traction, but the clinical research community has expressed even more interest in the combined companies' synergies.

"They can see the power of starting the process upstream and being able to populate or configure their educational system with a minimum amount of work," Sherif said. "I think this points to an evolution in our industry. These products will be transformational for the industry and a call to action."

Because Fast Track was a smaller company, it may have experienced difficulty in getting market traction, Sheriff says. Now that New York-based Medidata has assumed operation of Fast Track's offices in Conshohocken, Pa., and Ross, Calif., the combined company now has better leverage with a total of eight offices worldwide.

"We're now about a 600-person, global organization. We have joint visions for where the overall industry needs to go, and there is utility coming right out of the box on this one."

Amy Swinderman

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