In clinical research, speed and quality are often at odds, especially when validating study-specific software. Timelines are tight, complexity is high, and everything hinges on getting to First Patient In (FPI) without compromising compliance.
We see significant opportunities for AI to accelerate validation by drafting test scripts from a human-authored test plan. It’s not about replacing humans. It’s about reducing cycle time and freeing experts to focus on strategic oversight and final QA.
With the FDA now accepting generative AI-assisted protocol drafting, a precedent has been set: if it works for science, it can work for software. The question is no longer if we should apply AI to software validation, but how to do it safely and effectively.
The Precedent: Generative AI in Protocol Development
A recent study sponsored by the Boston Consulting Group (BCG), From RAGs to riches: Utilizing large language models to write documents for clinical trials, confirmed that generative AI can reduce protocol development timelines by 25–50%, provided there’s human review. This proves that AI-generated outputs are acceptable in highly regulated domains, so long as qualified experts verify the inputs and outputs. This same principle applies to eClinical software validation.
Where AI Belongs: Test Script Drafting from Human Plans
Study-specific software must be validated before First Patient In (FPI). Today, that means fully manual testing: writing the plan, authoring test scripts, executing test cases, managing defects. Teams spend hours authoring test scripts line by line. It’s slow, and a poor use of expert resources. All of this time-consuming manual work is often a bottleneck for go-live.
Our recommendation: use AI to generate test scripts from a structured, human-authored test plan. This approach preserves rigor and traceability while dramatically reducing time-to-execution.
It’s fully possible to integrate generative AI into validation as long as you maintain a human-in-the-loop:
- Validation experts write the plan (the input)
- Generative AI drafts the scripts
- Testing is completed per the existing test strategy (manual, automated, hybrid)
- Experts review, refine, and sign off (the output)
Remove the Bottleneck, Keep the Human
At Studion, we’ve executed thousands of hours of manual validation. We understand the regulatory context and what makes software patient-ready. That’s why we know how, and where, to safely introduce AI.
Generative AI isn’t replacing humans in eClinical validation. It’s amplifying their impact. By applying AI to the most time-consuming steps (like test script drafting) and keeping experts in control of strategy and QA, we make it possible to deliver validated, study-specific software faster than ever. It’s not a compromise. It’s a smarter process.
