Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
QA
Quality Assurance & Audits
From process audits to inspection readiness, we provide comprehensive QA support ensuring your trials maintain the highest standards of quality and regulatory compliance.
Comprehensive Quality Assurance Support
We support your organization across all quality assurance activities—from QA plan development through inspection readiness and audit execution. Our experienced QA professionals integrate with your operations to ensure trials meet GCP standards and regulatory expectations.
As your QA support partner, we bring deep expertise in ICH-GCP requirements, risk-based quality management, and inspection preparedness that protects trial integrity and ensures regulatory compliance.
Our approach
How We Support Your Quality Systems
- 01
QA Planning
We develop study-specific QA plans, identify critical processes and risks, and establish quality metrics for your trial.
- 02
Ongoing QA Activities
Throughout the trial, we perform document reviews, process audits, and provide guidance on GCP compliance and quality standards.
- 03
Audit Execution
We conduct scheduled audits, document findings with evidence, and work with your team to develop effective corrective actions.
- 04
Inspection Support
We assess inspection readiness, prepare mock inspections, and provide support during regulatory inspections as needed.
Deliverables
What You Receive
QA Plans
Comprehensive quality assurance plans tailored to your trial’s risk profile and complexity.
Audit Reports
Detailed audit findings with recommendations, risk ratings, and evidence documentation.
QC Checklists
Study-specific quality control tools for document review and process verification.
CAPA Tracking
Corrective action logs with implementation tracking and effectiveness verification.
Inspection Reports
Readiness assessments with gap analyses and recommendations for inspection preparation.
Training Materials
GCP and quality training resources customized for your organization and trial requirements.
Why Prequel
The Prequel Advantage
Inspection Readiness
Proactive QA ensures your trials are always audit-ready and prepared for regulatory inspections.
Risk-Based Approach
Focus on critical quality issues that matter most using ICH E6(R2) risk-based quality management principles.
Regulatory Knowledge
Expertise in ICH-GCP, DCGI requirements, and global quality standards for clinical trials.
Rapid Response
Quick turnaround on audit findings and CAPA development to maintain trial momentum.
By The Numbers
- 100% Audit Readiness
- 48h Finding Response Time
- 15+ Years QA Experience
*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
Inspection Preparation
Regulatory inspection scheduled and you need readiness assessment and gap closure support.
Quality Issues
Trial experiencing quality deviations requiring expert root cause analysis and CAPA development.
New Study Launch
Need QA plan development and quality process setup for new trial initiation and activation.
Resource Gaps
QA team lacks capacity for scheduled audits and quality oversight activities across multiple trials.
Related support services
Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Ready to Strengthen Your Quality Systems?
Let’s discuss how our QA support can help you maintain the highest quality standards and regulatory compliance throughout your trials.