Data Management
Data Management
At GRC, we ensure meticulous care throughout every stage of data management, ensuring that all data points are reliable, verifiable, and accurately reflect the trial’s progress. With extensive experience in handling clinical trial data, our tailored, performance-driven approach guarantees that our clients receive high-quality, clean data within the required timelines.
We develop comprehensive study documentation to outline all steps of the data management process, including specific procedures such as the Data Management Plan (DMP), Data Validation Plan (DVP), validation checks specifications, SAE reconciliation, and medical data coding. Our Data Management Services include:
- Design/Development of Case Report Form (CRF)
- CRF Annotation
- Development of the Data Management Plan (DMP) and Data Handling Procedures
- Database Design (EDC Platform), Development, and User Acceptance Testing (UAT)
- Development of the Data Validation Plan (DVP)
- Double Data Entry, Automated Double Data Comparison, and Synchronization
- Electronic and Manual Discrepancy Identification and Automated Data Queries (ADQ) Generation
- AE/SAE Reconciliation and Reporting
- Identification and Tracking of Protocol Violators
- In-stream Patient Closure and Quality Control Auditing
- Database Lock
- Final Archiving and Imaging
By providing a comprehensive and systematic approach to data management, GRC ensures that every trial is supported by accurate, high-quality data, enabling timely decision-making and regulatory compliance.