How Does AI Fit Into Your Clinical Oversight Model? Connecting at SCOPE
If you’re attending SCOPE Summit, this is a conversation worth having now, not later.
How does AI actually fit into your clinical oversight model?
That’s the question many trial sponsors are quietly asking right now, as AI moves from concept to day-to-day use, and assumptions give way to accountability. The shift is not about adopting technology for its own sake. It is about whether AI can strengthen sponsor oversight in ways that are credible, explainable, and inspection-ready.
Seeking Partners at SCOPE
Just in Time GCP is meeting with a small number of innovative trial sponsors who are ready to deploy AI that is already built, proven, and delivering inspection-ready value today.
This is not experimental technology.
Our AI is purpose-built to support sponsor oversight of clinical trial records and vendor deliverables. It can review thousands of eTMF records efficiently and effectively, surface meaningful quality signals, and focus attention where risk actually exists.
Built using inspection-informed logic and predefined patterns, grounded in more than 20 years of GCP experience supporting over 100 clinical inspections, the technology is designed to reduce manual oversight burden without replacing human judgement. The goal is oversight that improves quality, not busy work.
Built for Accountability — On Purpose
From the start, we made deliberate choices about how AI should be used in regulated clinical environments.
Our technology is supported by our AI Accountability Charter, which defines:
- Clear context of use tied directly to sponsor oversight responsibilities
- Explicit human ownership and decision-making
- Explainable, reviewable outputs that stand up to scrutiny
- Ongoing lifecycle oversight of the technology itself
These principles align with all ten of the themes reinforced in the recently released FDA–EMA AI guidance – expectations that many sponsors are already being asked to articulate clearly, particularly when demonstrating how they are keeping tabs on CROs and other trial partners.
Who We’re Looking to Partner With
We’re looking for a small group of trial sponsors who want to move from discussion to execution and who value practical, credible innovation.
This is for teams that want to:
- Apply AI in specific, purpose-driven ways
- Reduce operational burden without introducing new risk
- Strengthen sponsor oversight while staying inspection-ready
- Confidently demonstrate to regulators how oversight is performed across vendors and systems
Our ideal partners tend to be:
- Small and mid-size biotechs
- Sponsors motivated by ICH E6(R3) expectations
- Leaders who value substance over buzzwords
- Organizations that are done talking and ready to act
Let’s Talk at SCOPE
Our Head of Innovation, Aaron Grant, will be at SCOPE meeting with teams who want to stop talking about AI and actually start using it, responsibly and with accountability built in. If that sounds like you, connect with Aaron and stop by Booth #433.
Let’s shape the next era of clinical oversight and compliance together.
