Clinical Trial Statistical Programming Services
Shafi Consultancy delivers end-to-end Phase I–IV statistical programming to pharmaceutical, biotech, and CRO sponsors across the UK, Europe, and North America. From raw EDC data conversion to CDISC SDTM, ADaM, ISS/ISE pooling, and CSR-ready Tables, Listings, and Figures (TLFs), you work directly with senior SAS specialists.
End-to-end statistical programming capabilities
Every clinical study demands complete traceability from raw data capture to regulatory filing. Our programming teams handle the entire biometrics scope under strict SOPs.
Tables, Listings and Figures (TLFs)
Production and validation of clear, publication- and submission-grade safety and efficacy tables, patient data listings, survival curves, forest plots, and shift tables for interim cuts, DSMBs/DMCs, DSURs, and final Clinical Study Reports (CSRs).
PK/PD & NONMEM Programming
Population PK/PD input files, WinNonLin datasets, and submission-compliant ADPPK domains with covariate summaries and individual patient anomaly plots.
Explore PK/PD & NONMEMCDISC SDTM & ADaM Datasets
Standards-compliant specification writing, raw-to-SDTM mapping, and analysis-ready ADaM dataset derivation (ADSL, ADAE, ADTTE, ADLB, ADQS) accompanied by Annotated CRFs, Define-XML 2.0/2.1, and Study/Analysis Data Reviewer’s Guides.
Explore CDISC servicesISS & ISE Data Pooling
Harmonisation and integration of multi-trial clinical databases (including legacy non-CDISC studies) for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) regulatory modules.
SAS Automation & Metalytics
Metadata-driven reporting through our in-house Metalytics platform and validated SAS macro repositories—eliminating black-box code while accelerating database lock turnaround.
Onsite & Offsite Remote Programming Support
Flexible resourcing that fits how your team works. Our statistical programmers can join your programming team onsite at your premises, or deliver remotely from our UK and Bangladesh offices, working to your SOPs, tools and timelines. Support can scale up or down across studies, from individual deliverables to full study programming.
Discuss your resourcing needsRigorous validation and independent QC workflow
Submission readiness is built into every step rather than bolted on at database lock. Our programmers adhere to strict Good Programming Practice (GPP) and double-programming verification.
SAP & Shell Review
Early programmer review of the Statistical Analysis Plan, mock TLF shells, and edit-check rules to catch ambiguities upfront.
Specification & SDTM
Machine-readable mapping specifications and raw EDC/lab transformation into CDISC SDTM domains with data issue tracking.
ADaM Derivation
Traceable analysis datasets implementing complex censoring, imputation, baseline flags, and therapeutic endpoint windows.
Automated TLF Build
Consistent generation of in-text and post-text tables, listings, and SGPLOT figures driven by validated macro templates.
Double QC & Pinnacle 21
100% independent parallel programming, automated SAS log scanning, and Pinnacle 21 validation for zero-discrepancy sign-off.
Flexible resourcing built around your biometrics team
Whether you need an autonomous programming team for an entire clinical programme or embedded specialists operating inside your computing environment, we scale without bureaucracy.
Therapeutic & Trial Breadth
Extensive Phase I–IV and mega-trial (up to 16,000+ patients) programming experience across Oncology (RECIST 1.1, survival & time-to-event), Cardiovascular, Respiratory, Immunology, CNS, Metabolic Disease, and Rare Diseases.
Full-Scope Project Delivery
Fixed-scope or milestone-based delivery of SDTM, ADaM, TLFs, and eCTD submission packages managed by a dedicated Shafi Consultancy Lead Programmer with direct sponsor communication.
Functional Service Provision (FSP)
Dedicated senior statistical programmers and QC analysts working directly within your secure Statistical Computing Environment (SCE), following your SOPs, macro libraries, and CDISC governance.
Short-Notice DSMBs, Rescue & Legacy Conversions
Rapid-response programming teams for compressed database locks, unblinded DMC reporting, Risk-Based Monitoring (RBM) data checks, and legacy dataset remediation ahead of regulatory filing.
Frequently asked questions
What does clinical trial statistical programming include?
It covers Tables, Listings and Figures (TLFs), CDISC SDTM and ADaM datasets with annotated CRFs, Define-XML and reviewer’s guides, ISS/ISE data pooling, PK/PD and NONMEM programming, and SAS automation, for Phase I–IV studies.
Can your programmers work within our systems and SOPs?
Yes. Our statistical programmers can join your team onsite at your premises, or deliver remotely from our UK and Bangladesh offices, working to your SOPs, tools and timelines. Support can scale up or down across studies.
How do you check the quality of your deliverables?
We follow Good Programming Practice and use independent double programming, automated SAS log scanning and Pinnacle 21 validation, so that every deliverable is verified before sign-off.
Who do you support?
We support pharmaceutical, biotech and CRO sponsors across the UK, Europe and North America, from individual deliverables to full study programming.
Discuss your study with an expert statistical programmer
Share your trial phase, therapeutic area, and timeline, we respond within one business day from our management team.