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Managing global standards – or even study-specific specifications - presents many obstacles. Standards can be redundant or internally inconsistent. They can lag behind the hundreds of extensions or change requests submitted by your end users. They can get stuck siloed in a repository, unused by actual study teams, or they can be irrelevant for external vendor data.
Our solution for standards and specs clears the path to clean, consistent, organized data and unlocks the potential of your company's metadata portfolio. If you design or rely on standards/specs, you’ll see an exponential increase in your capabilities with our grid-like GUI editor, real-time validation, cloud collaboration, and suite of API integrations.
Build once, use a hundred times. With hierarchical metadata (parent-child-child...), each level refines the one above it, and commonalities get smartly inherited from model to implementation guide, to company-specific implementation—and all the way down to a specific clinical trial.
Add, edit, and maintain standards, terminologies, and CDISC specifications directly in your web browser. Reuse previously defined metadata, and assemble specs instantly from building blocks. In under a minute, you can combine a bit of SDTM IG 3.3 with your oncology-specific standards, or merge in schema from a similar study with instant feedback on conformance.
If you create specifications in spreadsheets and transmit them via email… stop doing that. It’s time to join us in the cloud and enjoy full flexibility and control over data requirements. Our web-based specification design system guarantees that sponsors and vendors are always working in the most up-to-date specs without ever leaving the platform.
Create specs by remixing and joining elements from your global data standards and other studies using our “shopping-cart” style builder. Dealing with a file from a novel niche vendor? Use the metadata in the file to get started. All changes are tracked for posterity, including discussion threads from our Spec Chat collaboration tool.
Before you even start programming, ensure your specification itself is compliant with CDISC and regulatory requirements. Familiar in-cell validation and color-codes help you stamp out errors. Convenient hyperlinks route you to the offending column or cell to keep quality in line with our expanded suite of metadata rules.
Generate spec-compliant, semi-random sample data—a huge time-saver for pre-programming checks, listings, and transformations, and for sharing examples with stakeholders during study startup.
Elevate standards and specs from artifacts into a centralized, living communications hub. The latest version of your spec becomes the sole location for discussing requirements and driving programming. Chat boxes stack in the cloud version of your specs, pointed to specific cells for context. API endpoints let stats programmers “call down” all or parts of the metadata to embed in their data transformations.
Roll your deployment strategy into your metadata, leveraging properties for Effective Date and status such as Draft, Provisional, and Final. Walk through unlimited archives to inspect granular changelogs, roll back or fork versions, and deploy or revert specific snapshots per your up-versioning strategy.
