Health

Clinical Study and Ethics Agent

The ethics application waits for the sponsor contract. Not a single patient is enrolled in the meantime.

Guides you through contract clauses, the ethics pathway and research data up to study start.

Open agent
Public administration

Four processes that take up the most time today

Developed in Germany · Hosted in the EU

Developed in Germany · Hosted in the EU or on-premises

Delivered together with

STACKIT Sovereign hosting in Germany, single-tenant from the first user.
Rödl Legal, tax and compliance expertise for legally sound deployment.
4P Consulting Advisory and implementation for the public sector, starting with the AI readiness assessment.

Study start hinges on clauses that nobody in the hospital may sign alone.

The sponsor contract arrives as a draft, usually in English, with its own clauses on liability, publication and data use. The clinical trials office reviews the substance, the legal department the legal side, and the research data question is sent off separately on top of that. Meanwhile, the ethics application waits for the signed contract.

1draft contractThe sponsor submits its version, with its own clauses on liability and publication.
3reviewersThe clinical trials office, the legal department and data protection see the same text one after another.
2negotiation roundsEvery comment goes back to the sponsor and comes back changed.
1ethics applicationIt waits for the final contract and adds its own deadline to the lead time.

The 24-month publication period, rather than 12, is already flagged and on the table in the first round, and contract review runs 45% faster.

The 45% is this agent's headline figure. The three reviewers and two negotiation rounds reflect a typical path to study start; they are not measured values.

Three steps through the process.

The legal department negotiates and signs; the agent checks the contract clauses against the hospital's standard position and shows the approval pathway.

Check clauses against the standard position

The agent reads the sponsor contract and flags the clauses on liability, publication and data use. For each, it states where the hospital's standard position differs, with the reference.

Study ONK-2026-07, 4 clauses flagged, publication period 24 months instead of 12

Show the approval pathway to study start

The agent sets out the stages up to study start in order. For each stage, it names the document required there.

Pathway with 5 stages, 2 documents still outstanding

Submit the memo for signature

The agent summarises flagged clauses, data requirements and open stages in a memo. The legal department leads the negotiation.

vertragsvermerk_ONK-2026-07.docx, 4 clauses, 2 outstanding documents

What the agent does not do.

It does not negotiate the contract.

It flags the clauses and states the hospital's standard position on each. The legal department negotiates and signs.

It does not replace an ethics committee opinion.

It shows the pathway and the documents needed along it. The committee gives the opinion.

It does not release any research data.

It identifies the data requirements set out in the contract. The clinical trials office and the legal department settle the release.

Connected systems

  • Contract management
  • document management
  • study management

Operations

  • Deployment modelEU cloud, private cloud or on-premises
  • Data processingGDPR-compliant, no model training on your data
  • Responsible teamsClinical trials office, legal department, research

The questions that come up before the first meeting.

How quickly is the Clinical Study and Ethics Agent ready to use?

A pilot typically runs on your own data within 4 to 6 weeks. The agent connects to your existing systems rather than running as a separate, parallel environment.

Where is the data processed?

EU cloud, private cloud or on-premises. Processing is GDPR-compliant and models are never trained on your data. Details in the Trust Center.

Where does the figure “45% faster contract review” come from?

It is based on experience from comparable projects and process benchmarks, not a commitment. We work out the realistic effect for your organisation during the assessment before the pilot.

Related agents.

Intake review, case 2026/04711

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