DSG Safety System
eCaseLink™ Drug Safety System
DSG’s eCaseLink Safety system streamlines the safety recording, reporting process, data entry on Serious Adverse Events (SAEs), and can store documents associated with the safety event that facilitate the generation and tracking of queries.
eCaseLink Safety enables medical monitors to record the SAE information received allowing manual data entry into forms, as well as completed specific fields mapped from the eCaseLink EDC system. The Drug Safety system alerts the medical monitor to differences between the safety data and the data entered into eCRFs within the eCaseLink EDC system.
- eCaseLink Safety System provides extensive tracking
- Online system records extensive tracking information about various safety events
- Records include the data and status of submission to the regulatory agencies
- Facilitates the generation and tracking of queries connected to the safety event
- Seamless uploading of documents regarding adverse events
The benefits of the eCaseLink Drug Safety System
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.
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 system can also facilitate the generation and tracking of queries associated with the safety event. The configurable workflow allows multi-level approval and collaboration within different departments and sites.