DXC's four-step process to help you support and comply with new ICSR rules.
As many life sciences companies know, the U.S. Food and Drug Administration (FDA) now requires digital submission of all Individual Case Safety Reports (ICSRs) for postapproval human drug and non-vaccine biologic products. While this requirement aims to improve public safety, compliance can be complicated, time-consuming and costly.
In addition, the ICSR requirements are strict. Faxing or mailing paper MedWatch forms is no longer permitted. Instead, all ICSRs must be submitted individually, and in XML format, to the FDA’s Adverse Event Reporting System (FAERS) database.
The FDA’s new ICSR rules come at a time when many life sciences organizations find themselves constrained by scarce resources. Fortunately, this is precisely where DXC can help. Our ICSR service covers the most time- and resource-consuming portions of the process: testing, transmission and tracking. DXC leverages its extensive experience to help clients customize their needs, depending on where they are in the process.
And we do this with our unique four-step process:
- ICSR Consulting and Assessment
- Create a Plan for Transmission and Tracking of ICSRs
- Develop and Test the Transmission and Tracking Processes
- Implement the Transmission and Tracking Processes for Production ICSR Submissions