At Clinical Research Audit, we offer comprehensive independent Good Clinical Practice (GCP) audits to help clinical investigative sites maintain compliance with regulatory requirements, ensuring that all clinical trial activities align with the highest standards of quality, ethics, and patient safety. Our independent audits are tailored to identify gaps, mitigate risks, and enhance overall site performance to ensure your clinical trial is fully prepared for regulatory inspections, such as those conducted by the FDA or IRB.
Key Features of Our Independent GCP Audit Services:
- Thorough GCP Compliance Review: Our audits involve a detailed assessment of your site’s adherence to Good Clinical Practice (GCP) guidelines. We evaluate everything from informed consent processes and patient safety protocols to data management practices and investigational product accountability, ensuring full compliance with ICH-GCP, FDA, and IRB standards.
- Protocol Adherence and Documentation Audits: We perform in-depth reviews of your trial’s protocol adherence, focusing on the proper implementation of study procedures and the accuracy of source documentation. Our team examines case report forms (CRFs), adverse event reporting, protocol deviations, and all other critical documentation to ensure completeness and compliance.
- Site Readiness for FDA/IRB Inspections: Our independent GCP audits prepare your clinical site for regulatory inspections by identifying any areas of non-compliance or potential risks. We provide detailed corrective action plans to address any deficiencies, ensuring that your site remains inspection-ready at all times.
- Auditable Findings and Corrective Action Plans: After the audit, we provide a comprehensive report outlining our findings, including any observed deficiencies or areas for improvement. We also offer a detailed corrective and preventive action (CAPA) plan to help your site resolve these issues promptly, minimizing risks and improving the quality of clinical trial conduct.
- Investigational Product Management: Our auditors evaluate the handling, storage, and accountability of investigational products, ensuring that they are maintained according to study protocols and regulatory requirements, thus reducing the risk of product mishandling and ensuring patient safety.
- Patient Safety and Data Integrity Focus: Patient safety and the integrity of clinical trial data are at the core of our GCP audits. We assess patient eligibility, safety reporting, and adherence to informed consent procedures to ensure that trials are conducted ethically, and the collected data is reliable and credible.
- Customizable Audit Scope: Our GCP audits can be customized to meet the specific needs of your clinical trial, whether you need a full trial audit or a targeted review of specific processes like patient consent, investigational product management, or data integrity. We work closely with your team to define the audit scope based on your trial’s unique challenges and requirements.
Why Choose Our Independent GCP Audit Service?
- Unbiased and Objective Audits: As an independent auditor, we provide an impartial, objective review of your clinical site’s operations, identifying any potential compliance issues without conflicts of interest.
- Experienced Auditors: Our team of seasoned GCP auditors brings years of clinical research and regulatory experience to ensure that your site meets the highest standards of quality and compliance.
- Regulatory Expertise: We stay up-to-date with the latest regulatory changes and guidelines to ensure that your clinical site is always compliant with evolving global standards, minimizing the risk of FDA Form 483 findings or other regulatory issues.
- Actionable Solutions: Beyond identifying deficiencies, we provide actionable, tailored solutions to address gaps in compliance, enhancing your clinical site’s performance and regulatory preparedness.
- By partnering with Clinical Research Pivot for independent GCP audits, your clinical investigative site will be better equipped to maintain compliance, protect patient safety, and produce high-quality, reliable clinical trial data.tailored plan to achieve your business goals.