Case Study: Automating Site Personnel Oversight — AI with Purpose, Not Hype
Managing site personnel documentation is one of the most time-consuming and error-prone tasks in TMF oversight. For large studies, confirming qualifications, licenses, CVs, and delegation logs can take 2.5–4 hours per site. For a 200-site study, that’s nearly 80 hours of manual review — and even then, errors often remain, creating inspection risk.
Traditional tools don’t close these gaps, forcing teams to manually navigate the TMF, cross-check DOAs, 1572s, CVs, and licenses, and confirm expirations or role changes. The result is a process that is both tedious and inspection-sensitive.
The Challenge
Manual reviews often uncover:
- Investigators missing from DOA or 1572 logs
- CVs or financial disclosures not on file
- Licenses missing, expired, or issued for the wrong state
- Investigators with undefined or conflicting roles
- Metadata mismatches across documents
- Duplicate or unsigned files
Each of these gaps adds inspection risk. Weak site personnel records often signal broader compliance issues that jeopardize trial integrity.
The Solution: AI with Purpose
Just in Time GCP applied AI trained on two decades of TMF expertise to automate site personnel oversight. Unlike generic AI pilots that fail to scale, this solution is embedded in proven compliance workflows and aligned with inspection readiness standards.
Click here to read about Just in Time GCP’s expanding Innovation Team.
The AI reads every document, flags missing or inconsistent records, and produces structured reports that highlight site- and study-level risks. This allows sponsors to:
- Cut review times from hours to minutes
- Review all sites, not just samples
- Detect broader compliance issues early
- Free study teams to focus on trial execution and solving more systemic issues
As the MIT State of AI in Business 2025 report noted:
“Large language models seem simple — you can give them instructions in plain language, after all. But it takes expertise and experimentation to embed them in business workflows.”
This is where most AI fails — but also where Just in Time GCP succeeds.
The Results
- Efficiency: Review time reduced from 2.5–4 hours per site to minutes
- Coverage: Comprehensive oversight across 200+ sites
- Risk intelligence: Personnel documentation gaps identified as early signals of broader site risk
- Inspection readiness: More complete documentation, fewer findings, greater confidence
The MIT report also found that purchasing AI solutions succeeded 67% of the time, while internal builds succeeded only one-third as often. Our solution proves why: AI built on compliance expertise works, where generic pilots fail.
Why It Matters
AI pilots fail 95% of the time because they lack focus, workflows, and expertise. By targeting site personnel oversight — a critical but resource-heavy process — Just in Time GCP demonstrates that AI with purpose, not hype, delivers measurable value.
Sponsors gain what regulators demand: completeness, quality, and timeliness in their TMF, with risk-proportionate oversight and inspection-ready confidence.
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