Quality Management System (QMS)
The Quality Management System (QMS) describes the organizational structure, processes, and resources needed to provide high-quality services, achieve quality objectives, and satisfy customer needs. The implementation of a comprehensive QMS impacts all parties involved in a research program, including:
by accelerating identification and resolution of clinical study issues.
by minimizing study delays and decreasing time to market.
by improving compliance with SOPs, GCP, and external regulatory policies.
Do you want to find out how our QMS procedures can improve the quality of your clinical study?
ethica CRO employs a range of quality management processes, determined based on the specific features and requirements of your study, such as trial design, sample size, potential risks, and primary endpoints. The fundamental procedures outlined in our QMS include:
Quality Manual (SOPs)
Organizational Structure and Responsibilities
Data Management and Document Control
Our Quality Objectives and SOPs
ethica CRO’s quality objectives help us define, strategize, and prioritize expectations about our research goals. These objectives encompass our Human Research Protection Program (HRPP), customer experience and satisfaction, compliance requirements, and our internal standard operating procedures (SOPs).
Our quality manual and SOPs direct ethica CRO in achieving its quality objectives and proceeding in the case of non-conformities, without compromising the well-being of research participants. Further maintenance-related activities pertaining to our SOPs include:
Our SOPs are updated regularly in accordance with CAPA and internal auditing activities.
Our SOPs are reviewed annually to maintain consistency with evolving quality, regulatory, and study requirements.
Our QMS Organizational Structure, Auditing and Data Management
ethica CRO’s QMS oversees the organizational structure and responsibilities of research parties to best support our study and quality objectives. By tracking and renewing employee training and certification, the QMS also ensures that our employees always possess the skills necessary to undertake their professional activities.
Our QMS oversees internal, study, and vendor auditing activities to track the degree of achievement of ethica CRO’s quality objectives, regulatory compliance, and SOP adherence. Our auditing procedures involve continuous improvement activities, including corrective and preventive action (CAPA), and are conducted at various timepoints throughout the study lifecycle. CAPA aims to ameliorate our study management performance and rectify non-conformities such as protocol deviations and adverse events by implementing a corrective or preventive action plan.
Before a vendor can be selected for a study, a vendor audit must be conducted to verify that its QMS, SOPs, and other relevant policies are in line with ethica CRO’s standards and quality objectives. In the case that the vendor is a software provider, it must also undergo a system validation process before it can be selected for a study.
As per our SOPs and data security procedures, all data and documents pertaining to quality assurance monitoring and auditing activities are securely stored and strictly controlled at all times.