Quality Unit
Services
The Quality Unit (UQ) of CRC, independent of the Clinical Investigation Unit (UIC) and the Methodological Support Unit (UAM), works for continuous improvement of the quality of clinical trials.
Several services are offered:
• Implementation or optimization of a quality management system for the conduct of clinical trials (QMS)
• Preparation for inspection by a regulatory authority (eg Swissmedic, FDA or EMA). UQ can prepare a search team before an inspection and provide support during its progress.
• Performing a clinical study audit, at the request of the sponsor or investigator-sponsor
Within HUG, the UQ is mandated by the General Directorate and the Medical Directorate to perform audits of clinical trials sponsored by the HUG and / or carried out at the HUG.The Quality Unit (UQ) works to continuously improve the quality of how clinical trials are conducted.
Clinical trials run by an investigator/sponsor may be inspected by Swissmedic and incur fees. We offer a coverage guarantee: Swissmedic Inspection Fees Coverage Guarantee - Conditions and Enrollment
Employees
- Isabelle Semac, PhD, Research Assistant - Head of Quality Unit
Mobilie: 079 55 35 617 - Tel.: 022 372 91 95
isabelle.semac@hcuge.ch
- Isabelle Mercier, PhD, Research Assistant
Tel.: 022 372 91 32 isabelle.mercier@hcuge.ch
- Véronique Ménoni, PhD, Research Assistant
Mobile: 079 55 30 917 -Tel.: 022 372 91 95 veronique.menoni@hcuge.ch
- Marlène Anthoine Mischler, Administrative Secretary
Tel.: 022 372 91 57marlène.mischler@hcuge.ch
Contact
contact.crc@hcuge.ch
isabelle.semac@hcuge.ch
Mobilie: 079 55 35 617 - Tel.: 022 372 91 95