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 trial. Our end-to-end data management services ensure accurate, real-time data collection, validation, and reporting, helping you achieve faster study timelines and successful regulatory submissions.
Key Features of WEP’s EDC-Enabled Data Management Services
- EDC System Selection & Customization
- We help sponsors choose the most suitable EDC system based on trial complexity, data volume, 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, ensuring accuracy and efficiency.
- Integration with ePRO/eCOA (Patient-Reported Outcomes), wearable devices, and central lab data for comprehensive data capture.
- Multi-site, multi-region compatibility, supporting trials across different geographies.
- Data Cleaning & Validation
- Automated edit checks and real-time query resolution to ensure clean, consistent, and complete datasets.
- AI-powered data discrepancy detection helps identify anomalies 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.
- Compliance & Regulatory-Ready Data Management
- Fully compliant with FDA, EMA, MHRA, and Health Canada requirements.
- 21 CFR Part 11-compliant audit trails for complete transparency and data integrity.
- Preparation of submission-ready datasets in CDISC SDTM & ADaM formats for smooth regulatory approval.
- Secure & Scalable Data Management
- ISO 27001-certified security protocols ensure protection against data breaches.
- 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 |
| Oracle InForm | Real-time data entry, high-level security, seamless integration | Phase II-IV trials, oncology & rare disease studies |
| Veeva Vault EDC | Unified clinical data environment, automated workflows | Fast-moving trials, mid-sized biotech & pharma |
| IBM Clinical Development | AI-powered insights, intuitive interface | Multi-country trials, adaptive study designs |
| Castor EDC | User-friendly setup, cost-effective for small studies | Early-phase trials, academic research, decentralized studies |