The MHRA GCP Inspectorate Symposium was held recently in Leeds, UK. There was an extremely positive atmosphere and great opportunities to discuss with the inspectors during the day. The topics covered included quality systems and effective CAPA, computer system validation, handling of safety data and reference...

We are using eTMF (electronic Trial Master File) more and more in clinical trials, but the sponsor eTMFs are not always met the requirements by the inspectors, which resulted several recent inspection findings. Here are 7 recommendations for how to ensure inspection readiness of eTMF. Prior to...

Albert Einstein:
Success = Work + Play
Successful business = Knowledge + Quality
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