IDDCR Global Research
Rare DiseaseCDISC StandardsPhase II / III

CDISC SDTM Automation Across a 12-Study Rare Disease Programme

Rare Disease Biotech

60%+
Reduction in programming effort
12
Studies delivered on schedule
0
Critical FDA validation findings
01

The Challenge

A rare disease biotech needed SDTM-compliant datasets across 12 studies with heterogeneous EDC configurations, facing an FDA submission deadline in 14 months.

02

The IDDCR Approach

iClinicalAI was configured to automate SDTM mapping, validation and define.xml authoring across all 12 studies, with IDDCR statistical programmers providing oversight and regulatory review.

03

The Outcome

Programming effort reduced by over 60%. All 12 study SDTM packages delivered on time. Zero critical Pinnacle 21 findings at FDA review.

  • 60%+ — Reduction in programming effort
  • 12 — Studies delivered on schedule
  • 0 — Critical FDA validation findings

"The iClinicalAI-driven SDTM automation gave us a level of consistency and speed across 12 studies that would have been impossible with a traditional programming approach."

Head of Biometrics

Rare Disease Biotech

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