Developing an efficient TMF management process with a lean clinical team

How can smaller companies efficiently execute an audit-ready eTMF with a small yet nimble “Lean” team? This presentation examines how Scimega Research, a niche Canadian oncology CRO, deployed Connect eTMF from set-up, to document upload, to QC, to audit preparedness with accuracy and speed.

Learning objectives:

1. Understand the steps a smaller organization can implement to maximize the utility of an eTMF
2. Identify background processes needed to stand-up eTMFs and train users
3. Appreciate how to maintain the eTMF audit-ready through intelligent use of available QC processes

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