Maintaining 48-Hour Coding Timelines Across More Than 1,000 Adverse Events
At a Glance
Client: ValidcareIndustry:
Clinical Research Organization (CRO)
Challenge: Maintain real-time safety reporting continuity during an active, US-based, IRB-approved interventional study spanning more than 40 sites and 400 participants while adapting to intra-study regulatory requests from the FDA.
Solution: PiVOT rapidly onboarded to Validcare’s proprietary reporting platform, provided MedDRA and WHO Drug coding support, and worked closely with the study team to maintain operational continuity while responding to evolving study requirements.
Results:
- Cleared encoding of 500+ adverse events for initial engagement
- Maintained 48-hour coding turnaround times
- Processed more than 1,000 adverse events
- Completed MedDRA and WHO Drug coding requirements
- Maintained sponsor confidence throughout the study
The Challenge: Maintaining Safety Reporting Continuity and Regulatory Flexibility
Validcare was managing an active, US-based, IRB-approved interventional study spanning more than 40 clinical sites and over 400 participants. As the trial progressed, the team needed a safety reporting solution that could respond to intra-study regulatory requests from the FDA while maintaining uninterrupted adverse event coding. The study relied on real-time adverse event reporting through Validcare’s proprietary platform. As continuous reports entered the system, it was essential to maintain a consistent 48-hour coding turnaround times while retaining the flexibility to respond to evolving regulatory requests. Any delay in processing could affect study operations, making timely and accurate MedDRA coding for AEs and SAEs, together with precise WHO Drug Dictionary categorization, essential for maintaining compliance, patient safety, and study continuity.The Solution: Restoring Pharmacovigilance Continuity Across Systems and Time Zones
To support the project, Validcare partnered with PiVOT for pharmacovigilance services. PiVOT rapidly onboarded to Validcare’s proprietary reporting platform and aligned with existing workflows, enabling the team to begin supporting coding activities with minimal disruption. The collaboration focused on three key objectives:- Maintain continuous 48-hour coding turnaround times for incoming reports
- Deliver accurate MedDRA coding for AEs and SAEs alongside complete WHO Drug Dictionary categorization
- Respond efficiently to intra-study regulatory requests
The Results: Maintaining 48-Hour Coding Timelines Across More Than 1,000 Adverse Events
The partnership helped Validcare maintain operational continuity and safety reporting performance throughout the study. Key outcomes included:More Than 500 Adverse Events Cleared
PiVOT successfully worked through the initial batch of adverse events, allowing the study team to restore coding capacity and maintain reporting continuity.Consistent 48-Hour Coding Timelines Maintained
Once the initial batch was addressed, incoming adverse events continued to be coded within the required 48-hour turnaround time.More Than 1,000 Adverse Events Processed
Over the course of the project, the team supported coding activities for more than 1,000 adverse events.Adapted to Intra-Study Regulatory Requests
In addition to MedDRA coding, PiVOT completed WHO Drug coding requirements while supporting Validcare’s ability to respond to intra-study regulatory requests without interrupting study operations.Continued Sponsor Confidence
Throughout the project, safety coding remained on track and did not become a concern for the sponsor or regulators.What Validcare Had to Say
“PiVOT’s team is very knowledgeable and responsive. They are a pleasure to work with and we look forward to working with them on future projects.” – Validcare
Why Responsive Pharmacovigilance Support Matters
Safety reporting timelines cannot pause as study requirements evolve. Validcare’s experience shows how the right pharmacovigilance partner can help maintain reporting continuity, adapt to intra-study regulatory requests, and support sponsor confidence throughout active study operations.Need Pharmacovigilance Support?
Whether you need support for clinical trial safety reporting, MedDRA coding, WHO Drug coding, or post-marketing pharmacovigilance activities, PiVOT helps sponsors and CROs maintain compliant, responsive safety operations when it matters most.Connect with PiVOT to learn how our team can support your pharmacovigilance needs.
