eCaseLink – Drug Safety System
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eCaseLink Drug Safety System
Streamline safety recording and tracking queries
eCaseLink Safety system streamlines the safety recording, reporting process, and data entry for any Serious Adverse Events (SAEs), and can store documents associated with the safety event that facilitate the generation and tracking of queries associated with the safety event.
ICH E2B compliant and supports regulatory integration
The eCaseLink Safety System is designed to target safety data by capturing and comparing the data points required for a clinical trial study. The Safety System is ICH E2B compliant and provides user generation of FDA 3500A MedWatch and FDA 3500A CIOMS forms. The Safety System can be integrated with eCaseLink EDC, or setup as a stand-alone application, and can be integrated with other regulatory and clinical trial management systems.
Safety alerts and view SAE information
The Safety System enables medical monitors to record and view SAE information received from either a single case or can span multiple protocols. The Drug Safety system alerts the medical monitor if there are any differences between the safety data and the eCRF data that was entered from the eCaseLink EDC system.
DSG’s Drug Safety System features:
- Extensive safety event and patient tracking capabilities
- Records consist of safety data and status of submission to regulatory agencies
- Provides online system records and extensive tracking information for various SAE events
- Facilitates the generation and tracking of queries connected to a safety event
- Seamless uploading of documents specifically related to any adverse events
The benefits of the eCaseLink Drug Safety System
eCaseLink Safety
The eCaseLink safety system generates and tracks safety event queries and can be integrated with eCaseLink, or as a stand-alone application. The Safety system captures data using only the data points you need. It has a configurable workflow with a multi-level approval process that integrates with other regulatory and management systems. A user can view a single case or span across multiple protocols and easily generate tracking reports.
Data Capture of a Safety Event
An online data entry form facilitates the capture of extensive information about the safety event. User can generate an FDA 3500A MedWatch or CIOMS form containing the entered data.
Extensive Tracking
In addition, the eCaseLink Safety system can record extensive tracking information about the safety event, including the date and status of submissions to regulatory agencies. The DSG Drug Safety system makes it easy to upload documents associated to the adverse event, making it convenient to access critical documentation at any time. The configurable workflow allows multi-level approval and collaboration within different departments and sites.