GCP Audits & Monitoring

Good Clinical Practice

Comprehensive GCP Audit & Monitoring Services

Our GCP audit and monitoring services ensure clinical trials are conducted in accordance with International Council for Harmonisation (ICH) guidelines and regional regulatory requirements. We provide end-to-end support from project initiation to final report.

Our seasoned GCP auditors bring deep expertise in clinical research operations, regulatory submissions, and data integrity — ensuring your studies meet the highest standards of quality and compliance.

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Service Breakdown

What's Included in GCP Audits

Project Management

CRO/Site Identification & Selection
Budget & Timeline Tracking
Study Design Support
Study Documents Review
Control Correspondence Management
Feasibility Studies
Audit Queries Resolution
Study-Specific Management Plans

GCP Audits

System & Facility Audit
GAP Audit
For Cause Investigation
Site Qualification Audit
Regulatory Compliance Audit

Clinical Monitoring

Clinical phase study integrity
Protocol adherence verification
Measurement quality assurance
Subject safety monitoring
Valid data collection oversight

Bioanalytical Monitoring (RTBA)

Method Development
Interference & Inference Testing
Method Validation
Robustness Assessment

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Our Other Services

GMP Audits GLP Audits QMS Consulting GxP Training