Statistical Programming using SAS & R
CPVIA provides biostatistics & statistical programming services to its clients in the entire clinical development cycle — protocol development, study design, statistical analysis, and regulatory submission. Trained and competent professionals at CPVIA are well-equipped to provide insightful analysis and reporting of clinical study data that enables clients to draw inferences and make well-informed decisions.
"Our focus is to add value to the clients with our expertise in standard statistical reporting tools and systems."
Our team is dedicated to providing services in compliance with current industry standards and regulatory guidelines. 21CFR Part11 compliant systems and well documented SOPs are the backbone for project implementation. We are up-to-date with evolving industry standards, changes in the regulatory environment, and enhancements in technology and applications.
The wide repertoires of projects we have delivered span multiple therapeutic areas across the drug development lifecycle. Our focus on automation and process optimization, combined with the ability to customize solutions tailored for client-specific environments, make us a trusted partner with pharmaceutical companies and CROs to deliver high-quality analysis results.
With global presence and a team of expert biostatisticians and SAS programmers, CPVIA is uniquely positioned to provide a wide range of biostatistics and statistical programming services to clients in a space where timely delivery and accuracy are of paramount importance.
R Programming for Modern Clinical Trials
The clinical programming industry is undergoing a profound transformation. R has become the leading open-source platform for pharmaceutical data analysis, driven by regulatory acceptance, cost advantages over SAS, and a thriving pharmaverse ecosystem. The FDA confirmed this shift in 2023–2024 when the R Consortium successfully submitted ADaM datasets generated entirely in R — validating open-source tools as a viable regulatory pathway.
CPVIA offers expert R programming services that deliver submission-ready outputs with the same rigour and precision as traditional SAS workflows. Our programmers are proficient across the full pharmaverse stack — a curated ecosystem developed by Roche, GSK, AstraZeneca, Novo Nordisk, and others — enabling efficient, reproducible, and fully validated clinical deliverables.
We support both standalone R engagements and hybrid SAS+R environments, giving sponsors and CROs the flexibility to transition at their own pace while maintaining regulatory compliance.
⚡ R Clinical Programming Services
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SDTM dataset creation and domain mapping using
sdtm.oakandadmiral - • ADaM dataset development — ADSL, ADAE, ADTTE, ADLB, ADCM, ADEX
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Tables, Listings & Figures (TLF) generation with
rtables,gt, andggplot2 - • Statistical Analysis Plan (SAP) programming and independent validation
- • Integrated Summary of Safety (ISS) and Efficacy (ISE) programming
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PK/PD analysis using
nlmixr2,mrgsolve, NONMEM post-processing, PK parameter derivation, and reporting in R -
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XPT export and validation using
xportrfor eCTD submission - • Pinnacle 21 / define.xml generation and compliance validation
- • Shiny and teal applications for safety monitoring and data review
- • R Markdown / Quarto for reproducible clinical study reports
- • SAS to R migration — macro conversion, parallel validation, documentation
Statistical Input to Protocol / Study Design Development
Expert statistical guidance integrated in protocol development — defining endpoints, methodologies, and populations aligned with ICH E9 and regulatory expectations.
Sample Size Estimation
Rigorous power calculations and sample size justification using validated statistical models for all therapeutic areas and trial designs — Phase I through confirmatory studies.
Randomization Schedule
Generation and validation of stratified, block, and adaptive randomization schedules with full audit trail documentation and regulatory compliance.
Review of CRF and Data Management Plan
Statistical review of Case Report Forms and DMP to ensure data collection aligns with analysis requirements and CDISC standards from the outset.
Statistical Analysis Plan (SAP) and Mock-up Shells
Comprehensive SAP review aligned with protocol and regulatory guidelines, including annotated mock-up shells for TLFs and pre-specified analyses.
Analysis of Safety, and Efficacy Data for CSR and Regulatory Submissions
End-to-end statistical analysis for Clinical Study Reports — production quality TLFs, statistical summaries, and eCTD-ready submission packages.
SAS Programming - SDTM/ADaM Datasets and Tables, Listings, Figures
Validated SAS programming for CDISC-compliant SDTM and ADaM dataset creation, TLFs generation, and data manipulation following regulatory quality standards.
Design and Deployment of System-Level SAS Macros
Development of standardized, reusable macro libraries for scalable output generation, reducing programming time and manual error rates significantly across projects.
PK/PD Analysis
Non-compartmental and compartmental pharmacokinetic/pharmacodynamic analysis with Phoenix WinNonlin, SAS, or R — supporting FIH through NDA submissions.
Integrated Safety and Efficacy Analysis (ISS/ISE)
Pooled cross-study analyses for Integrated Summary of Safety and Efficacy — supporting NDA, BLA, and MAA submission requirements with full data integration.
Analysis for BA/BE Studies and Meta Analysis
Bioavailability and bioequivalence study analysis along with systematic meta-analysis supporting product labeling and regulatory decision-making.
CDISC Implementation Service
Full lifecycle CDISC implementation — CDASH CRF design through SDTM mapping to ADaM datasets — ensuring submission readiness with define.xml and reviewer guides.
Support for Safety Monitoring, Interim and Exploratory Analysis, Manuscripts and Abstracts
Blinded and unblinded interim analyses, DMC packages, adaptive design adjustments, and scientific writing support for manuscripts and conference abstracts.
Patient Profiles and Safety Narratives
Detailed patient-level data listings and individual safety narratives for serious adverse events — formatted to FDA and EMA submission specifications.
Statistical Report Writing
Comprehensive clinical statistical report authoring — covering study summaries, methodology sections, results narratives, and regulatory submission-ready documentation packages aligned with ICH E3 and agency guidelines.