EDC SOLUTION

EDCPRO: Clinical Trial Data Management Software

EDC that guides study coordinators and monitors toward consistent data collection and protocol interpretation. The system also offers a complete suite of data management tools to support medical monitors and database managers that includes SAE reconciliation, preparing the database for DSMBs, interim and final analysis and much more:

 

  • Inventory management
  • Site payment
  • Online help
  • Randomization IVRS/IWRS
  • ePRO
  • Document management
  • PDF archiving
  • Data import using CDISK ODM compliant XML format
  • Ad hoc reporting and status review
  • WHODrug dictionary-supported medication entry
  • Medical coding
  • Multi-level custom validation
  • Protocol deviations and violations check
  • Multi-language
  • SDV query management
  • FDA 21 CFR part 11 compliance

In addition, EDCPro has a complete set of data management tools to support the work of Medical Monitors, Database Managers, Statisticians and Medical Writers, including:

 

  • On-demand PDF/Excel case histories
  • On-demands plots and graphs
  • Coding medical history, adverse events, medications
  • Reconciling SAE between the clinical and safety databases
  • Preparation of database for the DSMBs
  • Preparation of the database for formal interim and final analyses

 

Find out how EDCPro can meet your unique study needs by contacting one of our experienced professionals.

"EDCPro's workflow process delivers consistent and timely results through a flexible and intuitive database platform."

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