Quality Assurance

Our quality assurance service ensures meticulous oversight and compliance throughout every phase of your clinical study, safeguarding data integrity and regulatory adherence.

OUR DEDICATION

Quality Assurance

Quality Assurance assesses the quality of the study data, study documentation, and study conduct. It identifies and resolves any quality issues and ensures that appropriate corrective and preventive actions are implemented. Quality Assurance is fundamental to the success of a clinical study.

Our services include; Protocol Audit, In-Phase Audit/Data Audit, Clinical Study File Audit, Final Study Report Audit and Third Party Vendor Audit.

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Protocol Audit

Protocol Audit involves reviewing the protocol to identify any inconsistencies, ambiguities, or areas that may lead to confusion or non-compliance during the study. The audit also checks for compliance to VICH GCP guidelines and applicable regulatory requirements. A review of Sponsor Standard Operating Procedures (SOPs) and templates can also be performed.

In-Phase Audit/Data Audit

In-Phase Audit/Data Audit conducted at the investigator sites during the study. The primary goal is to verify that the study is being conducted in accordance with the protocol, SOPs and VICH GCP guidelines. The auditor reviews source documents, checks data accuracy, and ensures that the study is being performed consistently across all sites. This audit is performed prior to data base lock and before Investigator sites are closed to ensure data integrity prior to the process of blind case deviation review and statistical analysis.

Clinical Study File Audit

Clinical Study File Audit conducted towards the end of the study to ensure files are complete, accurate, and consistent with other documentation. The auditor reviews the clinical study files to verify that all required documents are present, completed as applicable, and signed and dated appropriately.

Final Study Report Audit

Final Study Report Audit, including cross checking a percentage of the report data tables against the data listing, review of statistical reports and of the final study report to ensure it accurately represents the data and reflects the study objectives, is complete and complies with VICH GCP guidelines and applicable regulatory requirements.

Third Party Vendor Audit

Third Party Vendor Audit conducted to ensure that vendors involved in the study, such as contract research organisations (CROs) and analytical laboratories, are qualified to the standards required (e.g. GLP), and procedures conducted are compliant with the study protocol, SOPs, and applicable guidelines. The auditor reviews the vendor's qualification documents, monitors their performance during the study, and if required by our client, conducts periodic on-site audits to ensure continued compliance.

Example of quality

Unlock the Full Potential of Quality Assurance

Whilst some clients prefer The VICH GCP Consultancy to operate according to the Sponsor’s own SOPs, checklists are typically developed for each project. These checklists are tailored specifically to the study, and would likely include a data check against the study schedule of events and identify the QA points for audit based on the study phase and data set.

Don't miss out on experiencing the full scope of our commitment to excellence. Click below to download an example of our QA checklist and witness firsthand how we ensure the highest standards are met.