Data Management and Biostatistics
Reliable, consistent, and high-quality data is crucial for clinical data management and a critical element of a Clinical trial. Therefore, data management is a vital component of our customer value proposition. Vibgyor has a skilled team of Data Management and Biostatistics associates, who are well trained and experienced. By adhering to ICH-GCP guidelines, Standard Operating Procedures, and 21 CFR part 11 compliant systems, our Data Management team provides comprehensive and tailored services right from Protocol Design to Database Lock to generate excellent and superior-quality error-free data to our Sponsor’s utmost satisfaction.
Our dedicated data team ensures that the data coming out of the investigative sites is of the highest quality possible. We have the experience, resources, and the expertise to take on this commitment without compromising on time, quality, and budget.
Vibgyor offer the following data management and biostatistics services:
Data Management
- Development of eCRF/CRF
- Paper-based or EDC Database Development and set-up
- Database documentation
- Database Validation, Edit Checks and Self Evident Corrections
- Data Cleaning and Query Management
- Remote Data Entry (RDE)
- CRF Log, Review, and Tracking
- Double Data Entry and Verification
- Audit Trail Generation
- Medical Coding (MeDRA and WHODrug)
- Expediting accurate, clean, and supportable study data
- SAE reconciliation
- Database lock, Transfers, and Archiving – interim, final (required format)
Biostatistics
- Study Design Development Sample Size Calculations
- Protocol Statistics
- Statistical Analysis Plans
- DSMB and CEC meetings, preparation, and attendance
- Statistical Reports