Best Practices in Medical Device Clinical Trials - PowerPoint PPT Presentation

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Best Practices in Medical Device Clinical Trials

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  1. Best Practices in Medical Device Clinical Trials May 18, 2007 Susan M. Rockwell, Manager, Clinical Trials and Clinical DevelopmentMedical Device Consultants, Inc.

  2. 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

  3. 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

  4. Five Habits of Highly Effective Sponsors 1. Establish SOPs for clinical study functions ACRP The Monitor, Marcarelli, April 2007, p 83-84 ACRP The Monitor, April, 2007

  5. Five Habits of Highly Effective Sponsors 2. Hire employees with experience in conducting clinical studies ACRP The Monitor, Marcarelli, April 2007, p 83-84

  6. Five Habits of Highly Effective Sponsors 3. Utilize consultants/CRO for study functions beyond the sponsor’s in-house capabilities ACRP The Monitor, Marcarelli, April 2007, p 83-84

  7. Five Habits of Highly Effective Sponsors 4. Conduct audits of clinical study processes and procedures: • internal and external ACRP The Monitor, Marcarelli, April 2007, p 83-84

  8. Five Habits of Highly Effective Sponsors 5. Clinical study progress reviewed by executive management ACRP The Monitor, Marcarelli, April 2007, p 83-84

  9. Five Habits of Highly Effective Sponsors Establish SOPs for clinical study functions Hire employees with experience in conducting clinical studies Utilize consultants/CRO Conduct audits of clinical processes and procedures Clinical study progress reviewed by executive management ACRP The Monitor, Marcarelli, April 2007, p 83-84

  10. Best Practices in Medical Devices Trials For more information contact: Susan M. Rockwell, Manager, Clinical Trials and Clinical Development (508) 643-0434 x 113srockwell@mdci.com