In recent years, more and more companies have requested compliance assessments and validation of computerized systems used in clinical trials.
Requests have increased especially following the "Notice to sponsors on validation and qualification of computerized systems used in clinical trial" issued by the EMA on 7 April 2020.
Since 2008 we have been providing IT compliance support to clinical departments of pharmaceutical companies and directly to CROs. Here you can find the projects we have successfully conducted in the GCP field, as well as the regulatory references and guidelines on which we rely to set up the activities.
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