Quality assurance (QA) ensures every study we support meets the highest regulatory, ethical, and scientific standards. Through proactive oversight, robust systems, and continuous improvement, we protect participants, maintain compliance, and ensure the credibility of trial data. QA ensures clinical trials are conducted to the highest regulatory, ethical, and scientific standards. Our Quality Management System (QMS) is at the core, setting the framework for planning, documenting, and continuously improving processes. QA covers developing and maintaining Standard Operating Procedures (SOPs), audits, staff training, and monitoring quality metrics. It focuses on prevention rather than correction to safeguard participants and ensure credible trial data.To achieve this, we apply a range of QA processes, including risk assessment, vendor assessment, and computer system validation (CSV), to ensure robust oversight and high-quality trial delivery. Risk assessment Risk assessment helps identify and manage potential risks to participant safety, data integrity, regulatory compliance, and overall study quality. The process considers factors such as study design, the investigational product (e.g. drug or device), pharmacovigilance, trial population, research environment, and the experience of the study team.All CTIMPs (Clinical Trials of Investigational Medicinal Products) and CIMDs (Clinical Investigations of Medical Devices) undergo risk assessment, as do projects with complex designs, novel interventions, or vulnerable populations.When a project is identified for risk assessment, a meeting is scheduled with ACCORD representatives, investigators, and trial managers. Together, they review the study, assess potential risks (low, moderate, or high), and agree on mitigation strategies. In some cases, trial methods may also be adapted to make the research more efficient while maintaining regulatory and ethical standards.After the meeting, ACCORD provides written feedback and finalises a signed document outlining risks and agreed mitigations. This assessment supports monitoring decisions and authorises submission to regulatory bodies, ensuring proportionate safeguards are in place for both participants and the credibility of the research.[add examples of common risk assessment findings] Vendor assessment Vendor assessment ensures external partners, such as Clinical Trials Units, laboratories, and e-system providers, meet required regulatory, ethical and scientific standards. Depending on study design and risk, this may involve reviewing vendors’ QMS and SOPs, evaluating past performance, or conducting audits. Careful vendor oversight helps maintain compliance, safeguard participants, and protect data integrity. Computer system validation Computer System Validation (CSV) confirms that electronic systems used in trials, such as data capture platforms, safety reporting tools, and laboratory information systems, are reliable, secure, and compliant. The process involves planning, testing, documenting, and verifying that systems perform consistently and protect data integrity. Validating systems in this way supports compliance with Good Clinical Practice (GCP), maintains data accuracy, and safeguards participant confidentiality. Contact the QA team This article was published on 2025-09-22
