Clinical Consulting • Data Modernization

USDM & Dataset-JSON
Readiness

The FDA is replacing SAS V5 XPORT, a binary format from 1989, with Dataset-JSON. Simultaneously, CDISC USDM is redefining study definition standards. INNOVIZZ helps clinical organizations assess and modernize their data pipelines for both transitions with production-tested automation and hands-on regulatory expertise.

Schedule Readiness Assessment
Production-Validated
JSON ETL pipeline deployed in clinical trials
Zero
Manual intervention in pipeline architecture
2 - 4 Yr
Estimated compliance window
6,000+
Estimated active sponsors affected

This service offering is in active development. Metrics are based on prior clinical programming engagements and publicly available industry estimates. Individual results will vary based on organizational data maturity, pipeline complexity, and scope of engagement.

Regulatory Signal

The FDA has published its intent to deprecate XPT and make Dataset-JSON the transport format for regulatory submissions. This is not prediction. It is observation of what is already in motion.

FDA Federal Register Notice • Docket FDA-2025-N-0129 • Published April 9, 2025 • 42 industry comments received as of publication • FDA-CDISC-PHUSE pilot completed April 2024

No formal mandate date or enforcement deadline has been announced by the FDA. The regulatory landscape surrounding Dataset-JSON adoption and XPT deprecation is actively evolving. Information presented here reflects publicly available regulatory signals as of the date of publication and is subject to change.

The Operational Reality

Your Submission Pipeline Was Built
for a Format Being Retired

Every clinical organization submitting to the FDA relies on XPT. Most are aware Dataset-JSON is coming. Few have begun actively preparing. The gap between awareness and action is where submission risk compounds.

Format Obsolescence

XPT constrains variable names to 8 characters, values to 200 characters, offers no Unicode support, and uses binary-only encoding. A 1989 format constraining modern clinical data in every single submission.

Regulatory Uncertainty

No formal mandate date announced yet, but the pilot is done, the Federal Register notice is published, and parallel acceptance is imminent. Waiting for the deadline is not a strategy. It’s a risk.

Pipeline Fragility

Current submission pipelines are hardcoded to XPT generation. Define-XML linkage, Pinnacle 21 validation, downstream TLF workflows: all assume a format that’s being deprecated beneath them.

Talent & Tooling Gap

Pinnacle 21 v4.1.0 doesn’t fully support Dataset-JSON v1.1. Most internal teams have never generated it. No widely adopted playbook exists. The gap between “aware” and “ready” is wider than most organizations realize.

Technical observations are based on publicly available tool documentation, CDISC specifications, and FDA publications as of the date of this page. Tool capabilities (including Pinnacle 21 and SAS platform support for Dataset-JSON) are actively evolving and may have changed since the time of writing. Organizations should verify current tool versions and vendor roadmaps independently.

What We Deliver

Three Tiers of Readiness

Start with assessment. Scale to full implementation. Every tier is designed to produce auditable, production-grade deliverables. Tier 1 works as a standalone engagement or as the entry point to a broader transformation.

01

Readiness Assessment & Gap Analysis

2–12 Weeks

Comprehensive audit of your current submission pipeline against Dataset-JSON v1.1 and USDM requirements. Identifies critical gaps and produces a prioritized remediation roadmap.

  • Current-state pipeline audit (XPT, Define-XML, Pinnacle 21)
  • Dataset-JSON compatibility assessment
  • USDM alignment evaluation
  • Risk-prioritized remediation roadmap
  • Executive readiness scorecard
02

Dataset-JSON Pipeline Build

6–28 Weeks+ (depending on complexity)

Dataset-JSON generation pipeline development with bidirectional SAS-to-JSON conversion, metadata enrichment, and validation integration tailored to your existing toolchain.

  • Automated Dataset-JSON generation
  • Bidirectional SAS ↔ JSON conversion
  • Define-XML metadata enrichment
  • Pinnacle 21/CORE validation integration
  • QA framework & regression testing
03

Full USDM & DDF Implementation

16–38 Weeks

End-to-end Digital Data Flow architecture and implementation consulting. USDM-compliant study definition design, API exchange specification, and AI-assisted protocol digitization, delivered in partnership with your internal engineering and standards teams.

  • USDM Study Definitions architecture design
  • API exchange specification (EDC/CTMS/eTMF)
  • SDTM Trial Design population framework
  • ICH M11 protocol template alignment
  • AI-assisted protocol digitization consulting

Timelines reflect average expectations assuming existing structured data standards with validated mapping specifications. For engagements requiring a complete rework of data standards or pipeline architecture, timelines will vary depending on project scope and complexity.

USDM & Dataset-JSON Readiness is a specialized service offering currently in active development. Tier structures, deliverables, and scope descriptions presented here represent our proposed engagement framework and may be refined as regulatory requirements and industry standards continue to evolve.

Engagement Model

Assessed. Architected. Deployed.

Every phase is structured to produce auditable deliverables. Each phase builds on validated outputs from the prior, ensuring no gaps carry forward.

Phase 1
Readiness Audit
2 – 12 Weeks
  • Pipeline assessment
  • Tool compatibility
  • Gap identification
  • Remediation roadmap
  • Executive scorecard
Phase 2
Architecture & Build
6 – 28 Weeks+
  • JSON pipeline development
  • SAS ↔ JSON converters
  • Define-XML integration
  • USDM schema design
  • Validation framework
Phase 3
Validation & Deploy
16 – 38 Weeks
  • GxP validation
  • Pinnacle 21 integration
  • Team training
  • Knowledge transfer
  • Documentation handover
Ongoing
Continuous Compliance
Retainer (limited availability)
  • FDA mandate tracking
  • Version upgrades
  • Pipeline optimization
  • Standards evolution
  • Periodic reviews

The phased engagement model is a proposed framework designed to be tailored to each organization's specific data maturity, toolchain, and regulatory posture. Phase sequencing, deliverables, and durations will be scoped during the initial consultation and formalized in a Statement of Work prior to engagement.

Fit Assessment

Who This Is For

USDM & Dataset-JSON Readiness is designed for organizations where submission pipeline modernization directly impacts regulatory timelines and competitive positioning.

VP / Directors of Biometrics

Responsible for submission-ready datasets across multiple studies. Need to understand readiness gaps before regulatory deadlines compress timelines.

Clinical Data Management

Managing data pipelines from EDC through submission. Current workflows hardcoded to XPT with no Dataset-JSON capability in the toolchain.

Clinical IT & Standards Teams

Evaluating tool readiness (Pinnacle 21, SAS, R, Python) for Dataset-JSON v1.1. Need expert architecture guidance during the transition window.

CRO Data Operations

Multi-sponsor environments maintaining compliance across both XPT and Dataset-JSON during parallel acceptance. Standardization across sponsors is critical.

The roles and organizational profiles described above represent typical engagement scenarios and are not exhaustive. INNOVIZZ evaluates each prospective engagement individually to determine mutual fit and feasibility. Service availability may be subject to capacity constraints as a boutique consultancy.

2 - 38 Weeks
Assessment Through Full USDM Implementation
Scoped to organizational complexity, data maturity, and selected tier
Next Step

Request a Dataset-JSON
Readiness Assessment

A confidential 30-minute technical conversation about your current submission pipeline, Dataset-JSON readiness gaps, and recommended preparation approach.

Complimentary No obligation Practitioner-led
Schedule Assessment

This service offering is currently in exploratory development. All descriptions of tiers, deliverables, timelines, and engagement models represent INNOVIZZ's proposed framework and are subject to refinement. The initial consultation is designed to assess mutual fit and determine scope. No contractual commitment is implied by scheduling a consultation or by the content presented on this page. Regulatory references are based on publicly available information and do not constitute legal or compliance advice.