Life Sciences leaders are asked to move faster on AI and to prove control to boards, inspectors, partners and insurers, while R&D data, clinical data and validated systems raise the stakes. The ANG AI Trust Compass is a fixed-scope advisory engagement that answers the question each of you owns. ANG Associates comes from Life Sciences and IT delivery, so R&D, Quality, IT and the board can work with us in one conversation. Scope and fees are set in a scoping call.
CEO and executive team
Are we moving fast enough on AI, and can we show our board and partners that we are in control?
What you receive
- Risk tiers and approval routes, so low-risk AI use cases move now and GxP-critical ones are validated first.
- A short list of use cases for concentrated investment, with baselines and success measures.
- A one-page board view of what is live, what it costs and which risks were accepted.
Suggested start: Safe Fast-Track, plus AI Audit Readiness when a board, inspector or partner is already asking.
CIO and IT leadership
Which AI use cases can go into validated, regulated environments, on which platforms, and with what evidence?
What you receive
- An AI inventory with owners and risk classification.
- A gap assessment against ISO/IEC 42001, the NIST AI RMF and, where relevant, the EU AI Act, read against the direction of the EMA and FDA principles and draft Annex 22.
- An independent comparison of deployment options for your most sensitive workloads, with hosting and jurisdiction mapped.
- An evidence pack and rehearsal questions for auditors and inspectors.
Suggested start: AI Audit Readiness, then Sovereign Path for the most sensitive workloads.
CISO and security leadership
Where is AI really used, what can our agents reach, and which confidential information is exposed?
What you receive
- A map of actual AI usage across teams and tools, with crown-jewel information such as R&D, clinical and process know-how named and ranked.
- An agent inventory with identity, permissions and data reach, and a least-privilege remediation plan.
- Design for approvals, logging and shut-off, plus an incident tabletop.
Suggested start: AI Exposure Check, then Agent Access Review.
Also for General Counsel, Quality, Regulatory Affairs and Finance: AI Audit Readiness, Sovereign Path and the AI Coverage Gap Review are built for your questions, and we work with your counsel and broker rather than replace them.
AI Exposure Check
Where do R&D, clinical and process data meet AI tools?
Discovery data, trial data, formulations and process know-how are the assets. We map where they reach public or unapproved AI tools, and which vendor terms and retention settings apply to them.
AI Audit Readiness
Can we show auditors and inspectors how our AI is controlled?
We prepare the evidence pack: AI inventory, intended use, risk classification, validation and change control records, monitoring and human oversight. This follows the direction of the EMA and FDA principles and draft Annex 22. We prepare you; we do not certify.
Agent Access Review
What can AI agents reach inside validated and regulated systems?
We review agent identities, permissions and logging around systems such as document management, quality, laboratory and ERP platforms, and how agent actions fit your data integrity and change control expectations.
Safe Fast-Track
Which AI use cases can go live now, and which need more control?
We sort your portfolio of use cases by risk, for example literature review, drafting support, deviation triage or commercial content. Low-risk cases move with guardrails; GxP-critical ones get the validation they need before they go live.
AI Coverage Gap Review
Do our policies respond when AI touches quality or safety decisions?
We prepare the questions and the AI use picture that your broker needs to review product liability, cyber and professional liability cover. We are not a broker and give no coverage opinions.
Sovereign Path
Where may our data and models live, and who can access them?
For clinical and patient-related data and cross-border transfers, we compare hosting and model options in Switzerland and the EU, and prepare the questions for your legal counsel and data protection officer.
Jan 2026
EMA and FDA published ten guiding principles of good AI practice in drug development, covering the medicine lifecycle from early research and clinical trials to manufacturing and safety monitoring. They are broad guidance, not binding law.
EMA news release, 14 January 2026
The Kiteworks figure is cross-industry, vendor-run and from 2025, so we read it as a signal. Regulatory status changes; please verify against the EMA and your own regulatory team before relying on any of it.