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DBM

A wide range of experience and services

From datapool conception and implementation for ISE/ISS and safety updates to the production of ready for submission elements such as CRTs, CRFs, Patient Profiles in PDF or datasets (SAS-xport files). Over the years Cardinal Systems has accumulated a vast experience from phases I to IV respecting the quality demanded by pre-marketing development. One of our major preoccupations is the continuity of data throughout the dossier (i.e. coherence between results in individual reports and summaries or meta-analyses).

We provide the following services:

  • Datapool conception
  • Datapool implementation
  • Trial Database set-up
  • Database conversion
  • CRF design
  • Coding and validation
  • Double data-entry
  • Interactive screen controls for Remote Data Entry

 

 

  • Validation plan
  • Edit-checks programming
  • Query generation and follow-up
  • Automatic status reports
  • Data management manual
  • CRTs, CRFs Patient Profile
  • Audits
  • Archiving using FDA recommendations and CDISC

 

Appropiate use of new technologies

The founders of Cardinal Systems have, for some considerable time, exploited so called "new" technologies/languages such as IP protocol, SGML, object oriented languages, Internet, HTML/XML, web applications and JAVA. Consequently these technologies can be used appropriately in a secure environment.

An easily expandable system

Database management applications are installed on RISC/Unix cluster. The network, composed of this cluster and light Network Computers (NC), is easily expandable permitting us to manage an extensive workload.

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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