Independent consultant for Clinical Quality Assurance Service and GCP Training (e.g., for FORUM Institute). Former senior director quality assurance in a Contract Research Organization.
Fifteen years of clinical trials experience in the pharmaceutical industry including staff management.
Twenty years of clinical research experience in a Contract Research Organization, mainly in Global Clinical Quality Assurance, e.g., audits of clinical investigator sites, vendors (organizations, labs, drug depots etc), including staff management and GCP training.
International coverage of auditing activities:
Ph.D. in Chemistry and Pharmacology (Dr. rer. nat.)
Max-Planck-Institute for Medical Research, Heidelberg, Germany
M.Sc. Chemistry (Dipl.-Chem.)
Ruperto-Carola-University, Heidelberg, Germany
Example for Clinical Investigator Site Audits
If not directed or for cause, investigator site audits are used to identify important protocol and GCP non-compliance, and they may include an assessment of CRA monitoring performance. As an example, depending on the scope of an investigator site audit typically includes time for preparation, Trial Master File in-house review and time for audit activities at the clinical investigator site such as, for example: