 Data quality and integrity are the key components of your clinical trial. To ensure accuracy and usability of clinical data, FB2D can assist you in validation, management and quality assurance of your database management system (DBMS):
- CRF design and CRF completion guidelines
- Data Management plan, including edit-checks definition, patient profile, data coding and reporting
- SAE reconciliation processes
- Database validation according to 21CFR Part 11 and your SOPs
- Data quality control
- DBMS audit
Accuracy, Integrity and Quality are key to studies success.
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