Gravitas Biosciences Health, provides customer with centralized, coordinated data management services for local and international studies. We handle all phases of clinical research across the full spectrum of therapeutic areas. Gravitas Biosciences Health, develops flexible and customized data management plans to accommodate each customer specific study needs. We also offer customized reports to customers at timely and periodical intervals to get the complete feel of the conduct of study.
Study Set-up
- CRF Design
- eCRF Specification
- CRF Annotation
- eCRF build
- Data Management Plan
- Data Base Design & Setup
- Edit check specifications & Programming
- Data Loading Setup
- Dictionary setup (MedDRA, WHODD)
- IVRS/IWRS Integration
Study Conduct
- Data Review & Query Management
- Medical Coding
- SAE Reconciliation
- Third party Data Reconciliation (Central Lab, eDiary, Pharmacokinetics etc.)
- Post Production Change Control
- Data Base Design & Setup
- Standard & Customized Reports for Data review & Metrics
- Data Transfer
Study Close Out
- Interim analysis readiness
- Final DB lock readiness
- QC of Data Base
- Database Audit by QA
- Database Lock
- Conversion of Data to SDTM or sponsor standards
- Data Transfer
- Study closure Documentation
- Study Archival / Decommissioning