ASCOPHARM Conctact ASCOPHARM
 
eCRF

Together with ARONE, ASCOPHARM and the NOVASCO Group have developed a powerful engine (Projection™) in order to produce web-based applications.

The system permits to develop a complete tool which may associate one or more of the following segments:

  • Electronic Case Record Form which is the hart of the system. eCRF include formularies which may remain very similar in aspect and utilisation than paper documents. An intuitive presentation in arborescence provides easy utilisation to non-expert web users. Graphic aspect may be customized to include client specifications and logo.
  • High security, traceability, and documented system with complete audit trail and Oracle engine. The system is compliant with 21CRF part11 recommendations and includes systematically a profile / user management tool.
  • E-training module which may integrate pre-study evaluation of investigators, training to the study, quiz evaluation, final certification of investigators and centres, documentation and electronic signature.
  • Web-based randomisation system whenever needed,
  • Study specific tools such as ADRs or SUSAR notification or reporting into a specific formulary,
  • Informative module which may integrate all cross-information from the central data base and eCRF (such as study status, inclusions, tables, listings, on-line newsletter, etc)
  • Other customisable modules such as start-up regulatory check lists, document data base, etc..
  • Complete interface with electronic tools (e-mail, ftp access, fax, etc..) for multiple automatic alerts and documentation.
  • A query management module for automatic semi-automatic and manual query generation, listing and resolution.
 In addition the system may integrate back-office functions of our Data Management tools and may permit simple or dual independent data entry whenever needed.


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