Data Management - eSource
ClinEdge’s Remote-Based Monitoring Platform utilizes a site electronic source and regulatory system that can be interfaced within a sponsor's clinical trial platform. In addition to being Part 11 compliant, this platform allows for easy access to each site’s source documents, query management, and direct communication between site staff and monitor. This platform will allow for increased study visibility and eliminate paper-based documents.
Making your trial more accessible
ClinEdge offers a unique service that can be added to manage and oversee remote-based monitoring of clinical trials. Paper source can be managed through our portal and new trials can be launched leveraging the already-established site eSource platform, thereby effectively minimizing the onboarding timeline.
eSource Technology Integration
Easy access to site’s source documents through the use of eSource technology at the site level
Remote-Based Monitoring
Direct communication through the portal between site and monitor
Rapid Startup
Sites are able to startup quickly and receive CRA training with ongoing support
Multiple Options to Fit Your Trial’s Needs:
Enterprise Level
- Protocol Review
- Source Built Based on Requirements
- Site Training on eSource
- Weekly Reporting
Prime Level
- Training on Remote-Monitoring Platform
- Customized Templates Built Based on Study Source
- Site Training on eSource
- Weekly Reporting
Compliance:
Meets strict GDPR requirements
Part 11 compliant
Access to a global compliance team with expertise in each country’s local laws
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