1 / 10

Best Practices in Medical Device Clinical Trials

Best Practices in Medical Device Clinical Trials. May 18, 2007 Susan M. Rockwell, Manager, Clinical Trials and Clinical Development Medical Device Consultants, Inc. Today’s Topics. Clinical Trial Contracts Outsourcing to a CRO

corinthia-verga
Download Presentation

Best Practices in Medical Device Clinical Trials

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related