Does the firm act for the sponsor or for the site?

Either, on a per-engagement basis. The firm reviews and negotiates clinical trial agreements from the sponsor side or the site side: for cantonal and university hospitals running investigator-initiated trials, for CROs contracting in the DACH region, and for Swiss biotech sponsors of EU or UK trials. A single engagement acts for one party only; the firm does not act for both sides of the same CTA.

Which law governs a clinical trial conducted in Switzerland?

Human research in Switzerland is governed by the HFG and its implementing ordinances, including the KlinV (Verordnung über klinische Versuche in der Humanforschung) for clinical trials. A trial generally requires authorisation by the competent cantonal ethics committee (Art. 45 HFG), and, where a therapeutic product is involved, additional authorisation by Swissmedic under the therapeutic-products regime. Authorised trials must be entered in a public register (Art. 56 HFG). A trial run in both Switzerland and the EU is subject in parallel to the EU Clinical Trials Regulation (Regulation (EU) 536/2014); the firm aligns the CTA to whichever framework or frameworks govern.

Who bears liability and insurance for trial subjects?

Under the HFG, the person who initiates a research project involving people is liable for damage suffered by participants in connection with the project (Art. 19 HFG), and that liability must be adequately secured by insurance or in another form (Art. 20 HFG). A clinical trial agreement allocates these duties between sponsor and site: who procures and maintains trial-subject insurance, who indemnifies whom, and how product-liability and protocol-deviation risk are apportioned. Mispositioned indemnities are among the most common defects the firm corrects.

What does a master CTA template deliver?

A master clinical trial agreement template is a pre-negotiated, reusable contract base that fixes the recurring positions (indemnity and insurance, intellectual-property ownership and licensing of trial results, publication rights and embargo periods, data protection under the DSG and the GDPR, budget and payment mechanics, and termination) so that each new trial requires only site-specific or protocol-specific changes rather than a full renegotiation. It shortens contracting cycles and keeps a sponsor's or site's positions consistent across a portfolio of trials.

Service

Clinical trial contracting.

A clinical trial agreement (CTA) sets the legal terms between a trial sponsor and a participating site. The firm reviews and negotiates CTAs for either side, handles regulatory queries under the HFG and the EU Clinical Trials Regulation, and builds reusable master CTA templates, on a volume-based framework retainer with a fixed fee per agreement.

Set up a trial framework

Who this is for

Cantonal and university hospitals running investigator-initiated trials.
Mid-size contract research organisations (CROs) contracting across the DACH region.
Swiss biotech sponsors of clinical trials run in the EU or the UK.

What's included

CTA review and negotiation: review and negotiation of the clinical trial agreement from the sponsor side or the site side, covering indemnity, insurance, intellectual property, publication rights, data protection and payment terms.
Liability and insurance allocation: apportionment of the sponsor's statutory liability for trial-subject harm (Art. 19 HFG) and the requirement to secure that liability by insurance or another adequate form (Art. 20 HFG) between the contracting parties.
Regulatory contracting queries: advice on how the authorisation regime (Art. 45 HFG) and the public-registration duty for authorised trials (Art. 56 HFG) bear on the CTA, and on the parallel requirements of the EU Clinical Trials Regulation (Regulation (EU) 536/2014) for cross-border trials.
Master CTA template development: a pre-negotiated, reusable template that fixes recurring positions so each new trial needs only protocol- or site-specific changes; specific KlinV and EU Clinical Trials Regulation provisions are confirmed at engagement.
Data-protection terms: the trial-data clauses under the DSG and, for EU-facing trials, the GDPR, including controller / processor roles and cross-border transfer of trial data.
Framework retainer: a volume-based retainer for sites and sponsors running multiple trials, with a fixed fee per individual CTA.

How it works

Scoping. The firm confirms which side it acts for, the trial's jurisdictions, and whether the work is a single CTA, a portfolio, or a master template.
Review. The firm marks up the agreement against the client's position and the governing framework: the HFG and KlinV in Switzerland, the EU Clinical Trials Regulation for EU trials.
Negotiation. The firm negotiates the contested terms (indemnity, insurance, IP, publication and budget) with the counterparty.
Template build. Where a master template is in scope, the firm distils the agreed positions into a reusable base for future trials.
Ongoing support. The firm handles successive CTAs against the framework on the retainer, at a fixed fee per agreement.

Indicative pricing

Framework subscription + per-CTA fixed fee

from CHF 6,000 / month

Per CTA CHF 3,500 to 7,500 for a full negotiation; CHF 2,500 to 3,000 on a master-CTA template.

Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.

Frequently asked questions

Does the firm act for the sponsor or for the site?: Either, on a per-engagement basis. The firm reviews and negotiates clinical trial agreements from the sponsor side or the site side: for cantonal and university hospitals running investigator-initiated trials, for CROs contracting in the DACH region, and for Swiss biotech sponsors of EU or UK trials. A single engagement acts for one party only; the firm does not act for both sides of the same CTA.
Which law governs a clinical trial conducted in Switzerland?: Human research in Switzerland is governed by the HFG and its implementing ordinances, including the KlinV (Verordnung über klinische Versuche in der Humanforschung) for clinical trials. A trial generally requires authorisation by the competent cantonal ethics committee (Art. 45 HFG), and, where a therapeutic product is involved, additional authorisation by Swissmedic under the therapeutic-products regime. Authorised trials must be entered in a public register (Art. 56 HFG). A trial run in both Switzerland and the EU is subject in parallel to the EU Clinical Trials Regulation (Regulation (EU) 536/2014); the firm aligns the CTA to whichever framework or frameworks govern.
Who bears liability and insurance for trial subjects?: Under the HFG, the person who initiates a research project involving people is liable for damage suffered by participants in connection with the project (Art. 19 HFG), and that liability must be adequately secured by insurance or in another form (Art. 20 HFG). A clinical trial agreement allocates these duties between sponsor and site: who procures and maintains trial-subject insurance, who indemnifies whom, and how product-liability and protocol-deviation risk are apportioned. Mispositioned indemnities are among the most common defects the firm corrects.
What does a master CTA template deliver?: A master clinical trial agreement template is a pre-negotiated, reusable contract base that fixes the recurring positions (indemnity and insurance, intellectual-property ownership and licensing of trial results, publication rights and embargo periods, data protection under the DSG and the GDPR, budget and payment mechanics, and termination) so that each new trial requires only site-specific or protocol-specific changes rather than a full renegotiation. It shortens contracting cycles and keeps a sponsor's or site's positions consistent across a portfolio of trials.

Last updated: 2026-05-31

Discuss a clinical trial framework