BIORESEARCH MONITORING AND MEDICAL DEVICE STUDIESBest Practices in Medical Device Clinical Trials
May 18, 2007
Medical Device Consultants, Inc.
Today’s Topics
Clinical Trial Contracts
Outsourcing to a CRO
Launching Clinical Trials – differences in a small vs large company environment
Overview of the BIMO program at FDA
Inspection Results/Compliance Issues
© Medical Device Consultants, Inc. 2007
Habits of Highly Effective Sponsors
FDA BIMO’s division reviewed sponsor inspection results from October 2003- February 2006
Compiled common traits in cases of good inspection outcomes: NAI
© Medical Device Consultants, Inc. 2007
Five Habits of Highly Effective Sponsors
1. Establish SOPs for
ACRP The Monitor, April, 2007
© Medical Device Consultants, Inc. 2007
Five Habits of Highly Effective Sponsors
2. Hire employees with
© Medical Device Consultants, Inc. 2007
Five Habits of Highly Effective Sponsors
3. Utilize consultants/CRO
© Medical Device Consultants, Inc. 2007
Five Habits of Highly Effective Sponsors
4. Conduct audits of clinical
study processes and
© Medical Device Consultants, Inc. 2007
Five Habits of Highly Effective Sponsors
5. Clinical study progress
© Medical Device Consultants, Inc. 2007
Five Habits of Highly Effective Sponsors
Establish SOPs for clinical study functions
Hire employees with experience in conducting clinical studies
Utilize consultants/CRO
ACRP The Monitor, Marcarelli, April 2007, p 83-84
© Medical Device Consultants, Inc. 2007
Best Practices in Medical Devices Trials
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