As clinical trials become increasingly complex and global, the necessity for rigorous oversight has never been higher. Protheragen serves as a strategic partner to the global pharmaceutical industry, providing specialized third-party auditing services designed to mitigate risk and optimize site performance.
We offer expert phase II-IV clinical trial site audit services designed to safeguard your clinical data and ensure the highest standards of Good Clinical Practice (GCP) compliance. Our team of seasoned auditors provides an objective, independent evaluation of investigator sites, ensuring that trials are conducted ethically and that results are robust enough for regulatory scrutiny.
At Protheragen, we understand that an audit is not a mere box-checking exercise. It is a systematic, independent examination of trial-related activities and documents to evaluate whether the evaluated trial is conducted in accordance with the protocol, GCP, and applicable regulatory requirements. We provide a comprehensive suite of audit services tailored to the specific needs of your clinical development program.
Scheduled audits are conducted during the active phase of a trial to evaluate adherence to ICH GCP and applicable FDA regulations, as well as the approved protocol. These audits help sponsors fulfil their oversight obligations and detect operational drift before data quality is compromised.
A focused review of the informed consent process, including verification that valid signed and dated consent forms are on file for all enrolled subjects, that consent was obtained before any study-related procedures, and that subjects were adequately informed of protocol amendments affecting their participation.
For Phase II-IV trials, drug accountability is a major focus for regulatory bodies. We audit the site's pharmacy or storage facilities to check temperature logs, storage conditions, dispensing records, and the reconciliation of used and unused IP. We ensure that the chain of custody is unbroken and clearly documented.
In late-phase trials, the volume of safety data increases significantly. We verify that all Adverse Events (AEs) and Serious Adverse Events (SAEs) have been identified, documented, and reported to the sponsor and regulatory authorities within the required timelines. We look for "hidden" AEs in medical records that may not have been captured in the CRF.
Targeted audits triggered by specific concerns such as repeated protocol deviations, data inconsistencies, elevated query rates, or safety reporting issues. These audits focus narrowly on the area of concern and provide sponsors with actionable findings to address root causes.
Designed to simulate a regulatory inspection (e.g., FDA BIMO, EMA, or MHRA) at the investigator site. These audits assess whether essential documents, source data, drug accountability records, and staff training files would withstand scrutiny during an actual regulatory inspection.
Detailed comparison of data entered in case report forms (CRFs) against source documents (medical records, laboratory reports, imaging data). This audit confirms that reported data are attributable, legible, contemporaneous, original, and accurate, consistent with ALCOA+ principles.
Conducted at or near the end of a site's participation in a trial. These audits verify that all required documentation is complete, regulatory files are properly archived, and final reports to IRBs/ECs and regulatory authorities have been submitted in accordance with ICH GCP and local requirements.
In the modern era of clinical development, the complexity of trial protocols and the volume of generated data have grown exponentially. Independent third-party audits serve as a crucial quality assurance mechanism, distinct from routine site monitoring.
Patient Safety
The foremost priority of any clinical trial is the rights, safety, and well-being of the trial subjects. Our audits rigorously review the Informed Consent process, adverse event reporting, and protocol adherence to ensure subject protection is never compromised.
Data Integrity
Regulatory submissions rely on accurate, credible data. We apply the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available) to verify that source data matches the data entered into the Case Report Forms (CRFs).
Regulatory Readiness
Regulatory authorities such as the FDA, EMA, and PMDA conduct their own site inspections. A proactive third-party audit by Protheragen simulates an agency inspection, allowing sponsors to identify and rectify non-compliance issues before regulatory submission.
Contact us to learn more about Protheragen's phase II-IV clinical trial site audit services. We will work with you to design an audit plan that fits your program's timeline, risk profile, and regulatory requirements.
1. How does a third-party site audit differ from routine monitoring visits?
Routine monitoring visits are conducted by clinical research associates (CRAs) as part of ongoing trial operations and focus on source data verification, query resolution, and site support. A third-party audit, by contrast, is an independent, systematic evaluation performed by qualified auditors who are not involved in the day-to-day conduct of the trial. Audits assess the overall quality system at the site, verify compliance with GCP and regulatory requirements, and evaluate whether monitoring and oversight activities are functioning as intended.
2. What happens if critical findings are identified during the audit?
If a critical finding is identified—such as an issue posing immediate risk to patient safety or a severe breach of data integrity—our auditor will communicate this to the sponsor immediately, rather than waiting for the final report. The site will be required to develop an urgent Corrective and Preventive Action (CAPA) plan. Protheragen can assist the sponsor in reviewing the adequacy of the proposed CAPA to resolve the critical issue.
3. How does Protheragen maintain the confidentiality of patient data during the audit process?
Confidentiality is fundamentally integrated into our auditing methodology. Our auditors are bound by strict non-disclosure agreements and are trained to comply with international data protection regulations. During Source Data Verification (SDV), auditors review anonymized or coded records wherever possible. Final audit reports are securely delivered exclusively to designated sponsor representatives, ensuring that patient identities and proprietary study information remain fully protected.