Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
PV
Pharmacovigilance Support
We provide comprehensive safety monitoring support—from SAE case processing to DSUR preparation—ensuring patient safety and regulatory compliance throughout your trials.
Comprehensive Pharmacovigilance Support
We handle the entire safety reporting process on behalf of your organization—from SAE case processing through DSUR preparation. Our experienced PV team integrates with your clinical operations to ensure timely, compliant safety reporting that protects patient safety and meets regulatory obligations.
As your PV support partner, we bring deep expertise in safety regulations, medical terminology, and global reporting requirements to manage all aspects of trial safety monitoring and documentation.
Our approach
How We Support Your Safety Reporting
- 01
Case Receipt & Triage
We receive SAE reports, perform initial triage, and coordinate with medical reviewers for causality assessment and expectedness determination.
- 02
Case Processing & Documentation
We prepare detailed case narratives, enter data into safety databases, and ensure regulatory-compliant documentation with all required elements.
- 03
Regulatory Reporting Support
We assist with expedited report preparation, submission tracking, and correspondence with regulatory authorities per global requirements.
- 04
Periodic Reporting
Throughout the trial, we support DSUR/PSUR preparation, safety updates, and ongoing compliance with safety reporting obligations.
Deliverables
What You Receive
SAE Case Reports
Complete, medically reviewed case narratives with all regulatory elements properly documented and QC’d.
Expedited Reports
Regulatory-compliant expedited safety reports prepared and submitted within required timelines.
Database Entries
Accurate safety data entry into your safety database with independent quality control checks.
Safety Tracking
Real-time SAE logs showing case status, reporting deadlines, and outstanding action items.
DSURs/PSURs
Comprehensive annual or periodic safety reports compliant with global regulatory requirements.
Compliance Documentation
Complete audit trails and documentation supporting regulatory inspection readiness.
Why Prequel
The Prequel Advantage
Faster Processing
24-48h SAE turnaround meets tight regulatory timelines and ensures patient safety.
Regulatory Compliance
Deep expertise in global safety reporting requirements including ICH, FDA, EMA, and DCGI.
Quality Focus
Independent QC on all safety documents ensures accuracy and completeness before submission.
Database Experience
Proficiency across major safety systems including Argus, Oracle, and ARISg.
By The Numbers
- 24-48h SAE Processing Time
- 100% On-Time Reporting
- 15+ Years PV Expertise
*Indicative benchmarks from programs we supported as an FSP/vendor; outcomes reflect combined client+vendor execution. Final commitments are documented in the SOW/WO.
When you need us
Common Scenarios
High SAE Volume
Trial experiencing significant SAE volumes requiring additional processing capacity to meet regulatory timelines.
Multiple Markets
Global trial needs coordinated safety reporting across multiple regulatory authorities with varying requirements.
Resource Gaps
Internal PV team lacks capacity for both routine and expedited safety activities across multiple trials.
Database Support
Need for safety database entry and quality control support to maintain accurate safety data.
Related support services
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Clinical Data Management Support
EDC/eCRF build & validation, DMP/edit checks, coding, queries, freeze/lock support.
Ready to Strengthen Your Safety Monitoring?
Let’s discuss how our pharmacovigilance support can help you maintain patient safety and regulatory compliance.