Our panel of Clinical Data Management services includes :
Protocol development/review support.
e-CRF design / e-PRO design (Web or Mobile Application)
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.
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

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

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.