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 |  |
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| Validates CDISC and custom data formats | |
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| Detailed reporting in Excel, CSV, and HTML | |
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| Issue management across entire study lifecycle | |
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| Secure hub for data exchange with partners | |
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| Enterprise dashboard and reporting | |
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| MedDRA validation | Manual | Automatic |
| Deployment Options | ||
| Desktop Client | |
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| Hosted Web Application | |
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| Central configuration and management | |
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| Automated software updates | |
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| Increased scalability | |
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| Quality and Regulatory Compliance | ||
| Benefits from testing by worldwide community | |
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| Rigorous QA, performance, and scalability testing | |
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| GxP and 21 CFR Part 11 compliant | |
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| Support | ||
| Community support forum | |
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| Professional email and telephone support | |
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| Service level agreement | |
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| Professional Services | ||
| Custom rules, reports, and metrics development | |
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| CDISC and regulatory consultancy | |
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| System integration | |
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| Training | |
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