Molecular IP is now one paste away from leaving the company.
Tokto puts every prompt your scientists, clinical operations team, regulatory affairs group, and CRO partners run, every model output that touches a molecule, a patient, or a trial, under one auditable trail the FDA, the EMA, the IRB, and the GxP auditor can read.
An R&D scientist pastes a lead compound structure and unpublished trial results into a public LLM to draft a summary. The CISO finds out two days later from a vendor security advisory. The compound is now outside the company's control. The IND is six months out.
What you get with Tokto
- Every prompt and model output tied to a molecule, a trial, a site, an investigator, a patient identifier, and a model version.
- A 21 CFR Part 11-grade audit log that satisfies the FDA, the EMA, the IRB, OCR, and the GxP auditor on the same evidence.
- Policy applied at the prompt: PHI blocked, compound and trial codenames redacted, CRO partner boundaries enforced before tokens leave the company.
- On-prem and GCC-High deployment for PHI- and IP-sensitive workloads. Raw data never leaves the perimeter.
How it works
Tokto sits at the AI control plane of the company. Every research co-pilot, every clinical operations assistant, every regulatory drafting tool, every CRO-shared model becomes a record at the moment of output. The record carries the molecule, the trial, the site, the investigator, the patient identifier, the model version, and the policy in force.
When the FDA asks for the AI history behind a Part 11 record, when OCR opens a HIPAA inquiry after a vendor breach, when the IRB asks how patient data was governed in an AI-assisted protocol, the answer is one query against the system of record. The CISO no longer has to reconstruct it from email.
What goes wrong without it
- A scientist pastes molecular structure into a public LLM. The compound is now outside the company's control. Industry research shows 83% of pharma operates without basic AI controls.
- A vendor CRO co-pilot retains trial data past the contract. CamoLeak-class loss of unpublished trial results before anyone reads the log.
- An EMR-embedded AI tool ingests PHI without consent capture. Serviceaide-class breach of 400,000+ patient records.
- An ITAR-adjacent dual-use research query routes through a non-US model. Export control exposure on top of HIPAA.
On January 6, 2025, HHS OCR proposed the first major HIPAA Security Rule update in 20 years, removing the distinction between required and addressable safeguards and tightening risk management and resilience expectations. In May 2025 the Serviceaide breach exposed PHI for 483,126 Catholic Health patients through an unsecured database. Industry research finds 83% of pharma organizations operate without basic technical controls preventing molecular structures, trial data, and PHI from leaking into public AI tools.
See how Tokto makes enterprise AI visible, governed, and accountable for Security & Technology in Life Sciences.
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