OpenCDISC Validator

OpenCDISC Validator is a collaborative project to develop an open source, easy to use, and commercial-quality tool for ensuring clinical data compliance with CDISC standards, including SDTM, ADaM, SEND, Define.xml, and others. The Validator is metadata driven and configurable with checks defined using XML-based validation framework with power to support a wide range of rules and data formats including near-SDTM, SDTM+, and even custom datasets.

OpenCDISC is now available in two editions, Community and Enterprise. OpenCDISC Enterprise extends the benefits of open source Community edition to deliver a data quality solution for the full data life cycle. OpenCDISC Enterprise is backed by commercial support, regulatory assurance, training, and professional services for easy deployment throughout the enterprise.
See which version of OpenCDISC is right for your company
Software Features Community Enterprise
Software license Open Source (AGPL) Commercial
Metadata driven and configurable Yes Yes
Validates CDISC and custom data formats Yes Yes
Detailed reporting in Excel, CSV, and HTML Yes Yes
Issue management across entire study lifecycle   Yes
Secure hub for data exchange with partners   Yes
Enterprise dashboard and reporting   Yes
MedDRA validation Manual Automatic
Deployment Options    
Desktop Client Yes Yes
Hosted Web Application   Yes
Central configuration and management   Yes
Automated software updates   Yes
Increased scalability   Yes
Quality and Regulatory Compliance    
Benefits from testing by worldwide community Yes Yes
Rigorous QA, performance, and scalability testing   Yes
GxP and 21 CFR Part 11 compliant   Yes
Support    
Community support forum Yes Yes
Professional email and telephone support   Yes
Service level agreement   Yes
Professional Services    
Custom rules, reports, and metrics development   Yes
CDISC and regulatory consultancy   Yes
System integration   Yes
Training   Yes