OpenCDISC Community Tools

OpenCDISC Community is a collaborative project to develop open source, easy to use, and commercial-quality tools. Today, the suite of open-source tools includes the game-changing Validator — along with Define.xml Generator, a Data Converter, and more — to make compliance easily manageable for the entire biopharmaceutical industry.

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
Data Validation Features Community Enterprise
Validate SDTM, SEND, ADaM, and Define.xml Yes Yes
Metadata driven and configurable Yes Yes
Data composition and quality reports   Yes
FDA Data Fitness assessment scorecards   Yes
Manage issues throughout the study lifecycle   Yes
Communicate and collaborate with partners   Yes
Monitor data quality improvement over time   Yes
Track changes across validations   Yes
Customize specs for SDTM+ or sponsor formats   Yes
Design rules for projects, studies, and partners   Yes
Define.xml Features    
Create Define.xml 2.0 for SDTM, SEND and ADaM Yes Yes
Convert Define.xml 1.0 files into Define.xml 2.0 Yes Yes
Extract metadata from SAS datasets Yes Yes
Extract origin page numbers from annotated CRFs   Yes
Merge metadata from external specifications   Yes
Generate Define.pdf   Yes
Validate Define.xml content in real-time   Yes
Compare content with standards and other studies   Yes
Track changes between versions   Yes
Other Features    
Deployment Options Desktop Web Hosted
Automated software and rule updates Yes Yes
Central configuration and management   Yes
Sandbox environment for training and testing   Yes
Increased scalability   Yes
Software license Open Source Subscription
Quality, Compliance, and Support    
Community support forum Yes Yes
Professional email and telephone support   Yes
Rigorous QA, performance, and scalability testing   Yes
GxP and 21 CFR Part 11 compliant   Yes
Service level agreement   Yes