We have a unique CRO profile providing unique and innovative dual expertise combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
Data Management
Clinical Data Management Services
Popsicube-Fovea offers full data management capabilities either in support of our clinical trials or as a service in support of clinical trials run by other organizations.
We perform data management using various electronic datamanagement programs.
Data Management Services:
- Data Management Planning
- CRF design, completion instructions, printing management and distribution
- eCRF implementation, tailor made customisation, validation under Gamp5
- CRF annotation
- Data Validation Planning
- Database structure Set-up
- Program and validate the data validation checks and loading process
- CRF and DCF tracking
- Query or Data Clarification Form set-up, generation, resolution and tracking
- Independent double data entry and discrepancy resolution
- Concomitant drug (WHO Drug Dictionary) Coding
- Adverse event, diagnoses and indication (MedDRA) Coding
- Automated validation checks and manual CRF review
- Bio-captors data injection and management
- Data transfers in all required format (SAS, CDISC, SDTM, …)
- Status reporting
- Clinical and Pharmacovigilance SAE (serious advert events) database reconciliation,
- CRF to database QC
- Database lock and Data Management Report
