eDRS™ at a Glance
The EDRS has been part of the endpoint application portfolio since 2013, however, will experience a large upgrade as part of the 2.0 release.
Moving from a protocol level system with limited functionality, the latest release of EDRS expands into a central solution for ticket and support management with extensible automated changes, blinding control, and the robust capability to manage documentation.
eDRS offers the ability to:
- Manage Trial Supplies on a Program Level
- Access Everything in One Portal
- Apply to all Trial Types
- Reduce Waste
- Manage Regulatory Requirements
- Make Complex Tasks Easier
- Improve the Patient Experience
- Access Experienced Clinical Supplies Professionals
- Minimize Paper-based Applications
- Contribute to a Healthy Environment
Manage all tickets across all endpoint applications from one sleek new user interface. Facilitate a multi-communication system where a user can contract support via the application, voice, or email for ticket logging. Increased capabilities include the ability to manage attachments, rich-text comments, and the user assignment workflow with integrated SLA capabilities.
Manage all scripts across all endpoint applications from one central repository. The application has the ability to create, review, and approve scripts within a controlled data management workflow. Script Copy and Versioning allows script history and re-usability to gain efficiencies and control over the repository. Increased automated data changes provide the ongoing ability to help facilitate rapid maintenance of endpoint applications.
Data Change Management
Continuously utilize validated scripts to maintain control of your study data. Permission driven functionality allows study specific data change workflows to give sponsor ultimate control over their data. All changes are reviewed, processed, and tracked from the inputs down to the audit record.
Regulations & 21 CFR PART 11
All functionality is permission driven and blind controlled in order to ensure that the right individuals maintain the right information without compromising the system blind. Full audit trail integration ensures that all changes are directly tracked into the audit trail in order to maintain change reasons for all data updates.
All core system functionality is blinded controlled and fully integrated into the endpoint environment. Tickets, Scripts, Data Changes, Attachments, and any free-text entry has the blind set or derived from the user role. The system then manages visibility rules and content distribution based on the blind of the user and the metadata associated.
A ticket system integrated directly into the endpoint product portfolio allows for robust reporting and tracking of issues across all studies. The centralized nature of the EDRS ensures that it is easy to track, trend, and analyze support tickets and data changes across your sponsor, program, or individual study to help address and facilitate site and study compliance.
The ticket is backwards compatible with version 1.0 of the endpoint EDRS system. This allows a seamless transition for our end-users to log and manage tickets without changing individual protocols or their legacy applications. The support team will be able to interface with the clients via the new application with data flowing into the older version of the application via a two-way API integration.