Quality Assurance

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As you would expect from a CRO involved in clinical trials, we place a very high emphasis on our internal Quality Assurance.

PSR has been audited 30 times since 2002 (including our own scheduled internal audits).  Audits from clients have included Systems Audits, GCP study audits and database and IT systems audits.  No critical findings were found and in all cases the clients were satisfied with the outcome of the audit.

Our internal Quality System includes:

• A comprehensive Quality Manual
• A recently revised set of SOPs, covering the following areas:            
               - QA
               - Clinical Operations
               - CPU
               - Data Management & Biometrics
• An annual audit plan for internal audits of all our offices

We also place considerable importance on the training of our employees. Our Training System includes:

• A comprehensive in-house training program, with several facets: 
               - An introduction program for new employees
               - In-class training modules 
               - SOP-quizzes
• ACRP-certification for CRAs
• Up-to-date personal training files
• Regular in-house Q&A sessions 
• External training courses for CRA-starters