How to Improve CRO Oversight by Bringing Your TMF In-House

By Veeva Systems

To facilitate virtual TMF inspections and improve efficiency, the European Medicines Agency (EMA) encourages sponsors to provide inspectors direct system access to the eTMF on an ongoing basis.

In response, sponsors have increased their willingness to bring the eTMF in-house and have CROs work directly within the sponsor eTMF.

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