Statistical Programming
From SAP receipt to submission-ready SDTM, ADaM, TLFs, and define.xml, our programmers deliver validated, audit-ready outputs across study types and regulatory pathways.
Programming Built for Regulatory Review
Statistical programming at IQA transforms SAPs into submission-ready datasets, tables, listings, and figures built for efficient regulatory review. Our programmers work across SAS, R, and Python to deliver CDISC-aligned outputs with traceability, validation, and audit-ready documentation embedded into every deliverable.
With Clinevra-enabled automation, we accelerate downstream programming by converting protocol and study metadata into reusable specifications, SDTM/ADaM-aligned programming inputs, Define-XML-ready content, and traceable submission assets. Across clinical trials, BA/BE, medical devices, RWE, HEOR, and IIT programs, we support structured QC, automated comparison, and reconciliation workflows that improve consistency, speed, and reviewer confidence.
How We Strengthen Delivery
End-to-End Statistical Programming Across Study Types
Clinical, nonclinical, RWE/HEOR, epidemiology, device, and registry programming support for submission-ready and decision-ready outputs
Standards, Metadata & Submission Assets
- SAS, R, and Python programming
- SDTM specifications, datasets, and SDRG
- ADaM specifications, datasets, and ADRG
- SEND specifications, datasets, and nSDRG
- Define-XML generation
- Annotated CRF creation and metadata support
TLFs, Analysis & Reporting
- Safety and efficacy TLF programming
- Statistical analysis programming
- PK/PD and exposure-response programming
- ISS / ISE programming support
- CSR statistical outputs
- Exploratory and ad hoc analysis outputs
Quality, Validation & Double Programming
- Independent double programming for production and QC
- Offline data checks and validation programming
- Automated compare and reconciliation workflows
- Pinnacle 21 validation support
- Reviewer-ready QC documentation
- Audit-ready traceability across deliverables
Specialty Analytics & Advanced Programming
- Interim analysis support
- DMC / DSMB data cuts and outputs
- RWE / HEOR programming
- Epidemiology and registry data analysis
- Custom R packages and Python utilities
- Clinevra-enabled accelerators, templates, and libraries
From Source Data to Submission-Ready Outputs
Structured workflows across metadata, SDTM production and QC, ADaM, TLFs, validation, and regulatory delivery.
Metadata, Annotation & Specification Setup
eCRF review, annotated CRFs, controlled terminology, source-to-target mapping, SDTM specifications, ADaM planning, and standards alignment
SDTM Production, QC & Validation
SDTM production programming, independent QC programming, dataset validation, Pinnacle 21 checks, discrepancy resolution, and Define-XML-ready metadata
ADaM & Analysis Programming
SAP review, derivation finalization, ADaM specifications, analysis dataset construction, and analysis-ready metadata
TLF Production & Validation
Tables, listings, figures, output QC, traceability checks, and CSR statistical output generation
Submission & Delivery
Reviewer guides, Define-XML, submission-ready packages, regulatory response support, and post-submission updates
Technology That Strengthens Modern Statistical Programming
Our programming environment combines validated tools, automation workflows, version-controlled development, and GxP-aligned deployment to support submission-ready delivery.
Statistical Programmers Who Think Beyond Code
Submission-ready programming strengthened by automation, independent QC, cross-functional alignment, and reviewer-focused delivery.
Full Spectrum Coverage
Clinical, BA/BE, medical device, RWE/HEOR, epidemiology, and IIT programming support across study types and regulatory pathways.
Automation by Default
Validated macro libraries, reusable templates, and Clinevra-enabled accelerators help improve consistency, reduce manual effort, and speed delivery.
Dual Programming. Always.
Independent production and QC programming, automated compare checks, and discrepancy reconciliation are built into every delivery workflow.
Multi-Agency Package Expertise
Programming outputs aligned to the expectations of FDA, EMA, PMDA, CDSCO, and other global review environments.
Integrated with Biostatistics & CDM
Our programmers work alongside biostatistics and data management teams to maintain traceability from metadata and source data through submission outputs.
CDQOps-Powered Quality Checks
Automated cross-dataset validation, standards review, and proactive quality checks strengthen delivery beyond standard validation alone.
Built for Submission. Ready for Review.
We help sponsors deliver validated datasets, TLFs, and programming outputs with the quality and traceability regulators expect.