Beware & Be Prepared for FDA Clinical Trial BIMO Inspections

During 2007, CDRH’s Bioresearch Monitoring Division identified significant regulatory violations in 1/3 of its 40 trial sponsor inspections and issued 8 warning letters. Serious violations included insufficient monitoring and use of unqualified monitors by the sponsor, failing to submit progress reports, and failure to obtain IRB approval. These sponsor violations, which represent a significant increase from 2006, resulted largely from “For Cause” inspections arising from complaints received from trial subjects, investigators, whistle blower employees, FDA reviewers and competition. Because such complaints have been on the increase for several years, FDA created a special investigations branch to respond to them.

Anson Group advises clients to consider mock BIMO inspections as means of protecting the integrity of clinical trials. Data audits, and remediation projects, as well as mock BIMO inspections are among the clinical research services Anson offers.