20 December 2025
AI in eTMF
As clinical trials grow more complex and global, eTMF systems must evolve. The next frontier for eTMF is AI-driven transformation
Future eTMF platforms will embed AI that continuously monitors documentation quality and flags potential regulatory risks before audits.
Rather than static templates, AI can suggest workflow optimizations based on historical document patterns and trial behavior — improving completeness and timeliness.
Advanced AI can predict what documents will be needed next or which documents are likely missing — helping trial teams plan proactively.
AI will make eTMF part of a connected clinical ecosystem, where data flows effortlessly between eTMF, CTMS, EDC, and other trial systems.
The future eTMF won't just store documents — it will think about them. With AI at the core, it will proactively ensure quality, drive compliance, and simplify clinical trial documentation for global teams.
