Clinical Research Compliance
Regulatory alignment for clinical research: study design, consent processes and clinical research agreements.
R&D Regulation, Navigated with Confidence
We help research-driven organizations comply complex regulations in clinical trials, secondary data use and AI-enhanced research. We combine deep expertise with legal clarity you can act on.
Research regulation is fragmented and constantly changing
Clinical trials, secondary data use and AI-enhanced research each carry their own regulatory regime - GDPR, the EU AI Act and sector-specific laws often apply simultaneously, and rarely align cleanly.
Non-compliance can mean material fines, market restrictions and severe reputational damage. Missteps can block data access or derail funding and partnership discussions.
In a constantly changing field, upholding trust of the research participants, partners and investors is crucial.
Our services
Ensure Responsible Innovations
Data Governance
Assessment of lawful basis, secondary use and complex cross-border transfers of sensitive data.
AI-enhanced Research
Compliance support for AI tools used in study design, analysis or diagnostics.
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Frequently asked questions
Is there a R&D exemption under the EU AI Act?
The EU Artificial Intelligence Act includes a specific research exemption. The AI Act does not apply to AI systems or models (or their outputs) that are developed and used solely for the purposes of scientific research and development.
This exemption may apply, for example, to academic prototype development or the training of a model intended solely for research use. However, the exemption no longer applies once an AI system is placed on the market or when it is no longer used exclusively for research or development purposes. Real-world testing is also subject to additional requirements.
Importantly, even when the AI Act does not apply, other applicable regulations must be complied with (e.g. GDPR, CTR, MDR).
What is the research exemption under the GPDR?
The General Data Protection Regulation (GDPR) provides certain flexibilities for processing personal data in scientific research, often referred to as the research exemption.
In practice, this allows existing data to be reused for scientific research without necessarily obtaining new consent, as scientific research is considered compatible with the original purpose of collection. In specific circumstances, certain data subject rights (such as the right to erasure) may also be restricted for research purposes.
However, these exemptions can only be relied upon when appropriate safeguards are implemented and the activity qualifies as genuine scientific research.
Additional regulations (EHDS, national laws) may also impose additional requirements for personal data processing and secondary use.
What agreements are needed in a research project?
In research projects, it is essential to document key terms in a written agreement. Core areas to address include the project implementation, data protection, confidentiality, intellectual property rights and liability.
The appropriate agreement depends on the scope of the collaboration, the parties involved and the applicable legislation. Some funders also require the use of their own contract templates.
Common types of research agreements include:
- Non-Disclosure Agreement (NDA): used before initiating collaboration, unless confidentiality is covered elsewhere
- Consortium Agreement: particularly common in academic and EU-funded collaborative research
- Material Transfer Agreement (MTA): required when biological materials or other samples are transferred between parties
- Clinical Trial Agreement (CTA): required for clinical drug or medical device studies
- Data Transfer Agreement (DTA): used when datasets are transferred as part of the collaboration.