From CDMS to database lock, quality first.
Data management plan, CDMS configuration on Exagis, monitoring and database lock. CDISC compliant, hosted in France (HDS).
All of data management, under one roof
Data Management Plan (DMP)
Drafting of the Data Management Plan covering the entire data lifecycle, from collection through to database lock.
Exagis CDMS Configuration
Configuration of the CDMS on our proprietary Exagis platform: forms, validation rules, conditional branching.
Monitoring & data review
Centralised data review, query management, real-time sponsor dashboards.
Medical coding
Coding of verbatim medical terms using MedDRA and WHO Drug Dictionary, with coder review and up-to-date dictionaries.
SAE reconciliation
Reconciliation between Serious Adverse Events in the CDMS and pharmacovigilance data.
Database lock
Database lock procedure: final review, resolution of outstanding queries, blind review, lock and archiving.
Our data management methodology
From design to lock, a proven process across 500+ studies.
Protocol scoping
Protocol analysis, identification of regulatory requirements, DMP drafting.
Exagis CDMS build
CDMS configuration, UAT with the sponsor team, validation prior to go-live.
Go-live & monitoring
Site opening, CRA and coordinator training, continuous query management.
Coding & reconciliation
MedDRA / WHO Drug coding, SAE reconciliation, final data cleaning.
Database lock & delivery
Blind review, database lock, CDISC SDTM/ADaM export, 15-year archiving.
Need a data management expert?
CDMS configuration, monitoring or database lock — let's talk.