FDA Warning Letter

Issue:

A major contract research organization (CRO) received an FDA warning letter requiring them to either reassay all samples or re-run the clinical and bioanalytical portions of all bioequivalence studies for the past 5 years for due to misconduct and poor scientific practices.

Stubbs & Hensel Intervention:

• Research: S & H met with key management and scientific staff at the CRO to determine the extent of the issues.  This then lead to meetings with FDA and legal counsel
• Scientific Strategic Planning: S & H worked jointly with the CEO, VPs of Bioanalysis and Quality, legal services and the FDA to agree on a scientifically based audit protocol which, when followed, would allow for the mitigation of regulatory risk for studies conducted from 2008 through 2010.

Results

• S & H created a proprietary Electronic Data Audit Protocol which was approved by the FDA to be used by any third party auditor for the auditing of all bioequivalence studies conducted in the time interval specified above. 
• Stubbs & Hensel completed approximately 68 client audits over the past 14 months; 49 of which were identified as having Low Regulatory Risk with the potential of saving the client pharmaceutical companies the cost and time to repeat additional bioequivalence clinical studies and subsequent bioanalysis.