DSG Drug Safety

Streamline Safety Recording and Reporting

DSG’s eCaseLinkTM Drug 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.

The DSG Drug Safety system enables medical monitors to electronically record the SAE form information received from a site. Fields read from DSG’s eCaseLink EDC system and pre-fill the online form, such as demographic information. Key events, dates and status are easily tracked. The system alerts the medical monitor to differences between the safety data entry form and data entered into eCRFs within the eCaseLink EDC system.

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The benefits of the Drug Safety System

DSG Drug Safety

The Drug 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 DSG Drug 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.