Good Clinical Practice (GCP) Audits

Good Clinical Practice (GCP) audits are independent reviews of clinical trial operations and documentation to verify adherence to regulatory and ethical standards. They help ensure participant safety and data integrity by checking everything from protocols and consent forms to data management. RxCloud offers GCP auditing as part of our GxP Audits portfolio, enabling sponsors and CROs to identify compliance gaps early and minimize risk in their trials.

RxCloud’s GCP audit scope is comprehensive and tailored to your trial’s needs. We review all critical elements of trial conduct – for example, informed consent procedures, protocol compliance, investigational product handling, adverse event reporting, and data quality. The scope and depth of the audit are defined collaboratively during planning, following ICH GCP guidance on what to audit and how.

All GCP audits at RxCloud are conducted by independent, highly trained auditors. By GCP guidelines, auditors must be independent of the trial and qualified by experience. Our global audit team meets this standard: every auditor is a certified expert with extensive experience in clinical research and GxP regulations, ensuring each audit is performed with in-depth regulatory knowledge.

RxCloud’s GCP audits adhere to all relevant global regulations and standards. We base our audits on ICH E6 (Good Clinical Practice) and applicable FDA, EMA and other regulatory requirements, ensuring full compliance with protocol, SOPs and laws. In addition, RxCloud is ISO 9001:2015 certified, underscoring our commitment to international quality and compliance standards throughout the audit process.

We follow a structured, multi-phase audit process: initial planning and scope definition, on-site or remote audit execution, and reporting/close-out. The exact timeline varies by trial complexity and number of sites, but our global presence allows efficient scheduling. Clients have noted that RxCloud delivers “timely audits” with worldwide coverage. (All audits follow the sponsor’s written procedures on scope and reporting, per ICH GCP requirements.)

After the audit, you receive a comprehensive audit report. The report includes an executive summary and detailed findings (noting any critical deviations or observations) along with supporting evidence. All audit observations and findings are fully documented, and we include recommended corrective actions with guidance for your corrective-action plan. A formal audit certificate of completion is also provided when appropriate.

Confidentiality is a top priority for RxCloud. All audits are performed under strict non-disclosure agreements, and audit data is handled using secure systems. RxCloud’s ISO 9001:2015 certification reflects our robust quality-management processes, which include data security and privacy safeguards. We ensure that access to sensitive information is strictly controlled and that audit findings are shared only with authorized stakeholders.

Yes. We help clients address any issues identified during the audit. RxCloud assists with developing and implementing corrective-and-preventive action (CAPA) plans and can perform follow-up reviews if needed. Our robust audit management system tracks all findings through resolution, and our auditors remain available to advise on remediation and to verify that compliance improvements are fully implemented.