Exagis · ePRO · Turnkey HDS hosting.
Proprietary Exagis platform, patient ePRO application, centralised randomisation, HDS France hosting. GDPR, MDR, FDA 21 CFR Part 11 compliant.
An integrated, proprietary, compliant tech stack
Six technology components developed in-house, interoperable and compliant with European and American regulatory requirements.
Exagis CDMS
Proprietary CDMS platform, configured for each study. Intuitive interface, multilingual, full audit trail, CDISC export.
Patient ePRO (web + mobile)
Web and mobile patient application for the collection of patient-reported outcomes (PRO), available offline.
e-Consent
Electronic informed consent compliant with GDPR and ICH E6 R2, with qualified electronic signature and legal archiving.
IWRS randomisation
Integrated IWRS module for centralised randomisation, treatment and kit management, with stratification.
HDS France hosting
HDS-certified servers (Hébergeur de Données de Santé) on French soil, GDPR and ISO 27001 compliant.
21 CFR Part 11 audit trail
Complete traceability of all platform actions, certified timestamping, exportable for FDA and EMA inspections.
Regulatory compliance
Request an Exagis demo
30 minutes to discover the platform, work through a concrete case and see what can be tailored to your study.