We have a unique CRO profile providing unique and innovative dual expertise combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry.
What We Do
International Conference on Harmonisation (ICH), a group consisting of the regulatory authorities of the European Union, Japan and the United States of America, produced a set of guidelines to ensure that:n 1990 the
Now, all Clinical Trials must adhering to Good Clinical Practice (GCP) and ICH E6. GCP is defined by EU Directive 2001/20/EC : “a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”
Within PopsiCube-Fovea, we consider that maintaining accuracy and quality throughout a clinical study is a continual, dynamic process.
PopsiCube-FOVEA obtained the ISO 9001 Certification of its Quality System on December 7th, 2000 (1994 edition), thus becoming one of the very first CROs certified in France. This certification was updated for the 2008 edition on June 11th 2009.
Our Quality Team acts internally to maintain our Quality System at a high level and acts also as Quality Services to help our clients ensure the integrity of their clinical trials. We advise clients on how to verify the integrity of scientific data and ensure adherence to protocols and international regulatory guidelines.
Our experienced auditors provide quality assurance audit services to our clients as part of a full-service or a stand-alone project. We provide expert Quality Assurance consulting services to pharmaceutical, biotechnology, medical device, and dietary supplement companies to help ensure they are in compliance with current business practices and regulations.
Among the clinical quality assurance services we provide are:
Among the computerized GxP system quality assurance services are: