Multicentre Phase II/III oncology trial — CDMS setup in 5 weeks
A European oncology biotech, 14 investigator sites in 4 countries, dual FDA and EMA submission planned.
5 wks
from signature to go-live
14
investigator sites activated
98%
completion rate
0
critical observations
The challenge
Setting up an international multicentre CDMS within 5 weeks, compliant with FDA 21 CFR Part 11 and EMA standards, for a Phase II/III oncology trial with 14 sites in 4 countries.
The context
A European oncology biotech needed to launch a multicentre Phase II/III clinical trial. With a limited in-house team, it was looking for a CRO partner capable of taking over complete data management, from CDMS configuration through to database delivery.
Implementation with Axiodis
Weeks 1–2: Scoping & CDMS configuration
Analysis of the protocol and assessment endpoints (overall survival, progression-free survival, RECIST criteria). Configuration of CDMS forms on Exagis, validation rules, conditional branching. Drafting of the DMP and annotation guide.
Weeks 3–4: UAT & site training
User acceptance testing (UAT) with the sponsor team. Training of investigator CRAs and site coordinators. Progressive deployment across the 14 sites in the 4 countries.
Week 5: Go-live
Go-live across all sites. Dedicated support during the launch period. First-level query resolution.
Ongoing monitoring
Real-time data monitoring, query management, weekly quality reports to sponsor, database lock preparation.
Results at 6 months of operation
Go-live in 5 weeks
CDMS go-live across all 14 sites within 5 weeks of contract signing.
98% completion rate
Data completion rate at 6 months of operation, above the protocol-required threshold.
0 critical observations
No critical observations raised during the regulatory audit conducted by the competent authority.
Real-time management
Sponsor dashboards accessible in real time, queries resolved within 48 hours on average.
“The Axiodis team adapted to our tight timelines while maintaining an impeccable level of quality. Their Exagis CDMS enabled us to centralise all our data and manage the trial in real time. A partnership we will renew.”
Director of Clinical Operations
European biotech, oncology
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