GCP Audits

Overview

Good Clinical Practice (GCP) audits help ensure that clinical trials are conducted ethically, scientifically, and in accordance with applicable regulatory requirements, approved protocols, and quality standards.

Mediature GxP Solutions Pvt. Ltd. (MGS) provides independent GCP audit services for clinical trial sites, sponsors, CROs, investigators, and other organizations involved in clinical research.

Our audits assess the systems, processes, documentation, and controls that support participant safety, protocol compliance, data integrity, investigational-product accountability, and reliable clinical-trial conduct.

MGS follows a practical, risk-based approach to help clients identify compliance gaps, improve clinical quality systems, and maintain readiness for sponsor and regulatory inspections.

Our GCP Audit Services

Clinical Trial Site Audits

Assessment of investigator sites, study conduct, source documentation, informed consent, protocol compliance, investigational-product handling, and essential records.

Sponsor System Audits

Evaluation of sponsor oversight, trial governance, quality management, monitoring, safety reporting, vendor management, and study documentation.

CRO Audits

Assessment of outsourced clinical-research activities, quality systems, operational controls, documentation practices, and contractual responsibilities.

Investigator Site Qualification Audits

Pre-study assessment of site capabilities, facilities, personnel, processes, documentation systems, and readiness to conduct clinical trials.

Trial Master File / Essential Document Audits

Review of essential clinical-trial documentation for completeness, accuracy, traceability, and compliance with applicable GCP requirements.

Informed Consent Process Audits

Evaluation of informed-consent documentation, participant communication, consent timing, version control, and protection of participant rights.

Investigational Product Accountability Audits

Assessment of receipt, storage, dispensing, reconciliation, return, destruction, temperature control, and documentation of investigational products.

Clinical Data & Source Documentation Audits

Review of source records, case-report forms, electronic systems, data traceability, corrections, audit trails, and clinical data-integrity controls.

Pre-Inspection & Mock GCP Audits

Simulated regulatory inspections to identify gaps and prepare clinical teams, sites, sponsors, and CROs for upcoming inspections.

Key GCP Audit Focus Areas

Depending on the audit scope, MGS may assess:

• Investigator qualifications and responsibilities
• Participant rights, safety, and well-being
• Informed consent process
• Ethics committee / IRB documentation
• Protocol compliance
• Source documentation
• Case-report forms
• Essential trial documents
• Trial Master File management
• Investigational-product accountability
• Safety reporting
• Adverse event documentation
• Monitoring and oversight
• Vendor and CRO management
• Data management
• Electronic systems
• Data integrity
• Deviations and corrective actions
• Training and competency
• Record retention and archiving
• Quality management systems
• Sponsor oversight
• Inspection readiness

Applicable GCP Perspective

Depending on the trial, jurisdiction, and client requirements, audit criteria may consider applicable requirements and expectations associated with:

• ICH E6 Good Clinical Practice
• Applicable national clinical-trial regulations
• Sponsor and protocol requirements
• Ethics committee / IRB requirements
• Data-integrity expectations
• Applicable electronic-record requirements
• Other relevant clinical-research guidance and regulatory expectations

The final audit criteria are defined according to the study design, responsibilities, and regulatory environment.

Our Audit Process

• Define Scope

Understand the study, site, sponsor/CRO responsibilities, applicable regulations, protocol requirements, and audit objectives.

• Prepare

Review available trial documents and prepare a risk-based audit plan focused on critical clinical and quality-system elements.

• Conduct

Perform on-site or remote assessment through interviews, document review, source-record verification, process evaluation, and system review.

• Evaluate

Assess observations based on their potential impact on participant safety, data integrity, protocol compliance, and regulatory requirements.

• Report

Provide a clear audit report with observations, supporting evidence, compliance significance, and areas requiring improvement.

• Follow Up

Where required, support CAPA review, remediation, effectiveness assessment, and follow-up audits.

GCP Audit Deliverables

Depending on scope, MGS can provide:

• Audit agenda and audit plan
• Site/system assessment
• Detailed GCP audit report
• Observation summary
• Risk-based observation classification
• Compliance-gap assessment
• CAPA review support
• Inspection-readiness recommendations
• Follow-up audit support

Why Choose MGS for GCP Audits

Independent Assessment

Objective third-party evaluation of clinical systems, sites, and processes.

Risk-Based Approach

Audit focus is directed toward areas with the greatest potential impact on participant safety, data reliability, and regulatory compliance.

Practical Findings

Clear observations that help clients understand the gap, its significance, and the areas requiring corrective action.

Flexible Audit Models

Support for routine audits, site qualification, sponsor oversight, CRO/vendor audits, pre-inspection readiness, and focused system assessments.

Cross-Functional Expertise

Access to professionals with experience across quality, regulatory, clinical, data-integrity, and computerized-system compliance.

Who We Audit

MGS can support GCP audits of:

• Clinical trial sites
• Investigators and research units
• Sponsors
• Contract research organizations
• Clinical vendors
• Data-management providers
• Electronic clinical-system providers
• Central laboratories
• Investigational-product depots
• Other critical clinical-trial service providers