Element’s Clinical Data Management services assist organizations to comply with global data standards (CDISC) by implementing best practices. It ensures that complete and reliable data is available for processing. To maintain regulatory compliance, there needs to be a greater aggregation of data. Greater aggregation of data and its reusability ensures accelerated drug development and reduces clinical research costs. Element’s customized approach drives consistency in the clinical data management process by ensuring compliance to standards while maintaining data quality and integrity.
We leverage industry standards for clinical data management, GCDMP guidelines that include best business practices and acceptable regulatory standards. With this, Element helps clients realize improved data quality, reduced data management costs, assure portability and accountability of data.
Element supports Electronic Data Capture (EDC) trial studies, paper studies and hybrid studies across various therapeutic areas on all major platforms available in the industry. We leverage our project management expertise and work with our data management experts to identify potential issues during a project and eliminate them before the occurrence.
Our Service Offerings:
- CRF / CDISC compliant Database design
- CRF Annotations
- Study setup and configuration
- Edit-check specifications and programming
- Validation procedures
- User Acceptance testing and multiple site rollouts
- Discrepancy management
- AE and SAE reconciliation
- External data load
- CDISC ODM compliant data transfers
- Database Lock and closeout
- Data extracts