Good Clinical Practice for Sponsors of Clinical Trials
Presented by Mary Bernadette Ott
Recorded On: Tuesday, October 09, 2012
Implementing Good Clinical Practice regulations is imperative for successful clinical trials.
Mary Bernadette Ott
Mary Bernadette Ott is a GCP compliance consultant, conducting sponsor/monitor audits and clinical investigator site audits for numerous pharmaceutical, biotechnology and medical device companies. She has audited IRBs, central laboratories, central reading facilities, CROs, and Phase I clinical units. She frequently conducts GCP classes for individual companies, as well as for DIA, ACRP, and other trade groups.
Previously, Bernadette served with the FDA as a field investigator in the Philadelphia District Office, and as a supervisor in the Boston District Office. There she was responsible for evaluating food, drug and device companies in the areas of GMP, GCP and GLP compliance.
Bernadette is co-author of Guide to Good Clinical Practice, published by Thompson.