Regulatory procedures require a sound knowledge of current legislations and regulations. We have chosen to assign a specially trained person to this task. Our senior pharmacist has extended hands-on experience as a clinical research associate and a project manager. She closely monitors developments in legislation and regularly participates in training on clinical research regulations. She also acts as Euraxi’s data protection officer (CIL) and has a thorough understanding of health data protection.
We manage all the regulatory submissions sponsors are required to make to the different instances in France (CPP, ANSM, CNOM, CCTIRS, CNIL, etc.).
– Initial submissions
– Submissions relating to amendments or modifications made while the project is underway
Our expertise encompasses all types of projects:
– Biomedical research
– Interventional research for routine care
– Observational studies
– Care practices surveys
– ATU (compassionate use) & RTU (off-label use)
– We handle regulatory submissions, for all types of contract, made to the different French National Councils of Professionals (CNOM, CNOP, etc.)
– We offer different contract models (direct services, healthcare establishment, civil servant, etc.) and adapt them to your project
– We can establish subcontracting for you with all clinical research actors (investigator, healthcare establishments, etc.)
– We undertake the negotiation of additional hospital costs and, if sponsors require it, we apply the contrat unique (French template agreement) measure
– We carry out the transparency declarations that laboratories must submit via the Site Internet Unique (one-stop health sector transparency website)
We take on a steadfast advisory role for the duration of your projects.
You benefit from our experience in dealing with different instances to give each new project the best start.
We are always quick to respond, making sure the regulatory process runs smoothly and enabling you to set up your projects in no time.
Euraxi has its very own data protection officer (CIL) registered with the CNIL (French data protection authority).
Our data protection officer is available to assist you with submissions and obligations related to the declaration process.
Thanks to our regular contact with the CNIL, we can advise you on the all the procedures required for health data protection.
Regulatory affairs training
All Euraxi staff are informed of regulatory updates via a periodic watch system.
They also take part in regular internal training sessions on clinical research regulations.
In addition to internal requirements, we also organise theme-based training (clinical research regulations, initiating ATUs (compassionate use) & RTUs (off-label use), clinical evaluation of medical devices, etc.) to meet the needs of our clients.