Clinical Data Management Services
In clinical research, data integrity and accuracy are paramount. Genelife Clinical Research excels through its robust Data Management Department. With an unwavering commitment to quality and accuracy, our department plays a pivotal role in the success of clinical development programs for clients working with a CRO in India.
99.9%+ Data Accuracy — Genelife's remarkable accuracy levels consistently exceed 99.9%, confirmed through both internal and external database audits with near-zero error rates across all clinical trials.
Data Management Capabilities
- CRF Design, Production, and Tracking (Paper & Electronic)
- Database Design, Build, and Validation
- Electronic Data Capture (EDC) System Management — 21 CFR Part 11 compliant
- Data Entry, Validation, and Query Management
- CDISC SDTM and ADaM Dataset Preparation for regulatory submissions
- Data Listings, Tables, and Figures Generation
- Medical Coding using MedDRA and WHODrug dictionaries
- Database Lock Procedures and Quality Control
- Long-term Data Archival and Regulatory Compliance
Technology Platform
Electronic Data Capture (EDC)
Validated, real-time EDC system with 21 CFR Part 11 compliance, comprehensive audit trails, and remote access for investigators and sponsors globally.
eDocumentation Control
Centralized, version-controlled document management system ensuring all study documents are current, accessible, and compliant with regulatory requirements.
Genelife Clinical Research deploys a fully validated EDC system ensuring real-time data access, complete audit trails, and 21 CFR Part 11 compliance for all clinical trial data generated by this CRO in India.