Clinical Data Management
Clinical Data Management team works with sponsors and exhibits well timed, accurate, highest standard clinical trial data, making you take a prompt and more effective decisions regarding to the safety, tolerability and PK |PD properties.
This team handles both paper and EDC on all standard industry platforms. 21 CFR Part 11 compliant integrated service | stand-alone data management support on Oracle Clinical® v5.1 with RDC platform or remotely through a secure, direct-access connection to your clinical data management system.
Services includes but not limited to
- Project Specific Clinical Data Management Plan
- Customized Database Design & Development
- Independent Double‐Data Entry
- Design pCRF / eCRF
- Develop CRF completion guidelines
- Query Management
- Medical Coding, SAE Data Reconciliation
- Edit, Validation and Design check
- Programming
- Data Validation, Data Migration, Data Loading, Data Cleaning
- Database Testing & UAT
- Quality Control and Data Quality Audits
- Database Lock and Export to SAS
- Project Data Archival and Storage
- Documentation CDM Report.