ISO 9000 defines quality as a set of characteristics that a product or service must have to satisfy needs and expectations of the customer. While Quality Management System is a tool to establish and continuously achieve quality objectives based on customer’s requirements. In clinical research we have the following objectives: compliance with ethical, regulatory and GxP standards and reliability of clinical data.
Clinical research quality is designed in advance of enrolment of the first patient. Appropriate planning of a trial, adequate monitoring and verification ensure quality of the clinical study.
Clinmark is committed to delivering quality, regulatory compliant clinical research services in a professional, efficient and cost-effective manner, at the same time protecting patient safety and data integrity. Our quality management and assurance approach means a lot of possible risks may be prevented. To ensure that quality matters in every aspect of the process, our tools, such as SOPs, working instructions, training, audits, adequate recording and reporting of the data are considered to be at the core of Clinmark’s QA/QM processes across the world.
Contact us to build high-quality standards in your clinical development.