Clinical Trial Data Center for IND Stage Trials

Pulls the study team together for consistent and credible results

Based on the EDCPRO platform, SCiAN's Custom Software Development team delivers integrated e-clinical solutions matching your needs and streamlining key trial management activities across many tasks, departments and expertise in your clinical trials: 

  • Full EDC functionality
  • Randomization - all randomization algorithms and blinding methods supported
  • Study drug and clinical supply management (IWRS)
  • SAE management with SAEPRO or integration with your internal system 
  • Coding - SAE reconciliation modules
  • Central data monitoring tools
  • Document management
  • Central lab, ECG, Imaging data integation with your internal and 3rd-party systems
  • DSMBs, Interim and final analyses management module
  • CTMS modules:
    • Regulatory documents management
    • Protocol Amendments - EC/IRB approval tracking
    • Contacts management
    • Resource allocation optimization
    • Dashboard of key performance indicators: key trends, comparisons, and exceptions
    • Site payments module.

 Core functionality

  • FDA 21 CFR Part 11 compliant
  • Intuitive user interface - guided data input & on-line help system
  • User qualification module
  • User registration and access management
  • email notification system
  • Comprehensive document management module
  • On-demand reporting / data export
  • Data import using CDISC ODM compliant transfers from 3rd parties
  • Data export / archiving using CDISC ODM compliant XML format
  • PDF archiving.