SOURCE: Fast Track Systems

February 26, 2008 11:21 ET

Fast Track Systems, Inc. Finds Marked Therapeutic Area Differences in Clinical Investigator Payments

Findings Have Important Implications for Compliance With Regulatory Guidance Regarding Fair Market Value

CONSHOHOCKEN, PA--(Marketwire - February 26, 2008) - With greater scrutiny from government regulators, diverse product pipelines, and increasingly globalized clinical operations industry sponsors of clinical research face increasing challenges to determine appropriate payments for clinical research services.

An in-depth analysis of investigator grants in the PICAS® database finds that the cost per patient expense for conducting clinical trials varies dramatically across therapeutic areas -- by more than double the cost in some cases.

"The data indicate that the complexity of the trial protocol, the development phase, and the geographic location of the trial all correlate meaningfully with the cost per patient," observed Dr. Fred Cohen, Vice President - Clinical Strategy at Fast Track Systems. Dr. Cohen further commented, "Interestingly, and somewhat surprisingly, these correlations with cost appear to differ between drug and device studies."

"Few, if any, research sponsors possess sufficient contemporary data of their own spanning all therapeutic areas, phases, and geographies to make reliable and defensible Fair Market Value (FMV) determinations," remarked Frank Cattie - Vice President of Sales at Fast Track Systems. "Based on these findings, it seems not only prudent, but mandatory, to use cross-industry payment benchmarks to determine the FMV of clinical research services."

ABOUT FAST TRACK SYSTEMS, INC. - Fast Track Systems provides industry benchmark data and technology to pharmaceutical, biopharmaceutical and medical device companies conducting clinical research worldwide. Its products have shown to reduce cost and improve productivity in the development of compliant agreements with clinical investigators. TrialSpace Grants Manager® - the PICAS® database, draws from over 25,000 finalized protocols and over 250,000 negotiated clinical investigator contracts/grants to ensure that subscribers understand the true cost and compliance consequences when negotiating clinical agreements. For more information, visit