A network to support your projects
We provide contacts with investigating centers, from small-scale pilot studies guaranteeing feasibility and safety, to multicenter pivotal studies evaluating efficacy and safety.
Our expertise
As a facilitator, the network puts promoters in touch with associated experts and centers, who mobilize their skills and resources available within their institution:
- Design and regulatory management of clinical studies: methodological advice on drafting clinical protocols, regulatory set-up and funding research
- In the event of institutional promotion (promoter UHC member of the network / collaborative project): support in setting up partnerships and responding to calls for projects, regulatory and financial aspects, drawing up study protocols and documents, technical-regulatory dossier, administrative and financial management
- Study conduct: coordination and facilitation of access to investigator centers for logistical management of single- and multi-center studies, including recruitment and follow-up of healthy patients/volunteers, access to cohorts, management of biocollections (CRB), performance of specialized clinical and paraclinical examinations (ECG, imaging, invasive electrophysiology), management of clinical interventions and post-procedural follow-up.
- Data management & safety: access to expertise in eCRF, data management, quality control and monitoring
- Analysis & development: connection with specialists for meta-analyses, pharmaco-epidemiology, statistical analyses (SNDS), support for scientific and editorial development (study reports, publications, medico-economic models, articles).
- Methodological and scientific support: scientific, technical, regulatory expertise/consultancy & access to training (medical device marketing, quality management, biological evaluation, clinical investigation, regulation)
To find out more, visit the page dedicated to our fields of application.
With 17 partner establishments involving 18 clinical departments, 4 Clinical Investigation Centers - Technological Innovation (CIC-IT) and 2 University Hospital Institutes (IHU), REFeR-RYTHMO facilitates access to multidisciplinary teams made up of cardiologists, project managers, CRAs, TECs, clinical research nurses, laboratory engineers and technicians, data managers, biostatisticians...for clinical expertise.
Conducting clinical research with integrity, including more, faster and better
Choosing REFeR-RYTHMO means benefiting from a one-stop shop, designed to simplify and accelerate the implementation of clinical trials involving medical devices in interventional rhythmology.
The network offers you a centralized gateway, able to quickly identify and access the centers best suited to your project, based on their expertise, equipment and recruitment capacity.
When you call on REFeR-RYTHMO, you benefit from:
- Fine knowledge of the clinical field, capitalized on on a national scale to optimize the recruitment and follow-up of healthy patients/volunteers.
- Centralized coordination, to streamline exchanges, reduce delays and rapidly mobilize qualified personnel.
- A common reference system, guaranteeing greater harmonization of practices between participating centers.
<⚠️ Many of our network members are proficient in the norms and standards applicable to medical devices and clinical trials, including:
- ISO 14155 (Good Clinical Practice for Medical Devices)
- ISO 62366-1 (Ergonomics and Usability of Medical Devices)
Contact & first exchange
Do you have a project, an idea or need some advice?
We offer a free initial exploratory exchange to assess together the relevance of an accompaniment.
📩 Get in touch with our team or, even better, fill in the project form.