GCP Site Audits & Inspection Readiness Services

Long gone are the days where teams frantically scramble to prepare for an impending regulatory agency inspection or a Sponsor audit. Creating countless notes to file to correct errors and justify deviations or even pleading for additional copies of essential documents at the eleventh hour are simply no longer the norm.

Silvertree BioLife’s GCP Audits are designed to evaluate the compliance of clinical trial sites with the study protocol, ICH guidelines for Good Clinical Practice, applicable regulatory requirements and standard operating procedures. Our audits emphasize regulatory alignment and data accuracy, equipping sites to meet the highest standards, minimize risks, and ensure trial integrity. Key components of our Site Audits include :

• Pre-Audit Consultation: Tailored consultations to understand site-specific needs, scope of the study, and regulatory obligations, setting the foundation for an audit that precisely addresses critical compliance areas.
• Pre-Study Qualification Audits:  Evaluate investigational sites, vendors, or laboratories for GCP readiness before your trial begins.  Identify potential risks early and  ensure facilities, staff, and processes meet regulatory expectations. 
• Trial Master File Review:  Comprehensive review of the Trial Master File to verify that all essential documents are complete, accurate, and reflect current site status.
• Comprehensive Site Audits:  Thorough on-site or remote audits to meet with the Principal Investigator (PI) and site personnel, inspect site facilities, review trial documentation and site procedures, assess alignment with GCP standards and evaluate overall compliance.
• Ongoing Vendor Audits:  Evaluate vendor (CROs, laboratories, and third-party service providers) performance to assess GCP adherence, processes, and reliability as well as strengthen vendor oversight and performance.
• Corrective and Preventive Actions (CAPA): Identification of compliance gaps with a collaborative development of CAPA plans, addressing root causes to prevent future issues and promoting continuous site improvement.
• Audit Reports and Feedback:  Delivery of clear, actionable audit reports that outline findings, detailed feedback, and recommended steps to reinforce compliance practices.

Schedule a GCP Audit Consultation by emailing us at contact@silvertreebiolife.com.

A CAPA plan is a systematic approach used in clinical trials and other regulated industries to address issues or non-compliances identified during audits, inspections, or quality checks. The CAPA process aims to investigate root causes of issues, implement corrective measures to resolve them, and establish preventive actions to avoid recurrence. CAPA plans help maintain quality standards and regulatory compliance, ensuring that issues are effectively managed and do not compromise trial integrity, participant safety, or data quality.

1. Problem Identification: Define the issue or non-compliance identified, typically arising from an audit, inspection, or internal quality check.
2. Root Cause Analysis: Investigate and determine the underlying cause of the issue to prevent future occurrences.
3. Corrective Action: Outline specific steps to correct the issue, addressing the immediate problem to ensure compliance.
4. Preventive Action: Establish measures to prevent the issue from recurring, often through updates to procedures, training, or monitoring.
5. Implementation and Monitoring: Assign responsibility, set timelines for action items, and monitor progress to ensure the CAPA plan is effectively executed.
6. Documentation and Review: Document the CAPA process, including all actions taken, and review for completeness and efficacy.

Inspection readiness should be built into all processes during the clinical development of a product. With good planning upfront at the beginning of the program, many of the issues found during an inspection can be either prevented or their impact lessened.

Inspection readiness strategic planning can be incorporated in the following areas: 

• Standard Operating Procedures
• CRO and Vendor selection, management and oversight
• Investigator selection and management
• Clinical site management
• Monitoring procedures and activities
• Evaluation and reporting of adverse events and serious adverse events
• IMP accountability and documentation
• Trial Master File oversight
• Regulatory documentation

Maintaining a complete, organized, and compliant Trial Master File (TMF) is essential for the success of any clinical trial. TMF auditing services are designed to ensure that the TMF meets regulatory requirements, adheres to Good Clinical Practice (GCP) standards, and is inspection-ready throughout the trial lifecycle. 

Key Features of TMF Auditing Services: 

• Document Completeness and Accuracy: Comprehensive review to confirm all essential documents are present, accurate, and properly filed.
• Regulatory Compliance: Verification of adherence to ICH GCP guidelines and applicable regulatory standards, such as those set by FDA and EMA, to mitigate compliance risks.
• Inspection Readiness: Assessment of TMF structure and organization to ensure it is accessible and ready for regulatory inspections.
• Version Control and Metadata Review: Ensures all documents have correct version histories and accurate metadata, supporting clarity and traceability.
• Timely Filing: Evaluation of document filing timelines to confirm alignment with the trial's progress and regulatory expectations.
• Risk Identification and CAPA Recommendations: Identification of gaps, risks, or inconsistencies with actionable solutions through corrective and preventive actions (CAPAs).

TMF auditing services provide sponsors and CROs with peace of mind by ensuring the Trial Master File accurately reflects trial conduct and compliance. Whether performed at the trial start-up, interim, or close-out phase, a thorough TMF audit strengthens regulatory adherence, data integrity, and inspection readiness.