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

2. © Medical Device Consultants, Inc. 2007 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. © 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

4. © Medical Device Consultants, Inc. 2007 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. © Medical Device Consultants, Inc. 2007 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. © Medical Device Consultants, Inc. 2007 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. © Medical Device Consultants, Inc. 2007 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. © Medical Device Consultants, Inc. 2007 Five Habits of Highly Effective Sponsors 5. Clinical study progress reviewed by executive management ACRP The Monitor, Marcarelli, April 2007, p 83-84

9. © Medical Device Consultants, Inc. 2007 Five Habits of Highly Effective Sponsors 1.Establish SOPs for clinical study functions 2.Hire employees with experience in conducting clinical studies 3.Utilize consultants/CRO 4.Conduct audits of clinical processes and procedures 5.Clinical study progress reviewed by executive management ACRP The Monitor, Marcarelli, April 2007, p 83-84

10. © Medical Device Consultants, Inc. 2007 Best Practices in Medical Devices Trials For more information contact: Susan M. Rockwell, Manager, Clinical Trials and Clinical Development (508) 643-0434 x 113 srockwell@mdci.com srockwell@mdci.com