Data Management

Our panel of Clinical Data Management services includes :

Protocol development/review support
e-CRF design
Paper CRF design and printing
CRF completion guidelines
Development of project documentation: Data Management Plan, Data Entry
Conventions, Data Cleaning/Validation Plan, Data Management Report…
Generation of annotated CRFs following sponsor/4Clinics standards
Database design and set-up
Database validation with dummy patients
Data extraction, mapping, and pooling
CRF tracking
Data entry (double or interactive mode)
Data cleaning: programming checks and testing, query management
Medical preferred term coding (MedDRA, WHOdrug)
Release of patient profiles and listings
Conducting medical reviews
Data quality control
External data uploading (ECG, Ct-Scan, MRI, lab results, drug levels concentrations, PK data, etc.)
SAE reconciliation between the safety database and the clinical database.
Protocol deviations: definition, detection, and evaluation
Regular reporting: metrics, study status
Randomization list management
Participation in the data/blind review meeting
Database lock (interim and final lock)
Data transfers
DM study file maintenance and archiving

Consultancy Support & Staffing Solutions

From years of experience, 4Clinics Data Management teams offer expertise in various clinical tools :

  • Clintrial
  • ENNOV Clinical - Clinsight
  • SAS
  • EDC and RDC tools, such as Merge and Marvin

4Clinics uses ENNOV Clinical and Clintrial to provide fully-integrated EDC, IWRS, and medical coding solutions. All solutions are robust and validated according to CFR Part 11. ENNOV Clinical is compatible with electronic or paper-based CRFs.

The 4Clinics Data Management team can guide you through the implementation of the CDISC-SDTM and CDISC-CDASH global standards to ensure consistency across different projects.