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Clinical Database Management

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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 programmation
  • Query generation and follow-up
  • Automatic status reports
  • Data management manual
  • CRTs, CRFs Patient Profile
  • Audits
  • Archiving using FDA recommandations 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.

Created by admin
Last modified 2007-04-20 19:29