By Deborah Borfitz

March 18, 2008 | Medidata Solutions has acquired Fast Track Systems Inc., developer of the first protocol-authoring tool certified by the Clinical Data Interchange Standards Consortium (CDISC), eCliniqua learned during an exclusive interview with company representatives last week. The move will drive efficiencies across the clinical research process and further solidify Medidata’s position as leader in electronic data capture (EDC) technology, says CEO Tarek Sherif.

The acquisition evolved out of a partnership between the companies that started early last year. The two organizations have a lot of “core similarities” in terms of their goals and approaches to improving the conduct of clinical research, says Sherif, including a relentless drive for efficiencies through standardization and innovative technologies. With Fast Track products in its portfolio, Medidata can accomplish that mission more broadly in terms of protocol development and trial planning, contracting, and negotiations.

Fast Track received CDISC certification last year for its first-of-its-kind structured protocol-design tool. Even on a standalone basis, the application – currently in use by several large pharmaceutical companies – “eases the study start-up process,” says Ed Seguine, Medidata’s new general manager of trial planning solutions (previously CEO of Fast Track Systems). The application captures key concepts and the relationships among those concepts – i.e. “the linkage of study objectives to outcomes to specific tasks, variables, and the analyses being performed” – and uses that information to help generate a protocol document.

CDISC certification is important because it allows the outputs to be consumed by other types of information systems, says Seguine. Structured protocol and statistical design information, a key aspect of the FDA’s plans for electronic data submissions, both help clarify the intent of a study and enable better cross-study data comparisons. Developing trial design standards is consequently one of the key goals for CDISC in 2008.

Medidata Designer, as the protocol-authoring tool is now known, standardize the study design process and eliminate errors associated with protocols authored using traditional tools, says Sherif. The next step will be to automatically populate the metadata contained in the protocol into EDC and information systems for interactive voice response and clinical trial management, to streamline and shorten start-up times.

EDC represents a “huge piece” of the workload for conducting clinical studies, but has been missing time- and cost-saving opportunities “upstream…and downstream of that,” says Seguine. In addition to protocol design, Medidata’s newly acquired products focus on other upfront, operational decision-making, such as how to best contract with investigator sites and CROs.

Medidata Designer is “functionally integrated…right out of the gate,” says Sherif. Fast Track’s better-known investigator site contract benchmarking tool (now Medidata Grants Manager) and outsource planning and contracting solution (Medidata CRO Contractor) are already “standard equipment” at many top pharmaceutical companies.

Ultimately, structuring data in the protocol-design phase could lead to simpler studies with fewer procedures. Complex, procedure-heavy studies have recently been demonstrated by the Tufts Center for the Study of Drug Development to negatively impact clinical trial conduct, says Seguine.

“The integration between protocol design, study design, and EDC must become transparent” if EDC is to continue its aggressive rate of adoption, says Chris Connor, senior research analyst, clinical development, at Health Industry Insights. “If not, EDC will simply amplify study design flaws.”

Fast Track is a “pioneer in eClinical CAD [computer-aided design],” adds Connor. “When combined with Medidata Solutions’ ability to construct and execute increasingly complex clinical trials, the sky’s the limit.”

Medidata will continue to operate Fast Track’s offices in Conshohocken, PA, and Ross, CA, bringing Medidata offices to a total of eight worldwide, says Sherif.
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