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Safety

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:

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:

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:

We have co-developed online safety training on patient safety and reporting matters in clinical research for investigators and clinical study staff members.

Furthermore, 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.

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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

Elena Porro, CTU-EOC Lugano, Coordinator

Heidi Baumgartner, SAKK

Heidi Baumgartner, SAKK

Laurène Cagnon, CRC Lausanne

Laurène Cagnon, CRC Lausanne

Alessandro Ceschi, CTU-EOC Lugano

Alessandro Ceschi, CTU-EOC Lugano

Klaus Ehrlich, DKF Basel

Klaus Ehrlich, DKF Basel

Elke Hiendlmeyer, CTU St.Gallen

Elke Hiendlmeyer, CTU St.Gallen

Stephanie Maissen, SCTO

Stephanie Maissen, SCTO

Anastasia Posdorowkin, CTC Zürich

Anastasia Posdorowkin, CTC Zürich

Kristina Stojkov, CTU Bern

Kristina Stojkov, CTU Bern

Fabiana Tirone, CRC Geneva

Fabiana Tirone, CRC Geneva

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.