Euraxi Pharma
Independent full-service contract research organization (CRO) founded in 1986, operating in France and Europe. Provides clinical research services for pharmaceuticals, medical devices, dermo-cosmetics and nutrition, including interventional and non-interventional trials (Phases I–IV), early-access and compassionate-use programs, decentralized/home-based trial services, data management & biostatistics, pharmacovigilance and regulatory support. Reported metrics on the site include 40+ years of activity, 130+ employees, 2,000+ projects, and 10,000+ home visits over five years.
Industries
N/A
Nr. of Employees
small (1-50)
Services
Comprehensive management from protocol development and regulatory submissions through monitoring, site management, data cleaning and final reporting for Phases I–IV and observational studies.
Selection, contracting, training and coordination of mobile nurses; home visit planning; IP and kit logistics; sample collection and couriering; waste management; home-visit QC and reporting.
Operational setup and running of early-access and compassionate-use schemes including regulatory filing support, DMP and PAS drafting, dedicated application modules, dashboards and pharmacovigilance.
Clinical evaluation reports (CER), investigations for CE marking, post-market clinical follow-up (PMCF), study design under ISO 14155 and MDR 2017/745 guidance, and interactions with notified bodies.
Data capture tool setup, data cleaning and validation (DOC/DEV/VAL), remote monitoring, statistical planning and analysis, and dashboard/dataviz implementation for study oversight.
Safety case management, narrative writing and preparation of periodic safety reports for authorities.
Comprehensive management from protocol development and regulatory submissions through monitoring, site management, data cleaning and final reporting for Phases I–IV and observational studies.
Selection, contracting, training and coordination of mobile nurses; home visit planning; IP and kit logistics; sample collection and couriering; waste management; home-visit QC and reporting.
Operational setup and running of early-access and compassionate-use schemes including regulatory filing support, DMP and PAS drafting, dedicated application modules, dashboards and pharmacovigilance.
Clinical evaluation reports (CER), investigations for CE marking, post-market clinical follow-up (PMCF), study design under ISO 14155 and MDR 2017/745 guidance, and interactions with notified bodies.
Data capture tool setup, data cleaning and validation (DOC/DEV/VAL), remote monitoring, statistical planning and analysis, and dashboard/dataviz implementation for study oversight.
Safety case management, narrative writing and preparation of periodic safety reports for authorities.
Expertise Areas
- Clinical trial management (Phases I–IV, non-interventional)
- Decentralized clinical trials and home-based clinical operations
- Early-access and compassionate-use program management
- Medical device clinical evaluation and regulatory strategy
Key Technologies
- Electronic data capture / Clinical data management systems
- GxP-validated ePRO platforms
- Secure health-data hosting (HDS)
- Data visualization / BI tools
News & Updates
Announcement of a new Belgium subsidiary to support home nursing and decentralized clinical trial activities; cited operational capabilities include nurse selection/contracting/training, centralized or local laboratory management, kit preparation, drug dispensing logistics, waste management and a project-management app.
Exhibitor presence announced for the AFCROs 'Journée de la Recherche Clinique' event; lists participation as exhibitor and stand information.
Protocol publication for the randomized multicenter ENDORAS Trial (robotic surgery for endometriosis) referenced on the site, indicating involvement in protocol publication and clinical research.
Article discussing the role of digital tools to secure and manage compassionate-use prescription frameworks (CPC) and associated pharmacovigilance and traceability requirements.
Article authored by a company medical writer on clinical operations and clinical evaluation of digital medical devices, available as a downloadable PDF.
Site reports EcoVadis recognition for the company's CSR commitments.
Announcement of a new Belgium subsidiary to support home nursing and decentralized clinical trial activities; cited operational capabilities include nurse selection/contracting/training, centralized or local laboratory management, kit preparation, drug dispensing logistics, waste management and a project-management app.
Exhibitor presence announced for the AFCROs 'Journée de la Recherche Clinique' event; lists participation as exhibitor and stand information.
Protocol publication for the randomized multicenter ENDORAS Trial (robotic surgery for endometriosis) referenced on the site, indicating involvement in protocol publication and clinical research.
Article discussing the role of digital tools to secure and manage compassionate-use prescription frameworks (CPC) and associated pharmacovigilance and traceability requirements.
Article authored by a company medical writer on clinical operations and clinical evaluation of digital medical devices, available as a downloadable PDF.
Site reports EcoVadis recognition for the company's CSR commitments.