CLINICAL DATA MANAGEMENT
A clean database for the statistical analysis and submission to regulatory authorities is one of the crucial aspects of a clinical trial. SPARC Consulting offers different software solutions for data collection, cleaning and reporting by always applying fully validated systems and providing clean scientific data in compliance with regulatory requirements. The choice of the tool is based on the complexity of the study and on the client’s requirements. To ensure a high quality level and the integrity of clinical we work closely with the sponsor to define the project’s needs and apply established standard operating procedures.
SPARC Consulting has a back-up and a disaster recovery system to ensure that all data remain confidential and safe.
Our data management services include:
- CRF design, printing and annotation (conventional, CDASH, or SDTM compliance)
- Database design and study setup
- Data entry for paper-based studies
- Electronic case report form (eCRF) design
- Data validation and query resolution
- Medical coding using MedDRA and WHO-DD dictionaries or client specific dictionaries
- Serious adverse events reconciliation
- Laboratory data handling
- CDISC study data tabulation model mapping in partnership with a certified provider
- Database transfers (conventional and CDISC formats)