Pharma & life sciences
Faster development with AI. Trial data never ends up in the wrong hands.
Pharma and life sciences process clinical trial data, patient information and proprietary research results. GxP rules, FDA 21 CFR Part 11 and the EU Clinical Trials Regulation set the highest requirements for data integrity and confidentiality. AI accelerates drug development, but trial data must not end up in the wrong hands.
The challenge
Why AI has hardly been permitted here so far.
Relevant regulations
- GxP
- FDA 21 CFR Part 11
- EU Clinical Trials Regulation
- 01Clinical trial data contains patient names, diagnoses and treatment histories.
- 02Proprietary compound data and research results are trade secrets.
- 03GxP compliance requires full traceability of every data processing step.
- 04Adverse event reports contain personal information.
Anonix in practice
What the AI provider actually sees.
The example uses fictitious demonstration data. The placeholders show which information Anonix detects and replaces.
Instruction to the AICreate a structured adverse event report in CIOMS format from this data.
4personal data items replaced
01 · Your original
Participant ID-4821, investigator: Dr. Maria Engel. Adverse event: nausea grade 2 after Compound XR-7.
02 · Sent to the AI
Participant [ID_1], investigator: [PERSON_1]. Adverse event: [SYMPTOM_1] after [COMPOUND_1].
03 · Your result
CIOMS adverse event report
Participant: ID-4821 · Investigator: Dr. Maria Engel
Event: nausea grade 2 · Suspected substance: Compound XR-7 · Causality: possible · SAE: no
Action: symptomatic treatment, continued observation.
Data types detected in this example
- ID
- PERSON
- SYMPTOM
- COMPOUND
Nothing changes for your staff.
Your software calls the AI as usual. Anonix sits in between, replaces the personal data and puts it back into the response. Integration consists of two changed lines: API address and API key. This works with OpenAI®, Claude® and Gemini® as well as with self-hosted models.
Let’s talk abouthow you useAI.
In a short conversation we show you how Anonix fits your organisation: which providers, which data, which rules. No obligation.