BSI’s solution offers a very user-friendly interface that prioritizes an intuitive experience, thereby fostering seamless collaboration among study team members.
Seamlessly integrating with the BSI CTMS system ensuring data consistency across your entire clinical trial ecosystem.
Discover BSI eTMF in just 2 pages.
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Yes, eTMF is already a fully integrated module in BSI CTMS. All the trial related documents are accessible from the same user interface as CTMS.
Documents generated in the CTMS, e.g. monitoring visit reports, meeting minutes etc are automatically filed in the eTMF.
Yes, BSI eTMF contains workflows for review and approval of documents. Documents can be signed electronically, which is 21 CFR Part 11 compliant.
It is possible to either download the entire eTMF or only selected documents. Additionally, the audit trail can be included as part of the download.
Yes, auditors/inspectors can be given remote access to all the data including eTMF of a specific trial.
