To facilitate virtual TMF inspections and improve efficiency, the 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.
Although sponsors agree that a sponsor-owned eTMF provides more control, they ask how to implement this strategy successfully.
In this webinar, Pinar Benet, senior director of Vault Clinical Operations at Veeva Systems, spoke with Pawel Rucki, senior manager of TMF operations at GW Pharmaceuticals, about GW Pharma’s transition to an in-house TMF model, the benefits of sponsor TMF management, and best practices for making the switch.
Originally held on 26 January 2021