Good Clinical Practice (GCP) Audits: Strengthening Clinical Trial Credibility
With our Good Clinical Practice (GCP) audits, we ensure that your suppliers adhere to global standards, minimizing risks in your clinical trials. Our audits enhance supplier quality and compliance, allowing you to focus on successful regulatory submissions and trial efficiency.
Our 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 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.
What is Good Clinical Practice (GCP) ?
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.
How is Good Clinical Practice (GCP) different from Good Laboratory Practice (GLP) & Good Manufacturing Practice (GMP)?
Here’s how we approach GCP Practices:
At RxCloud, our certified audit experts in 27+ countries approach Good Clinical Practice (GCP) audits through a comprehensive six-phase process to ensure full compliance and quality control:
Our GCP Audit Approach
1. Initial Assessment & Planning
We start by reviewing trial protocols, regulatory requirements, and your business objectives to develop a tailored audit plan.
2. On-Site/Remote Audits
Our experts conduct thorough audits at trial sites, focusing on protocol adherence, informed consent, data integrity, and investigational product management.
3. Review & Analysis
We examine all trial-related documentation, monitoring reports, and adverse event records to ensure compliance with GCP guidelines and accurate data handling.
4. 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.
5. Compliance Reporting
We deliver detailed audit reports, highlighting key findings, areas for improvement, and solutions to resolve non-compliance issues.
6. 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 RxCloud’s GCP services. Protect patient safety, maintain integrity, and achieve regulatory compliance with confidence.
Contact us today to streamline your GCP processes
and stay ahead in your compliance journey!