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Risk-Based Source Data Verification Adoption Rises to 96% in Clinical Trials
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Fusion42 · 22 September 2026 · Fusion42 review
Risk-based monitoring with configurable source data verification (SDV) is now used in 96% of clinical trials, improving efficiency by focusing oversight on higher-risk data and allowing remote SDV. AI aids SDV by highlighting discrepancies for human review but does not replace monitor judgment, addressing regulatory scrutiny on documentation accuracy.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Regulatory demands now tie SDV accuracy to trial success and cost efficiency, so you must refine your monitoring plans and integrate AI to reduce errors without losing human oversight. Focus investment on configurable verification and AI tools that flag, not replace, human checks to stay ahead of FDA compliance risk.
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1 source · 22 Sep 2026
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