Statistical Programming — IDDCR Global Research
Statistical Programming
Submission-ready CDISC datasets, TFLs and regulatory deliverables.
IDDCR's statistical programming team delivers high-quality SDTM, ADaM datasets and TFL programming in SAS and R — producing submission-ready deliverables that meet FDA, EMA and PMDA requirements.
Our Approach to Statistical Programming
Our programmers combine deep CDISC standards expertise with regulatory programming experience to deliver accurate, well-documented and inspection-ready programming packages. From SDTM mapping through ADaM derivation to TFL production, we apply rigorous quality control processes to every deliverable.
Core Capabilities
SDTM Dataset Programming
SDTM mapping specifications, dataset programming, reviewer's guide development and SDTM validation using Pinnacle 21 and custom validation checks.
ADaM Dataset Programming
ADaM dataset specifications, ADSL, ADAE, ADCM, ADLB, ADTTE and custom ADaM programming aligned to CDISC ADaM Implementation Guides.
Tables, Figures & Listings (TFLs)
Production of all statistical outputs — summary tables, data listings and figures — programmed in SAS or R to match SAP specifications.
Define-XML & Reviewer's Guides
Define-XML v2.1 creation, ADRG and SDRG development, and eSub package preparation for FDA, EMA and PMDA submissions.
Validation & QC
Independent double programming, output comparison, validation documentation and Pinnacle 21 compliance checks for all deliverables.
Legacy Data Conversion
Conversion of legacy datasets to CDISC SDTM and ADaM standards, supporting integrated analyses, pooled studies and regulatory submissions.
Therapeutic Areas
Development Phases
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Frequently Asked Questions
Common questions about this service — answered by our specialist team.
Need Statistical Programming Support?
Talk to our programming team about your SDTM, ADaM and TFL requirements for your next submission.