Hybrid AI for CROs and CDMOs
AI Your Sponsors Can Audit. Data They Can Trust You With.
You hold many sponsors’ confidential data at once. Axenivo keeps each sponsor’s trial, batch and safety data in its own private space in your cloud, uses managed models only for public work, and gives every sponsor an audit trail they can inspect.
The Same Five Problems, With a Twist
Shadow AI, stalled pilots, generic output, runaway cost and inspection scrutiny all apply. For service providers, each one also becomes a sponsor-relationship risk.
Sponsor Data Mixing
A general assistant has no idea which sponsor a document belongs to. One wrong paste can breach a confidentiality agreement.
Sponsor Audits
Sponsors now ask how you use AI on their studies and batches, which data it saw and who approved the output.
Margin Pressure
Work is priced per study or per batch. Per-token AI fees that grow with document volume eat directly into margin.
Different Rules per Sponsor
One sponsor allows managed AI for literature, another forbids all external AI. Your tooling has to follow both.
What Goes Where for a Service Provider
The policy check knows which sponsor each request belongs to. Sponsor data always stays private; public-only work can use managed models where that sponsor allows it.
| Task | Route | What the model sees |
|---|---|---|
| Monitoring visit reports | Private AI | Site data, deviations and CRA notes for one sponsor’s study |
| eTMF quality checks | Private AI | Trial master file documents and your filing index |
| Medical writing for sponsors | Private AI | Source tables and the sponsor’s own templates |
| Pharmacovigilance services | Private AI | Adverse event reports for the sponsor’s products |
| Batch record review (CDMO) | Private AI | Executed batch records and the product’s master batch record |
| Deviation and CAPA drafting (CDMO) | Private AI | Deviation reports, investigation notes and your quality SOPs |
| Technology transfer packages (CDMO) | Private AI | Process descriptions, specifications and development reports |
| Public guidance and literature | Managed AI | Public texts only, when the sponsor allows managed AI |
Built for Many Sponsors at Once
- Sponsor-Scoped KnowledgeEach sponsor’s SOPs, templates and study documents sit in their own indexed space.
- Per-Sponsor AI PolicyManaged AI on or off per sponsor, per study or per task type.
- Per-Sponsor Audit TrailRequests, sources, routes and approvals logged and exportable for each sponsor.
- Role-Based AccessStaff see only the sponsors and studies they are assigned to.
- Qualification EvidenceDocumentation to support sponsor audits, supplier qualification and computerised system validation.
- Predictable MarginsNo per-token fees on confidential work, so cost does not grow with every document.
Questions from CROs and CDMOs
Can one sponsor’s data ever appear in an answer for another sponsor?
No. Each sponsor gets its own knowledge base, access roles and audit trail inside your cloud account, and retrieval is scoped to the sponsor a user is working for. Cross-sponsor access has to be granted explicitly.
Can we show a sponsor how AI was used on their study?
Yes. Every request, source, route and approval is logged per sponsor, so you can export the evidence a sponsor audit or qualification questionnaire asks for.
Can a sponsor forbid managed AI on their work?
Yes. Managed AI can be switched off per sponsor, per study or per task type. When it is off, everything runs on private models in your cloud.
Does Axenivo replace our CTMS, eTMF, safety database or MES?
No. Those stay your systems of record. Axenivo reads from and drafts for them, grounded in your SOPs and each sponsor’s requirements.
Discuss a CRO or CDMO Pilot
Start with one team and one sponsor. Your QA and IT teams review in parallel, with documentation we supply.