Our quality professionals closely examine your particular study before planning and executing study-specific GCP audits. We focus on key areas including protocols, investigator sites, trial master files, pharmacovigilance, databases, and reports. With the help of our experienced industry professionals, you can be confident knowing results are credible and accurate while maintaining quality practices throughout the research.
Our GCP auditing services include, but are not limited to:
Clinical trial audits are tailored to your particular compliance needs and stage of product development. Our Quality Assurance team has performed audits in a variety of markets both domestic and international.
Our Mock Bioresearch Monitoring Program (BIMO) inspections are designed to prepare your organization for potential FDA inspections thoroughly. These simulated inspections provide a realistic experience of an actual FDA BIMO inspection, helping you identify and address potential compliance issues before they become problematic during a real inspection.
Our experienced auditors, many of whom are former FDA, conduct these mock inspections with the same rigor and attention to detail as an actual FDA inspection. This service is invaluable for organizations looking to ensure they are fully prepared for regulatory scrutiny.
Key features of our Mock BIMO Inspections:
Our comprehensive auditing and document review services cover critical aspects of your clinical research documentation. We focus on three key areas:
We review your SOPs to ensure they are:
Our protocol reviews assess:
We evaluate various types of clinical study reports, including:
Our review ensures these reports are accurate, complete, and comply with regulatory requirements and GCP standards.
Our site audits help identify areas for improvement, ensure data integrity, and maintain compliance with GCP standards throughout the clinical trial process. Our experienced auditors perform detailed audits of clinical sites to assess compliance with GCP standards and study protocols.
These audits cover all aspects of clinical trial conduct at the site level, including, but not limited to:
Our TMF audits help ensure that your trial documentation is inspection-ready and compliant with GCP standards and regulatory requirements.
Our TMF audits cover:
Our team conducts comprehensive audits of Contract Research Organizations (CROs) and other vendors involved in clinical trials to ensure they meet GCP standards and contractual obligations.
These audits typically include, but are not limited to:
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.