Historical

/Historical
Historical Emmanuel Sanchez 2018-04-11T11:36:27+00:00

HISTORICAL

  • 2017 : Expands to studies with access to relevant administrative healthcare database.
  • 2016 : Expands to bioequivalence study
  • 2015 : Compliance of the Information Security Management Systems (ISMS) with ISO 27001.
  • 2014 : Consolidation of the Vigilance department and the extension of services – Celebrates 30th anniversary
  • 2013 : Expands to ATU* (Temporary Authorisations for Use)
  • 2011 : Expands to clinical study with liberal nurses as home Trial Support.
  • 2010 : Expands to PASS study (Post Authorization Safety Study)
  • 2007 : Internalisation of statistical activities
  • 2005 : Expands scope to include Epidemiology with a large range of research in this field in France and in Europe: Non-interventional studies, prospective and retrospective studies, registries, cohorts, studies requested by the authorities…
  • 2001 : Expands scope to include medical devices‘clinical investigations
  • 2000 : Expands to Europe: Lead management of international clinical trials performed in France and other countries in Europe and in the Maghreb countries (Morocco and Tunisia).
  • 1997 : Expands scope to include Data Management. We can lead data-management activities for Multicentric, international studies (in our experience: up to 14 countries for a study).
  • 1997 : 1st ISO 9001 Certification of its Quality Management System (QMS). Since then, the company has been enrolled in a continuous improvement process, maintains its certification (current version ISO 9001: 2015) and has a mature Quality Management System, compliant with the regulations of the profession in permanent evolutions.
  • 1992 : 5 employees – Expands scope to include Project management, sites’ selection and sites’ monitoring.
  • Création of ITEC Services which is one of the first CRO in France in the field of clinical research. Founded by Jacqueline Auzerie, Pharm. D.