This Quality Assurance Unit was set up in February 2008 with the main objective to ensure that all CRC’s projects and support activities are conducted efficiently and in accordance with applicable international quality standards, professional guidelines and regulatory guidelines. The unit has to also ensure compliance with clinical research ethics and governance.

CRC has established, documented, implemented, and main¬tained a quality management system and continually improved its effec¬tiveness in accordance with the requirements of applicable international quality standards.

The organization has identified the processes needed for the quality management system and its application throughout the organization, and has determined the sequence and interaction of these processes as well as criteria and methods needed to ensure that both the operation and control of these processes are effective.
 

Role of the QA Unit are to:

1. Plan and direct the Quality Assurance Unit in accordance with the stipulated requirements of CRC quality system.
2. Ensure that in any interactions with CRC’s external stakeholders and clients, the conditions, procedures or decisions are safe, dignified, not unnecessarily intrusive, and provide appropriate confidentiality and privacy.
3. Interact with all units to remove bottlenecks impacting research quality enforcement, including the resolution of non-conformance.
4. Coordinate all inspection and auditing work in line with cost control, scheduling and operations requirements.
5. Develop and maintain processes necessary to achieve the principles of quality, scientific and ethical integrity, trial subjects’ safety and excellence in clinical research.
6. Implement auditing activities that ensures all projects undertaken by CRC are carried through in accordance with ISO 9000, the local and international laws, Good Clinical Practice (GCP) & applicable Standard Operating Procedures (SOPs).
7. Ensure that SOPs are updated and maintained.