Quality management systems will full fill two important requirements in this context:
- The customers’ requirements – confidence in the ability of the organization to deliver the desired product and service by consistently meeting customer’s needs and expectations.
- The organization’s requirements – both internally and externally, and at an optimum cost with efficient use of available resources (equipment, personnel, technology and information, etc).
Regarding Institut du Cerveau – ICM activities, the goal of our quality system is to demonstrate its compliance with international quality standards and regulatory rules to increase customer’s satisfaction.
Several quality strategies are developed according to the scientific activities and regulatory rules:
For our technological services
We chose the ISO9001:2008 standard as quality management system. Institut du Cerveau – ICM would like to increase customer’s satisfaction and insure scientific quality of the service. It now concerns for example vectorology, genotyping, histology, and CENIR core facilities and it will be extend to all of them in the future. Our customers are industrial, academic, startups, and Institut du Cerveau – ICM scientific partners.
For pre-clinical trials
The GLP (Good Laboratory Practice) guidelines from OCDE are quality management standard references. It concerns scientific projects like GlioTex which proposes new medical ways for pre-clinical pharmaceutical trials. It will guaranty quality and traceability of scientific results and will satisfy regulatory medical instances (FDA, ANSM) for future clinical trials.
For clinical trials
The GCP (Good Clinical Practice) guidelines from OCDE are applied in institutions dedicated to clinical trials. In the CIC institution, compliance is evaluated every four years by a scientific advisory board (composed by INSERM and AP-HP instances). GCP guidelines are also applied in the quality system management of all Institut du Cerveau – ICM core facilities included in clinical trials, such as CENIR.
CONTRACT RESEARCH SERVICES DELIVERED BY THE VECTOROLOGY PLATFORM AND GENOTYPING-SEQUENCING PLATFORM.