Quality Assurance

Quality Assurance services comprise:

• Performing clinical audits to evaluate trial conduct and compliance of the trial to (1) protocol, (2) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guideline, (3) applicable requirements of the regulatory authority and Institutional Review Board/ Independent Ethic Committee (IRB/IEC) and (4) sponsor’s and SCRI’s standard operating procedures (SOPs)
• Conducting pre-audit/pre-inspection preparation for site personnel and clinical operations staff, and providing on-site support activities during audits and inspections
• Training of site and clinical operations staff to meet requirements of audits from the institution, sponsor or health authority inspections
• Providing GCP consultation and guidance to stakeholders
• Fulfilling of QA services for external clients i.e. conducting onsite audit and inspection preparation

The Quality Assurance department works closely with sponsors and local regulatory authorities for inspections and audits of clinical trials and their sites, ensuring that clinical studies are conducted with compliance to approved protocols, guidelines and regulations. With the ability to provide quality management services for clients, including conduct of on-site GCP audits, the department builds quality into clinical trials by establishing internal SOP processes, while keeping project stakeholders abreast of evolving regulatory requirements. For the purpose of human subject protection and study data quality, the department highlights the importance of research compliance and builds awareness of auditing requirements and procedures. Safeguarding the effectiveness and relevance of quality management activities is key. The Quality Assurance team keeps up with the evolving regulatory climate for clinical trials involving drugs and medical devices to ensure that its processes and procedures adapt to changing guidelines. Quality Assurance is fundamental to establishing the merits in the delivery of SCRI’s core services, ensuring protection of human study subjects and reliable data returns. Building quality by design can help ensure that all aspects of the trial are operationally feasible with reduced complexity, thereby improving the efficiency and quality of the trial. With the introduction of the new integrated addendum to ICH E6(R1) of the GCP Guideline, there is increased focus on quality management systems using a risk-based approach. The Quality Assurance team is exploring the potential of a quality management system that can be applied throughout all stages of the trial process so as to enhance efficiency and operational feasibility of investigator-initiated trials.