Case Studies on Scientific Support

This Pharmaceutical Manufacturer is contracting most of the nonclinical bioanalytical phase of GLP studies at Contract Research Organizations (CRO).  Because of the number of studies involved, its study monitors, were not able to provide the attention required to the bioanalytical data and reports.  QAI was hired to provide this service.  One employee performed a scientific review of the bioanalytical data of several studies at each CRO.  The data of each batch was examined in the native software (generally Analyst), with particular attention to integration parameters, process used for reintegrations, and batch acceptance based on calibrators, Quality Control and blank responses.  The chromatograms were examined for possible interferences, or for improper integration.  Up to three QAI employees reviewed all bioanalytical reports submitted by these laboratories, in particular to verify adherence to the sponsor template, to FDA guidance, and to the consistency of the text and tables.  The comments were sent to one employee at the Pharmaceutical Manufacturer, who coordinated the responses.  In most cases, QAI made requests for revisions to the reports before they were finalized, and verified the changes before the reports were signed.  All exchanges of documents were handled through the respective portals of the Pharmaceutical Manufacturer or the CRO.

This small company is in the process of developing a new sterilization process, both with a product that has never been approved for this use, and with sterilizers designed by the company for this specific use.  Several studies were required to be performed for submission to EPA and FDA.  The company decided to perform the antimicrobial efficacy and some operator exposure studies in-house.  In addition to helping this company set up a GLP program for these studies, one QAI employee was designated to provide regulatory and technical review assistance in the development of the protocols, writing SOPs, and drafting the study reports.  This effort was provided for the better part of a year, generally three days per week.