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Services

Cardinal Systems' portfolio of services range from conception and realisation of the different aspects of a clinical trial through to exploitation of the results and their presentation for submission to the appropriate regulatory authorities and/or publication.

In particular, we provide the following services:

  • Advice on methodology or statistical analysis (study design, statistical analysis plan, review of the investigator’s brochure, regulatory issues)
  • Project management (complete management of the project including contract specifications, hiring/management of external specialists and monitoring/reporting)
  • Monitoring (including the management of specialist technologies and resources)
  • Randomisation and logistics centralised by a vocal server (IVRS)
  • Installation and maintenance of Internet applications (e.g. InfoGate, a company innovated electronic workflow solution for eMonitoring, EDC and eCTD)
  • CRF design and data management (data entry, validation)
  • Statistical analysis
  • Preparation of ICH E3 study reports, their annexes and eCTD

Our services also include conception and realisation of surveys (classic or by Internet).

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Partners & Working Groups

Cardinal Systems works in partnership with O4CP for the Loulla & Philla FP7 project.

Loulla Philla

 

Cardinal Systems has been supporting France Biotech since 2001, and works closely with governmental institutions implicated in the valorisation of innovation, such as Oseo, Comite Richelieu (Pactepme) and Medicen.

France Biotech

Partners

 

Cardinal Systems participates actively in working groups, such as DIA, PSI and CDISC.

Working Groups