EDCPRO: Clinical Trial Data Management Software  

Meeting the needs of Study Coordinators, CRAs & Projects Managers

EDCPRO is a powerful and effective Web-based clinical data management system that incorporates SCiAN's 15 years of EDC knowledge and experience in managing clinical trials. Founded on our therapeutic area expertise, the intuitive user interface helps Study Coordinators and Monitors complete their data management tasks with ease, efficiency and minimum administrative overhead.

EDCPRO guides Study Coordinators and Monitors towards consistent data collection and protocol interpretation.  In addition,  the system was designed with a comprehensive suite of data management tools to support the work of Medical Monitors, Database Managers (tools for coding, SAE reconciliation, preparation of database for DSMBs, interim and final analyses, etc).

Core functionality

  • FDA 21 CFR Part 11 compliant
  • On-line help system
  • User qualification module
  • User registration and access management
  • Randomization
  • Study drug / clinical supply management
  • Online data validation / edit checks
  • SDV and associated query management
  • ePRO - IWR interface
  • Auto email notification system
  • Document Management
  • Status reporting
  • On-demand reporting / data export: Excel database export
  • Data import using CDISC ODM compliant transfers from 3rd parties
  • Data export / archiving using CDISC ODM compliant XML format
  • PDF archiving.

Extended functionality for high impact trials

For comprehensive support of drug development phase clinical trials where the risk of delays and data inconsistencies have to be minimized, the systems includes additional safeguards and functionalities, such as:

  • Proprietary "Guided Data Entry"™ system;
  • Customizable workflow to incorporate the Sponsor's/CRO's business practices and SOPs;
  • Active case management;

and a comprehensive set of data management tools to support the work of Medical Monitors, Database Managers, Statisticians and Medical Writers; tools for:

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