Safety management of a clinical research project starts well before study participants are recruited. It involves anticipating likely scenarios, implementing risk mitigation measures, and then following the process through to its conclusion. We provide safety expertise and create training, tools, and templates for safety considerations and reporting in clinical research. Our tools help clinical research professionals to never lose sight of the participants directly involved and to adhere to the complex regulatory requirements in this field.
Keeping an eye on the risk-benefit ratio of a clinical research project
- What we offer:
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We provide our combined safety expertise to everyone involved in the safety management of a clinical research project. We develop safety training, establish useful tools for safety management, and bring your questions to the right safety expert within our platform.
- What challenges we tackle:
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Safety is paramount in clinical research, and there are many people involved in safety management. Moreover, definitions of events, reporting processes and obligations, and templates differ depending on the type of trial. These diverse responsibilities can be challenging to handle for a clinical research team. We provide solutions that address these different scenarios.
- Our key projects:
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We have co-developed online safety training on patient safety and reporting matters in clinical research for investigators and clinical study staff members.
Show more Show lessFurthermore, we have created templates for reporting serious adverse events (SAEs) in ways that are in accordance with the requirements of the Swiss authorities swissethics and Swissmedic.
Our skills matrix indicates whom to contact with questions regarding specific key areas of pharmacovigilance and safety-related topics.
The minds behind the Safety Platform
We are safety experts working within academic clinical research who join efforts to develop training, tools, and templates for safety measures and reporting in clinical research projects. With the CTU-EOC as the responsible CTU for coordinating the safety platform, our activities also benefit from the close connection and collaboration with the Regional Pharmacovigilance Centre of Southern Switzerland.
Coordinator
Elena Porro
Ente Ospedaliero Cantonale (EOC)
CTU Lugano
Team
Elena Porro, CTU-EOC Lugano, Coordinator
Heidi Baumgartner, SAKK
Emilien Breat, CRC Lausanne
Laurène Cagnon, CRC Lausanne
Klaus Ehrlich, DKF Basel
Elke Hiendlmeyer, CTU St.Gallen
Stephanie Maissen, SCTO
Kristina Stojkov, CTU Bern
Fabiana Tirone, CRC Geneva
More team members
Anastasia Posdorowkin, CTC Zürich
Get in touch with us
We are your primary contact point for safety topics in the field of clinical research in Switzerland. To receive competent answers to general safety questions, contact us useing the form below.