Data Management
At WEP, we leverage the industry’s most trusted and widely used Electronic Data Capture (EDC) systems to provide seamless, efficient, and regulatory-compliant data management for your clinical trials. Our end-to-end data management services ensure accurate, real-time data collection, validation, and reporting to help you achieve faster study initiation and successful regulatory submissions.
EDC System Selection & Customization
- We assist sponsors in choosing the most suitable EDC system based on trial complexity, data volume, trial type, data sources and regulatory requirements.
- Our Data Management team builds and customizes eCRFs (electronic Case Report Forms) to ensure efficient data collection, protocol adherence, and ease of use for investigators.
Real-Time Data Collection & Integration
- Seamless site data entry via intuitive eCRFs that ensure accurate and efficient data collection.
- Integration with ePRO/eCOA (Patient-Reported Outcomes), wearable devices, central lab data, and other external data sources for comprehensive data capture.
- Multi-site, multi-region, and multi-language capabilities for supporting trials across different geographies.
Data Cleaning & Validation
- Automated edit checks and real-time query resolution are used to ensure clean, consistent, and complete datasets.
- AI-powered data discrepancy detection helps identify anomalies and inconsistencies early, preventing costly delays.
- Data reconciliation across multiple sources (EDC, IVRS/IWRS, safety databases) to ensure accuracy.
Risk-Based Monitoring (RBM) & Quality Oversight
- Real-time dashboards & advanced analytics provide instant visibility into enrollment progress, site performance, and protocol deviations.
- AI-driven Risk-Based Monitoring (RBM) strategies ensure that data anomalies and site compliance issues are flagged early.
- Remote monitoring capabilities reduce the need for frequent on-site visits, improving efficiency and reducing costly travel expenses.
Compliance & Regulatory-Ready Data Management
- Fully compliant with FDA, EMA, MHRA, and Health Canada requirements.
- 21 CFR Part 11-compliance for complete transparency and data integrity.
- Preparation of submission-ready datasets formatted per CDISC SDTM & ADaM guidelines to ensure smooth regulatory approval.
Secure & Scalable Data Management
- Role-based access control (RBAC) and encrypted data storage for enhanced confidentiality.
- Cloud-based and decentralized trial solutions, ensuring accessibility from anywhere while maintaining data security.
WEP’s Expertise in Leading EDC Platforms
At WEP, we are certified experts in the most popular Electronic Data Capture (EDC) systems, ensuring sponsors have access to the best technology for their trial.| EDC System | Key Features | Best Suited For |
|---|---|---|
| Medidata Rave | Advanced reporting, AI-driven analytics, CDISC compliance | Large global trials, complex data requirements |
| Veeva Vault EDC | Unified clinical data environment, automated workflows | Fast-moving trials, mid-sized biotech & pharma |
| Merative Zelta | AI-powered insights, intuitive interface | Multi-country trials, adaptive study designs |
| REDCap Cloud | User-friendly setup, cost-effective for small studies | Early-phase trials, Expanded Access Programs, registry trials, open-label extensions, academic research, decentralized studies |