This past week FDA completed a detailed pre-approval audit of a regulatory submission. The audit included a detailed evaluation of Good Clinical Practices as well as a detailed look at Target e*CRF®. There were no unexpected findings and there were NO findings related to Target e*CRF®. In fact, the FDA auditor was quite interested in Target e*CRF® and spent quite a bit of time discussing 21 CFR Part 11 issues.

For more information, please contact Dr. Jules T. Mitchel or Joyce Hays. For new business opportunities, contact Adrian Pencak, Vice President, Business Development).