The Strategic Importance of DSUR Drafting and Submission Challenges : Best Practices for Clinical Trials for the US, EU & UK
The DSUR Drafting and Submission process is the cornerstone of safety reporting during the clinical trial phase. An annual Developmental Safety Update Report (DSUR) ensures that regulators are kept informed of the evolving risk-benefit profile of an investigational drug.
Drafting for Regulatory Approval
Successful DSUR Drafting and Submission requires a meticulous review of all safety data collected during the reporting period. This includes data from both interventional and non-interventional studies.
Common Challenges in Aggregate Reporting:
- Data lock point – Drafting and quality review with the DLP
- Submissions within timelines
- Health authority enquires
- Quality
The biggest challenge in DSUR Drafting is ensuring that data from all global sources (US, EU, UK & APAC) is thoroughly analyzed within the tight submission windows requires world-class Quality management.
As a Strategic Partner, we assist and deliver high quality reports for MAHs and Sponsors in their DSUR, PSUR and PBRER Drafting to ensure 100% submission compliance with very minimal health authority inquiries.
Watch our video on DSUR explained video for more details: https://youtu.be/FdQl0Xk4Awk
Have a look at our service page on how we address the challenges and Connect with us for inquiries – Contactus@globalplacosolutions.com
For clinical trials aiming for Regulatory approvals, the DSUR must be synchronized with your Global Pharmacovigilance Strategy.