CRO · Clinical Data & Research · France

Your clinical data under control

A human-scale French CRO specialised in biostatistics, data management and proprietary technology solutions for your clinical trials.

+18ansd'expertise scientifique
+7000dossiers patients gérés
HDS · CDISCconformité FDA & MDR
11+langues déployées
Expertise & Solutions

4 areas of expertise, one single team

Data Management

CDMS configuration, monitoring, MedDRA coding, locked database ready for analysis.

ExagisMedDRAWHO-Drug
+7,000 patients managed

Biostatistics

Statistical analysis plan, randomisation, interim and final analyses under SAS.

SASRCDISC
100% CDISC standards

Tech Solutions

Exagis CDMS, patient ePRO, randomisation, turnkey HDS hosting.

ExagisePROHDS
11+ languages deployed

Clinical Operations & Support

Methodology, protocol writing, CPP/ANSM submission, publication support.

Support investigateur-promoteurMDRPMCF
+18 years of advisory
THE SOLUTION

Exagis, our
integrated platform.

A proprietary platform compliant with GAMP5 and CDISC, flexible and scalable. Three modules working in concert to manage your clinical trials, from patient data collection to the final report.

  • CDMS data capture, randomisation, quality control, real-time reporting
  • HDS hosting · 11+ languages · 7,000+ patient files managed
  • Designed for academic sponsors, biotechs and small pharma
COMPLIANCEHDSCDISCGAMP5FDA
01

Proprietary CDMS platform

Electronic data capture, randomisation, integrated quality control and real-time reporting. 11+ languages, HDS hosted, CDISC compliant.

7,000+patient files managed
02

ePRO — Live patient data

Automatic collection via electronic forms (smartphone, tablet, PC). Works offline, facilitates decentralised trials.

98%patient completion rate
03

REPORT Module — Autonomous management

Real-time visualisation: recruitment, SAEs, missing data, targeted extractions. Automated newsletter templates for your investigators.

24/7dashboard access
Methodology

From the first discussion
to database lock

A mastered 4-phase process. At every step you know who does what, when, and with which deliverables.

01

Scoping

Protocol, scope, constraints, kick-off with your dedicated point of contact.

02

Set-up

Exagis CDMS configured, analysis plan, databases, randomisation.

03

Conduct

Enrolment, monitoring, ePRO, MedDRA coding, continuous quality oversight.

Analysis

Database lock, SAS biostatistics, CDISC deliverables, final report.

MEDTECH PARTNER · 4 STUDIES
Axiodis enabled us to meet ambitious timelines across two simultaneous Phase III trials. Their responsiveness and the quality of the data delivered were decisive for our EMA submission.
R&
R&D Director
Mid-size company · Implantable medical device · France
4 studiescompleted
+3 yearspartnership

They trust us

Pierre Fabre
Avène Laboratoire
Inserm
Institut Pasteur
Institut Bergonié
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