AI in pharma is now regulated like a clinical instrument.
Tokto records every prompt your team runs across research, clinical, regulatory, and commercial, ready for the program lead, the GxP auditor, the IRB, and the FDA.
Your team has been using a new co-pilot for two months. The program lead asks who validated it, the GxP auditor asks for a record, the IRB asks about patient data. No one has a single answer that matches.
What you get with Tokto
- Every AI interaction tied to a program, a trial, a function, and a model version.
- A single record that the program lead, the GxP auditor, and the IRB can read against the same evidence.
- Policy at the prompt: PHI blocked, compound IP redacted, CRO boundary enforced before content reaches the model.
- AI used at the speed of the science with the record the company needs.
How it works
Tokto sits inside every AI conversation in the company. The research co-pilot, the regulatory drafting tool, the CRO-shared model — all become records at the moment of use. The record carries the program, the trial, the function, the model, and the policy that applied. Practitioners get the speed; the company gets the trail.
When the program lead asks who used what, when the GxP auditor asks for the trail, when the IRB asks about patient data, the answer is one query. The team uses AI; the company stays inside Part 11.
What goes wrong without it
- A vendor tool gets used across three functions before anyone notices. The GxP auditor finds out at audit.
- A scientist pastes compound IP into a public model. It is now outside the company's control.
- A clinical assistant retains PHI past the trial. The company cannot produce a deletion record.
- A function's AI cost runs over by 10x in a quarter. Nobody can say where it went.
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 Teams in Life Sciences.
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