Clinical study inspections – Optimized audit/FDA inspections results

At PMI, our experience with clinical study inspections by relevant regulatory authorities is systematically integrated into our audit procedures. To optimize audit results, we work closely with you to clearly establish audit objectives, gain a detailed understanding of the study protocol history, review observations made during ongoing study monitoring, and to understand previous issues identified by relevant regulatory authorities.

Within the context of the audit plan, our auditors work discreetly onsite to identify procedural deficiencies. When we review audit results with you, we generally include an assessment of the significance of deficiencies noted and a proposed plan for addressing them.

Our Audits/FDA Inspections services include:

• Good Clinical Practice (GCP) audits
• Good Laboratory Practice (GLP) audits
• Onsite assistance with FDA BIMO inspections