It is based on the study of new drugs, medical devices, therapies or medical procedures, evaluating their efficacy, safety and impact on patient health. It plays a crucial role in advancing medical knowledge and enabling the development of new therapeutic solutions.
Gepromed, thanks to its location at the heart of Strasbourg's University Hospitals and its close collaboration with the Vascular Surgery, Renal Transplantation and Innovation Department, is dedicated to ensuring quality follow-up of the department's studies, as well as supporting surgeons and/or manufacturers in the development of their clinical investigations on medical devices.
What we offer
Gepromed offers its services and designs specific solutions for all players in the healthcare system in compliance with MDR EU 2017/745. Today, our area of expertise focuses mainly on implantable medical devices (IMDs) for vascular surgery. We can act as a CRO for your clinical projects, pre- and post-CE marking, for all or part of your study:
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Defining needs and objectives | Study design | Regulatory submissions |
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Study management (quality control, invoicing, meeting deadlines, etc.) | Analyses des données et rédaction des rapports |
Here you'll find the full range of services offered by Gepromed.
Don't hesitate to contact us at recherche.clinique@gepromed.com, and an expert will get in touch with you as soon as possible.
Team
Nina RAMON (Clinical Study Technician, CST): attached 100% to the Vascular Surgery Department, she is responsible for implementing the studies in the department in accordance with the protocol validated by the regulatory authorities. She is responsible for patient follow-up, data collection, updating investigator documents, and will be your main contact for monitoring visits.
Manon RUHLMANN (Clinical Research Associate, CRA, and coordinator): working closely with the project manager, she plays an active role in setting up projects and ensuring compliance with the laws and regulations applicable to your projects (RDM EU 2017/745, ISO 14155 standard, GCP). She will be responsible for the administrative and logistical follow-up of the centers taking part in the investigation, carrying out set-up, monitoring and closing visits.
Laura ROTH (Project manager): she will be your main contact at the start of the project, identifying your needs, guiding you in classifying your project and proposing a suitable action plan. Under your supervision, she will design the regulatory file and manage the entire project to meet your objectives and regulatory requirements (RDM EU 2017/745, ISO 14155, GCP).