SUSAR and DSUR Submissions

Client Challenge
A Clinical Research Organization (CRO) managing multiple global clinical trials faced challenges in preparing and submitting SUSARs (Suspected Unexpected Serious Adverse Reactions) and DSURs (Development Safety Update Reports). The client struggled with tight deadlines, complex regulatory requirements, and the need to ensure consistency across multiple trials and regions. They required a partner to streamline the process and ensure compliance with global pharmacovigilance regulations.

PVigi’s Solution
PVigi provided end-to-end support for SUSAR and DSUR submissions, ensuring timely and compliant reporting. Our approach included:

SUSAR Processing and Submission

DSUR Preparation and Submission

Regulatory Expertise

Efficient Workflow Management

Training and Support

Outcome
Timely Submissions: All SUSARs and DSURs were submitted within regulatory deadlines, avoiding potential penalties.

Regulatory Compliance: The client achieved full compliance with global pharmacovigilance regulations for clinical trials.

Improved Efficiency: Standardized workflows and advanced tools reduced the time and effort required for SUSAR and DSUR preparation.

Enhanced Safety Oversight: The client gained a clearer understanding of the safety profiles of investigational products, enabling proactive risk management.

Client Satisfaction: The CRO praised PVigi’s expertise and support, leading to a long-term partnership.