Content catalog
Industry and client-specific standards in one searchable repository.
( Product )
Data Standards Governor
A centralized metadata repository for clinical standards, controlled terminologies and governed reference data.
Stop managing connected standards in spreadsheets.
Govern CRFs, data transfer agreements, SDTM, ADaM, controlled terminology and client-specific standards from one versioned platform.
( Problem )
Standards scattered across files and local repositories
Clinical and submission standards often live in Excel workbooks, Word documents, PDFs and team-specific folders. When a terminology changes, impact analysis is manual, slow and error-prone.
Teams discover terminology drift too late — after mappings, study builds or downstream systems have already diverged.
( Solution )
One governed catalog for connected standards
DataSDR centralizes standards, terminology, concepts, documents and relationships in a metadata repository designed for versioning, auditability and controlled releases.
( Workflow )
From import to downstream delivery
1
Import
Load CDISC, LOINC, SNOMED CT, ICD, custom codelists and client extensions
2
Curate
Maintain item-level history, documents and semantic definitions
3
Connect
Map relationships and dependencies across standards and study artifacts
4
Assess impact
Review what changes before release — CRF, DTA, SDTM, ADaM and mappings
5
Approve
Task management and review queues for governed publishing
6
Release
Package versioned bundles with audit trail and provenance
7
Publish
Deliver via API to EDC, analytics, submission and operational systems
Built for standards governance at scale
Item-level history
Track every change with releases, rollback visibility and provenance.
Audit trail
Supports auditability for regulated metadata workflows.
Dependencies & relationships
Understand how terminology connects across study and submission artifacts.
Impact assessment
See downstream effects before publishing terminology or mapping updates.
Task management
Review queues for curators, stewards and approvers.
Reports & metrics
Operational visibility into standards health and release activity.
Document repository
Store supporting specifications alongside governed terminology.
Backups
Protect governed metadata with controlled backup workflows.
( Enterprise integration )
API-first delivery into your stack
- API-first architecture for downstream tools and automated pipelines
- Single sign-on with Entra ID, Okta and enterprise identity providers
- Role-based access control for curators, reviewers and consumers
- Supports integration with EDC, analytics, data management and submission workflows
( Business value )
Less manual reconciliation, clearer provenance
- Reduce manual spreadsheet reconciliation across study teams
- Improve reuse of controlled terminology and client extensions
- Make version management explicit instead of implicit in file names
- Help teams maintain traceability as standards evolve
Built from real standards-governance work
DataSDR's approach is based on practical experience building standards infrastructure for a global pharmaceutical environment, where clinical standards were connected across data collection, data delivery and analysis workflows.
Challenge
Connected standards were maintained across file-based tables, with manual change-impact analysis and limited reuse across study builds.
Result
A governed metadata platform with releases, audit trail, impact assessment and downstream integration — now managing business-critical standards in production use.
Standards we understand
CDISC · SDTM · ADaM · LOINC · SNOMED CT · ICD-10-GM · Alpha-ID-SE · Custom codelists
DataSDR is designed to manage evolving standards, controlled terminologies and organization-specific extensions in a governed catalog — not to certify or validate external standards.
Evaluate your standards workflow
Book a no-cost 30-minute audit of how your team manages connected standards, terminology and releases.
Book a 30-min standards audit