SERVICES

Since their initial development in 1996 and after being used across the world as a set of guidelines, Good Clinical Practice (GCP) has become law as of 2004 for all investigational medicinal product clinical trials in the European Union. Before, in 1990 the 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:

• The data and results of clinical trials are credible and accurate.
• The rights, safety, well-being, and confidentiality of participants in clinical trials are respected and protected.

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:

• Clinical investigator site audits (routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews)
• Clinical database audits and study report reviews
• Clinical study document reviews
• System audits, in which we assess a client’s standard operating procedures (SOPs), processes and staff training programs and recommend improvements if/where needed
• Vendor audits, in which our auditors evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations

Among the computerized GxP system quality assurance services are:

• Computer System Validation services (writing SOPs, Risk Assessment, 21 CFR part 11 review …) and independent audits
• Auditing Software Vendors
• Preparing for a Software Quality Audit

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