Data Management
Clinical Data Management: data integrity, traceability, and reliability
At Centaur Clinical CRO, we provide rigorous, secure clinical data management that complies with international standards to ensure data integrity, traceability, and reliability throughout your clinical trials.
Key point
Rigorous clinical data management: integrity, traceability, and complete audit trail
Our clinical data management teams operate in accordance with GCDMP and 21 CFR Part 11 standards, ensuring reliable, reproducible, and auditable data.
Thanks to robust processes and close coordination with clinical, statistical, and pharmacovigilance teams, we reduce the risk of bias and secure statistical analysis timelines.
Our areas of activity
Scope of clinical data management
- eCRF (EDC) design and CRF specifications
- Data cleaning and continuous data review
- MedDRA/WHO-Drug coding
- Cross-data review (clinical, safety, statistics)
- Query management & reconciliations (PV, laboratories, imaging)
- Quality control and compliance GCDMP / ALCOA-C / 21 CFR Part 11
A structured approach
Our clinical data management methodology
eCRF design & setup
- CRF specifications
- eCRF construction
- UAT & validation rules
Data collection, review, and cleaning
- Query management
- Listings & reconciliations
- Continuous data review
Base lock and exports
- Secure database lock
- SDTM/ADaM exports
- Preparation for statistical analysis
Regulatory expertise
Clinical data management deliverables
The documents
- Data management plan (DMP)
- Data validation plan (DVP)
- eCRF & annotated CRF
- Data listings
- SAS/SDTM/ADaM exports
- Database lock file
I have a project
Centaur Clinical supports you at any stage of the Technical Documentation (TD) and the Quality Management System (QMS)
We support manufacturers throughout the CE certification process with the Notified Body.
Testimonials
What our satisfied customers say about us
We are starting a clinical investigation with Centaur Clinical and are very satisfied with our collaboration so far. Preparing the submission to the authorities is a stressful and time-consuming process that requires qualified personnel. The Centaur Clinical teams are always on hand to provide us with their expertise, availability and support.
Centaur Clinical helped us define a rationale and a clinical investigation strategy that was robust and consistent with the expectations of health authorities regarding the application of the RDM and the clinical evidence required.
