Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Pharmacovigilance Support
We provide comprehensive safety monitoring support—from SAE case processing to DSUR preparation—supporting patient safety and regulatory compliance throughout your trials.
Comprehensive Pharmacovigilance Support
We support the safety reporting process on behalf of your organization—from SAE case processing through DSUR preparation—under your safety SOPs and oversight. Our experienced PV team integrates with your clinical operations to support timely, compliant safety reporting against your regulatory obligations.
As your PV support partner, we bring a working knowledge of safety regulations, medical terminology, and reporting requirements to support 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 document each case with the required regulatory 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
Case narratives prepared for medical review, with the regulatory elements documented and QC’d.
Expedited Reports
Expedited safety reports prepared and tracked against the required reporting timelines, for submission by the sponsor, or by us where authorised.
Database Entries
Accurate safety data entry into your safety database with independent quality control checks.
Safety Tracking
Up-to-date SAE logs showing case status, reporting deadlines, and outstanding action items.
DSURs/PSURs
Annual or periodic safety reports prepared to the applicable regulatory requirements.
Compliance Documentation
Complete audit trails and documentation supporting regulatory inspection readiness.
Why Prequel
The Prequel Advantage
Run to the Regulatory Clock
Case processing is run to the regulatory clock, with turnaround defined in your safety plan.
Regulatory Compliance
Working knowledge of safety reporting requirements, including ICH, CDSCO (NDCT Rules, 2019), US FDA and EMA.
Quality Focus
Independent QC built into safety documents before submission, checking accuracy and completeness.
Database Experience
Experience across commonly used safety databases; the specific systems are confirmed during scoping.
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 strengthen your safety reporting and regulatory compliance.