ADaM package generation has long been one of the most persistent bottlenecks in clinical development, often consuming over two months across specification creation, programming, and QC. These delays directly impact regulatory timelines and patient access.
Saama’s recent webinar demonstrated how these timelines can be radically reduced. With the ADaM Navigator, specification development dropped from 27 to 9 days, and programming efforts from 36 to 14 days. This marks a transformational shift in how clinical programming gets done.
The Technology Behind the Transformation
As part of Saama’s Biometrics Research and Analysis Information Network, the ADaM Navigator applies Agentic AI to interpret SAPs, design domain strategies, and generate production-ready ADaM specifications and code, in minutes rather than weeks.
Core capabilities include:
- Automated SDTM to ADaM transformation with intelligent domain mapping
- SAP analysis and endpoint identification
- Domain hierarchy planning and dependency management
- Specification generation aligned to CDISC ADaM IG v1.1
- Reusable SAS and R code creation following industry best practices
- Built-in quality, traceability, and audit-ready compliance features
Demonstrated Performance Impact
The webinar showcased measurable improvements that directly address key programming challenges:
- 66% reduction in ADaM specification creation and approval time (27 → 9 days)
- 61% acceleration in programming and QC (36 → 14 days)
- Full ADaM specification generation in minutes
- Up to 70% reduction in programming time through intelligent automation
These results translate to faster timelines, reduced manual effort, improved submission readiness, and greater programming consistency across studies.
The 7-Step Agentic AI Approach to ADaM Generation
The ADaM Navigator follows a structured, stepwise process that replicates expert planning while delivering scalable, compliant outputs at speed:
1. SAP Deconstruction
Agentic AI parses the Statistical Analysis Plan (SAP) to identify endpoints, analysis objectives, missing data rules, and derivation requirements.
2. Analysis-to-SDTM Mapping
Maps each analysis to its corresponding SDTM domains and variables, ensuring accurate input alignment for downstream derivations.
As teams unlock major time savings with AI-driven ADaM workflows, many are now fast-tracking SDTM development as well. Saama’s earlier session on SDTM autogeneration shows how our Agentic AI accelerates both spec creation and programming- now available to watch on demand.
3. ADaM Domain Determination
Identifies which ADaM domains are required (e.g., ADSL, ADLB, ADAE, ADTTE) and in what sequence they should be built.
4. Domain Hierarchy & Flow Design
Defines dependencies and relationships between domains to ensure logical flow and traceability.
5. Variable & Metadata Structuring
Generates variable-level specifications including derivation logic, controlled terminology, and sponsor-specific metadata.
6. Specification Generation (Define-XML 2.1 Format)
Outputs submission-ready specifications in spreadsheet format aligned to Define-XML 2.1 standards.
7. Code Generation & Validation
Produces high-quality, reusable SAS or R code, with built-in documentation and validation logic that meet industry and sponsor requirements.
This end-to-end approach significantly reduces programming effort while maintaining transparency, traceability, and regulatory compliance. It frees biostatistics teams to focus on strategic tasks instead of manual data transformation.
What’s Available Now- and What’s Next
Saama’s biometrics platform is evolving rapidly to support the full spectrum of clinical data automation.
- SDTM Navigator is already available for sandbox, pilot, and production deployments
- ADaM Navigator is now open for sandbox access and pilot use starting next week, with production deployments available beginning October.
- TLF Navigator is slated for release in the first half of next year, with a preview demo and webinar coming in September. Sandbox access will be considered starting October.
Whether you’re exploring the platform in a sandbox environment, initiating a pilot, or scaling into production, we’re ready to support you at every stage- write to us at [email protected] to get started.
Conclusion: AI That Enables, Not Replaces
The ADaM Navigator represents a fundamental shift in how programming teams approach analysis dataset creation. Rather than replacing human expertise, it augments it, providing structured, intelligent support that accelerates delivery while upholding standards.
By combining speed, precision, and adaptability, Saama’s Agentic AI platform helps clinical teams reduce time-to-submission, optimize resource utilization, and deliver on the promise of faster, more efficient drug development.
Access the on-demand webinar to see the ADaM Navigator in action.
