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Cetero Research Seminars Provide Insights on Designing Accelerated Proof-of-Concept Studies
Date:4/20/2011

CARY, N.C., April 20, 2011 /PRNewswire/ -- Cetero Research, the leading early-phase contract research organization (CRO), will present a scientific seminar series for pharmaceutical and biotechnology researchers entitled "Practical Insights for Designing and Conducting an Accelerated Proof-of-Concept Program." The seminars, the continuation of a series that occurred in the fall of 2010, will share best practices on how to run successful studies by developing robust protocols, ensuring safety and recruiting effectively for innovative accelerated proof-of-concept study designs. The six-city tour will kick off on April 28 in Bridgewater, NJ.

"Pharmaceutical and biotechnology companies are very interested in the efficiencies that this approach can bring to their early-phase clinical studies. However, there are a number of complexities involved in developing these studies to successfully combine multiple protocols into a single study," said Troy W. McCall, Ph.D., Chief Executive Officer of Cetero Research. "Cetero leadership and independent industry experts will share case studies and best practices."

The scientific sessions will cover three aspects of Accelerated Proof-of-Concept (AcPOC) study design and conduct: protocol development, safety in first-in-human trials and patient recruitment strategies. The seminars will offer real-world advice on creating studies that strike a balance between the strict schedule to which accelerated studies must adhere and the built-in flexibility that these trials require for troubleshooting, efficiency and regulatory approval.

"With the accelerated approach, the protocol must be a living document that can be adjusted as you move through each component of the study. There needs to be flexibility in adapting to feedback from regulators and reactions from participants," sai
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