GCP Audit Coverage

Protocol Adherence:

Ensure that clinical trials are conducted according to the approved protocols.

Informed Consent Processes:

Review the processes used to obtain informed consent from the trial’s participants.

Investigational Product Handling:

Audit investigational for product storage, dispensing and accountability.

Adverse Event Reporting:

Ensure compliance with adverse event monitoring and reporting protocols.

Data Management:

Evaluate data collection, management, and reporting practices for consistency and accuracy.

Monitoring Procedures:

Assess the effectiveness of clinical trial monitoring procedures

Good Clinical Practice (GCP) Covers

Good Clinical Practice (GCP) is an international quality standard that governs the design, conduct, performance, and reporting of clinical trials. It ensures that the rights, safety, and confidentiality of trial participants are protected, and that the trial data is accurate, reliable, and credible. GCP compliance is essential for obtaining regulatory approval and conducting ethical research.

GCP Audit Approach

Initial Assessment & Planning

We start by reviewing trial protocols, regulatory requirements, and your business objectives to develop a tailored audit plan.

On-Site/Remote Audits

Our experts conduct thorough audits at trial sites, focusing on protocol adherence, informed consent, data integrity, and investigational product management.

Review & Analysis

We examine all trial-related documentation, monitoring reports, and adverse event records to ensure compliance with GCP guidelines and accurate data handling.

Risk Identification & Mitigation

Potential risks in the trial process are identified, and we provide actionable recommendations to address them, ensuring regulatory compliance and trial integrity.

Compliance Reporting

We deliver detailed audit reports, highlighting key findings, areas for improvement, and solutions to resolve non-compliance issues.

Follow-up & Continuous Monitoring

After the audit, we provide post-audit support to monitor the implementation of corrective actions to ensure continued GCP compliance throughout the trial.

Achieve the highest standards in your clinical trials with UMED’s GCP services. Protect patient safety, maintain integrity, and achieve regulatory compliance with confidence.