Management of Clinical Trials - Clinical Trials Set-up and Conduct (2025)

Micro-credential

The micro-credentialed Short course Clinical Trials Set-up and Conduct corresponds to module 7 of the DAS in Management of Clinical Trials.

• Understand scientific, strategic, and safety considerations in clinical trial design.
• Develop budgets and plan resources effectively for clinical trials.
• Select appropriate investigator sites for trial implementation.
• Identify the role of Contract Research Organisations (CROs) and external providers in clinical trial management.
• Familiarise with essential clinical trial documents and their significance in trial conduct.
• Navigate the submission process to Swiss Ethics Committees (EC) and Regulatory Authorities (RA).
• Implement risk management strategies to ensure trial safety and compliance.

Professionals involved in clinical trial management, including clinical research coordinators, project managers, regulatory affairs specialists, and individuals responsible for trial set-up and conduct.

• Proficiency in designing clinical trials considering scientific, strategic, and safety aspects.
• Ability to develop and manage budgets for clinical trial operations.
• Skill in selecting investigator sites based on strategic criteria and operational feasibility.
• Understanding of the roles and responsibilities of CROs and external providers in clinical trial management.
• Competence in preparing and managing essential clinical trial documents.
• Proficiency in navigating the submission process to Swiss Ethics Committees and Regulatory Authorities.
• Ability to implement risk management strategies to mitigate potential risks during trial conduct.

Director(s)

Prof. Youssef DAALI and Prof. François CURTIN, Faculty of Science and Faculty of Medicine, University of Geneva

The course is accredited by Swissethics, Swiss Association of Pharmaceutical Professionals (SwAPP), Swiss Society of Clinical Pharmacology and Toxicology (SGKPT-SSPTC), Swiss Institute for postgraduate and continuous medical education (SWIF-ISFM).

a) Holders of a university master’s degree or doctorate in science, medicine or pharmacy or a qualification deemed equivalent;
or a bachelor’s degree in nursing from a Swiss University of Applied Sciences;
or a qualification deemed equivalent or professional experience deemed equivalent by the programme directors.

b) Good oral and written comprehension of English (equivalent to level B2-C1)

• Prof. Gerrit Borchard, President of the Section of Pharmaceutical Sciences (ISPSO), Faculty of Science, University of Geneva
• Prof. Alexandra Calmy, Vice-Dean of clinical research, Director of the Clinical Research Centre (CRC), Head of HIV/AIDS Unit, Associate Physician, Department of Infectious Diseases, Geneva University Hospitals
• Prof. Youssef Daali, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Prof. Antoine Geissbuhler, Dean of the Faculty of Medicine, University of Geneva
• Dr Olivier Huber, President, Cantonal Commission on Human Research Ethics, Canton of Geneva
• Prof. Samia Hurst, Director, Institute of Ethics, History and Humanities (iEH2), Faculty of Medicine, University of Geneva
• Prof. Arnaud Perrier, Medical Director, Geneva University Hospitals

• Dr Emilie Alirol, Senior Director Clinical Affairs, FIND
• Dr Enrica Alteri, Pharmaceutical consultant, former Head of Human Medicine R&D Support Division, EMA
• Prof. Francois Curtin, Medical Director Personalised Health Programmes, Swiss Federal Institute of Technology in Zürich & Lecturer at Geneva University Hospitals, University of Geneva
• Prof. Youssef Daali, Head of the Pharmacological Investigation Unit, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Dr Patricia Delaite, Chief Medical Officer, Nouscom, Basel
• Dr Catherine Deloche, Chief Operating Officer, Solid Drug Development, Geneva
• Prof. Jules Desmeules, Faculty of Medicine, University of Geneva
• Prof. Philippe Ducor, Faculty of Law, University of Geneva
• Prof. Marc Froissart, Full Professor Clinical Research, Faculty of Biology & Medicine - FBM, UNIL, Lausanne
• Prof. Angèle Gayet-Ageron, Head of the Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals, Faculty of Medecine, University of Geneva
• Prof. Angela Huttner, Associate Professor, Department of Infectious Diseases, Geneva University Hospitals, Faculty of Medicine, University of Geneva
• Dr Cyril Jaksic, Statistician, Methodological Support Unit, Clinical Research Centre (CRC), Geneva University Hospitals
• Dr Françoise Lascombes, External Consultant
• Dr Guillaume Perriard, PhD, Lead patient Engagement, Novartis, Basel
• Dr Victoria Rollason, Division of Clinical Pharmacology and Toxicology, Geneva University Hospitals and Faculty of Medicine, University of Geneva

• Copy of identity document
• Passport photo
• Curriculum Vitae
• Copies of relevant university degrees
• Covering letter
• Two reference letters
• Written authorisation from their employer, if applicable