Does GAWEL Legal act for the sponsor or for the site?

Either, on a per-engagement basis. GAWEL Legal 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 Germany, Austria and Switzerland, and for Swiss biotech sponsors of EU trials. Representation is limited to one party in each engagement; GAWEL Legal 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) for clinical trials and, for clinical trials of medical devices, the KlinV-Mep (Verordnung über klinische Versuche mit Medizinprodukten). A trial generally requires authorization by the competent cantonal ethics committee (Art. 45 HFG), and, where a therapeutic product is involved, additional authorization by Swissmedic under the therapeutic-products regime. Authorized 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); GAWEL Legal 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. The review includes whether the indemnities reflect that allocation.

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 keeps a sponsor's or site's positions consistent across a portfolio of trials.

Clinical trial contracting

GAWEL Legal negotiates clinical trial agreements (CTAs) for sponsors and sites under the HFG and the EU CTR, for a fixed fee each or on a framework retainer. The volume-based framework retainer covers CTA review and negotiation for either side, regulatory queries and reusable master-CTA templates, with a fixed fee per agreement.

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Terms of a clinical trial agreement

Indemnity and insurance: Allocation between sponsor and site
Research results: IP and publication rights
Trial operations: Data protection and payment terms

Advice for the sponsor or the site, with one party represented per engagement

Who this is for

Cantonal and university hospitals running investigator-initiated trials
Mid-size contract research organizations (CROs) contracting across Germany, Austria and Switzerland
Swiss biotech sponsors of clinical trials run in the EU
Device manufacturers contracting clinical investigations and post-market clinical follow-up studies

Scope

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 authorization regime (Art. 45 HFG) and the public-registration duty for authorized 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
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 the work proceeds

Scoping The first step confirms the party represented, the trial's jurisdictions, and whether the work covers a single CTA, a portfolio, or a master template.
Review The agreement is marked up against the client's position and the governing framework: the HFG and KlinV in Switzerland, the EU Clinical Trials Regulation for EU trials, and for device investigations the KlinV-Mep and the MDR.
Negotiation Contested terms, including indemnity, insurance, IP, publication and budget, are negotiated with the counterparty.
Master template Where one is in scope, the agreed terms are recorded in a reusable template for future trials.
Ongoing support Successive CTAs are handled against the agreed framework on the retainer, at a fixed fee per agreement.

Fees

Fixed fee per agreement; framework retainer for repeat work

A single agreement is a fixed fee on its own. For repeat work, a framework retainer runs alongside the per-CTA fixed fees for a full negotiation or a master-CTA template.

Questions

Does GAWEL Legal act for the sponsor or for the site?: Either, on a per-engagement basis. GAWEL Legal 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 Germany, Austria and Switzerland, and for Swiss biotech sponsors of EU trials. Representation is limited to one party in each engagement; GAWEL Legal 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) for clinical trials and, for clinical trials of medical devices, the KlinV-Mep (Verordnung über klinische Versuche mit Medizinprodukten). A trial generally requires authorization by the competent cantonal ethics committee (Art. 45 HFG), and, where a therapeutic product is involved, additional authorization by Swissmedic under the therapeutic-products regime. Authorized 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); GAWEL Legal 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. The review includes whether the indemnities reflect that allocation.
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 keeps a sponsor's or site's positions consistent across a portfolio of trials.

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