Rochelle L. Goodson:
An independent consultant and the President of R. L. Goodson Consulting, Inc., a firm specializing in GCP compliance auditing and consulting since 1995. Ms. Goodson’s collective experience in the clinical research industry has spanned almost 30 years and includes the monitoring and auditing of all phases of clinical research and regulatory due diligence compliance. She established a Clinical Quality Assurance Department at Sanofi-Synthelabo, Inc. and had responsibility for the development and implementation of all the functional and auditing activities of the department. Previously, she participated in projects resulting in INDs, ANDAs and NDAs at both Sanofi-Synthelabo, Inc. and Wyeth Laboratories, Inc. Ms. Goodson has presented on Quality Assurance, Good Clinical Practices, and FDA Oversight of Clinical Research topics at various industry-related professional meetings, courses, and seminars. She has conducted numerous training courses and field training exercises for clinical monitors and auditors. At present, Ms. Goodson is a member of ACRP, RAPS, DIA and SQA. She chaired the SQA GCP Planning Committee for several years and currently serves as Co-chair of the SQA Clinical Specialty Sub-committee and is a founding member of the Leadership Committee. Ms. Goodson has also chaired the Annual Meeting Program Planning Committee, Clinical Program Planning Committee, and the Liaison Committee of SQA.