Quality Management System
Modernization, globalization, increasing complexity of the projects and improving the methods of information gathering and analysis, as well as expanding the network of cooperation have forced us to raise the level of quality standards to a new level. We cannot create something extra in quality control system, but we can prove our excellence in this sphere.
We implemented the FDA's recommended four-step system approach:
- Say what you do (a qualified and responsible management team to provide governance of the whole clinical trial process; a robust oversight of the outsourced trial and excellent coordination among the project team members, to ensure good decisions)
- Do what you say (education and training)
- Prove it (risk-based monitoring and trend analysis)
- Improve it (effective corrective and reventive action)
Our quality systems include:
- personnel roles and responsibilities,
- training, policies and procedures,
- quality assurance and auditing,
- document management,
- record retention,
- reporting and corrective and preventive action (CAPA).
We provided FDA approved new inspection approaches such as risk-based inspections, surveillance inspections, real-time oversight, and audit of sponsor quality systems.
Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Under the GCP guidelines, the quality is a continuum, which begins with design, stays critical during conducting and recording, and continues during the reporting of trials.
We are using National Cancer Institute's standards for providing Quality Assurance/Quality Control.The following are key issues for QA/QC implementation and auditing:
- Staff proficiency
- Facility infrastructure (equipment validation and change control, calibration, maintenance, repair procedures, and environmental monitoring; e.g., temperature monitoring of freezers; supplier management program, including inspection and validation of reagents and other supplies.
- Biospecimen control and documentation (control of biospecimen collection, processing, and tracking; documentation of biospecimen collection, processing, and tracking; measurement and analysis of key process indicators to provide quality improvement; system security).
- Recordkeeping and document control (employment of a data quality management, assessment, and reporting system; clinical data records; accessibility of policies and procedures; documentation records, including audit reports, deviation reports, and corrective action/preventive action reports; external document monitoring to ensure that the facility remains up to date with relevant laws, standards, and best practice publications; staff training records, including record of staff adherence to training schedules; data quality management (source documentation and electronic records), assessment of reporting system; supply records).
- Internal audit of program and its policies, scheduled and unscheduled (audit of SOPs for all activities and processes: each biospecimen resource ensures that SOPs are written, reviewed, and appropriately approved, process exists for review and updating at designated time intervals).
- 45+ Standard Operating Procedures (SOPs) (all procedures and responsibilities of all key clinical trial processes, from protocol to preparation of the clinical study report, focus on the potential anticipated risks)
- Education and training of all CRO staff and site staff uniformly about the trial protocol, study requirements, policies and procedures
- Good Manufacturing Practice (certificate GMP)
- Good Laboratory Practices (certificate GLP)
- Data management system
- Certified Clinical Research Associates (CCRAs)
- Full-time quality assurance team, responsible for the monitoring and oversight of all clinical operations.
As the quality of clinical trials depends on esuring protection of human subjects, we always review the functioning of IRB and the most common deficiencies (meeting frequency, following the procedures, the presence of a majority of members during meeting, conducting a continuing review, maintaning IRB member rosters, risk determinations).