Regulatory Affairs

Keeping clinical research projects on the right legal track

What we offer:

We keep track of the ever-changing regulatory environment and publish reviewed information for clinical research professionals. We identify challenges in the realm of clinical research regulatory affairs and interact with stakeholders to find the best solutions. In addition, we provide useful tools and guidance documents for smooth processes and for successful ethics and authority approvals.

What challenges we tackle:

Investigators and sponsor-investigators often see regulatory aspects as hurdles impeding clinical research. We aim to offer advice to stakeholders and support to clinical research professionals so that RA activities serve instead as a guarantor of quality and a smooth approval process.

Our key projects:

We regularly publish Regulatory Affairs Watch, our online journal addressing Swiss RA topics for clinical research professionals, investigators, sponsors, regulators, members of ethics committees, professional organisations, and patient associations.

We follow up on current developments as they occur, for example the use of electronic health records (EHR) as source data for case record forms in Switzerland, and we organise roundtables with swissethics and Swissmedic and suggest revisions to documents and templates.

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