Just in Time GCP – AI Accountability Charter
Innovation with purpose. Compliance with confidence.
When it comes to AI, not all solutions are created equal. That’s why our approach is grounded in over 20 years of clinical compliance expertise and aligned with ICH E6(R3), the EU AI Act, and FDA expectations for trustworthy, transparent AI.
Together, these principles form our AI Accountability Charter — five principles that guide every solution we deliver.
1. Transparency
Transparency means clarity at every step—from how data is used to how decisions are supported. In practice, this means our AI produces results that are explainable, reviewable, and always tied to clear business rules as well as regulatory expectations.
2. Data Ownership & Protection
Your data is yours — and stays that way. We use it only to deliver results, and never to train models. Moreover, our contracts and SOPs make this protection explicit, ensuring confidence and control at every stage.
3. Human Oversight
Every AI capability operates within a structured oversight process that ensures quality, accountability, and compliance. Through this framework, built-in controls and defined review points keep automation aligned with GCP expectations—so technology supports, not replaces, sound judgment.
4. Risk-Proportionate Oversight
AI should help you focus on what matters most. Accordingly, we align AI outputs to critical-to-quality factors and TMF risk signals — completeness, quality, and timeliness — thereby enabling trial-wide and record-level QC through continuous monitoring.
5. Regulatory Alignment
Innovation is only meaningful when it meets regulatory expectations. For that reason, our solutions are built on ICH E6(R3) principles, designed in line with the EU AI Act, and consistent with FDA and EMA guidance on trustworthy AI and ALCOA+ data integrity.
Our Commitment
When we say AI, we mean responsible, ethical, and inspection-ready AI — applied where it solves real sponsor problems, not where it adds noise.
(This charter is a living commitment, updated as regulatory guidance evolves. Updated 10/26/25)
