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.