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Quality

Our vision of Quality

Quality is at the heart of our organizational system :

  • ISO 9001 Certification since 1998 provides a framework for good organizational and management practices
  • ISO 27001 Certification since 2008 guarantees the management of information security (ISMS), the hosting of our data and our applications
  • Compliance with Reference Methodologies (MR001 and MR003)
  • Data Protection Officer (DPO) ensures the confidentiality of personal data
  • Research Tax Credit approval since 1991

 

Logo Bureau Veritas - ISO 9001
Logo Bureau Veritas - ISO 27001

5 strategic axes allow Quality to respond to the growing complexity of clinical research :

  • Technicality in all our “business” processes (GCP, clinical data management BP (SCDM) review of deviations and CAPA, evaluation of performance indicators, QA plan, training, etc.)
  • Understanding the regulatory, economic and strategic issues of a clinical study
  • Identification of risks and their management (risk management plan and mitigation actions)
  • Regulatory watch and its interpretation (regulation 536/2014 relating to clinical trials, regulation (EU) 2017/745 relating to medical devices, RGPD n ° 679/2016, …)
  • Internal audits and compliance with normative requirements (ISO 9001, 27001, 14155, 13485, 21 CFR part 11, Gamp5, …)

 

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