Maintain regulatory compliance and inspection readiness with our comprehensive auditing services.
Ensure the integrity and compliance of your clinical trials with a range of tailor-made auditing services. Our specialist auditing partners conduct internal, vendor, and site audits to help you de-risk your clinical operations and ensure inspection readiness throughout all stages of clinical development.
Our approach to auditing involves a systematic examination of your clinical trial processes, systems, and preferred vendors. Leveraging advanced risk-based methodologies, we offer pre-emptive risk identification and mitigation strategies, ensuring your clinical operations will continue to run smoothly and remain resilient in the face of unexpected challenges.
Triall has built a network of selected CRO partners who each excel in their respective domain, allowing us to offer you a truly end-to-end service offering. Each partner has undergone a rigorous vendor qualification to ensure our services meet the highest standards.
We perform audits at every stage of the clinical trial. From quality management systems to trial master files, to electronic trial data handling and reporting, our audits scrutinise and fine-tune all of your internal systems. Our thorough review processes ensure data integrity, GCP compliance, and effective implementation of risk mitigation strategies, providing you with actionable feedback and full visibility.
We understand the critical role of external partners in clinical trial operations. Our vendor auditing services evaluate the performance, reliability, and regulatory compliance of your preferred vendors, including central laboratories, technology providers, and other external partners. We will dive into their SOPs, quality controls, data integrity checks, and the calibration of involved instruments.
Our site audits assess clinical trial sites for effective investigator involvement, accurate data collection, protocol adherence, and patient safety. We perform these audits through repeated site visits and discussions with site staff members. Our analysis provides an overview of the site's readiness to deliver timely, high-quality data, and to meet applicable regulations and quality standards.
Regulatory inspections can be a daunting process. We help you prepare by conducting mock inspections, performing gap assessments, and offering training programs tailored to your team's requirements. This helps ensure inspection readiness, builds confidence within your team, and reduces potential inspection risks, thus reinforcing your path to delivering successful and regulatory-compliant clinical trials.
We work in close collaboration with your team to thoroughly understand the scope, objectives, and key areas of concern. This allows us to create a custom-tailored auditing plan that aligns with your organisational needs.
Whether it's an on-site visit or a remote assessment, our auditors can conduct thorough evaluations of processes, documentation, and systems from any location and geography.
We provide you with a comprehensive audit report that outlines audit findings,key observations, and actionable recommendations. We're committed to clear and transparent communication.
After communicating audit findings we work alongside your team to implement corrective and preventive actions, fostering an environment of continuous improvement.