Case Study: Small Bio-Pharmaceutical Company achieves successful Mock FDA inspection and improved regulatory compliance with Advarra process assessments

Process Assessments Lead to a Successful Mock FDA Inspection

Bio-Pharmaceutical Company was conducting multiple large U.S. clinical study programs to support its first New Drug Application and needed assurance that study conduct, regulatory compliance, and process efficiency were adequate while resources were stretched. Advarra Consulting was engaged to assess critical clinical, safety, and biometrics processes and to support readiness activities.

Advarra performed synchronized process assessments across Clinical Operations, Clinical Trial Management, Quality Management, Pharmacovigilance/Drug Safety, and Biometrics, implemented recommendations, conducted a successful Mock FDA Inspection, and supported CTMS implementation (functional specifications, vendor selection, and project management). As a result, Advarra helped the company revise and create SOPs, close gaps from the assessments, implement an interactive training system, and materially improve compliance and operational efficiency ahead of the NDA filing.