Clinical Development · Biostatistics
Statistics That
Survive Review.
SAP development, SAS and R programming, TFLs, and submission-ready statistical packages built to regulatory standard from protocol stage.
DoubleProgrammed
Overview
The Full Statistical Lifecycle
Our biostatistics services cover the full statistical lifecycle of a clinical programme — from SAP development at protocol stage through to submission-ready statistical reporting for NDA, MAA, and BLA applications. Statistical programming CRO support from Vigilare Biopharma means your analysis datasets, tables, listings, and figures are produced to the standard that FDA and EMA statistical reviewers expect, with complete traceability from raw data to reported results. Sponsors who engage our biostatistics services early — at protocol design, not after database lock — consistently produce cleaner submissions with fewer post-submission statistical queries.
- SAP development at protocol stage
- SAS and R programming to CDISC ADaM
- Independent double-programming validation
- ISS/ISE integrated submission packages
What We Deliver
Capabilities Across Every Stage
Three integrated disciplines, delivered by senior specialists as one accountable programme.
Statistical Programming & Analysis
Our SAS programming services produce analysis datasets, TFLs, and submission packages that meet current CDISC ADaM specifications and FDA technical standards. R programming clinical trials support is available for sponsors working in open-source environments or requiring specific analytical methods where R-based approaches are more appropriate. Statistical analysis clinical trials work begins with the SAP — a pre-specified document defining all analysis methods, estimands, and missing data handling before a single data point is analysed. Clinical programming services cover SDTM and ADaM dataset production, define file creation, and reviewer's guide preparation as a complete submission package.
SAS & R Expertise
Our SAP development process engages with your medical and regulatory teams at protocol stage to ensure endpoints, estimands, and analysis populations are statistically defensible from the outset. Tables listings figures are produced to regulatory format specifications with full source-data traceability — every cell in every table references the dataset and variable from which it was derived. Clinical data analysis outputs are validated through independent double-programming: two programmers produce outputs independently and discrepancies are resolved before any result is considered final. CRO biostatistics services at this level of validation are a submission risk-reduction measure, not an overhead.
Trial Data Insights
Trial statistics support extends beyond dataset production to the full statistical narrative your regulatory submission requires. Statistical reporting pharma experience means we know what FDA and EMA statistical reviewers focus on — and we build submissions that address those focus areas proactively. Clinical programming services for integrated submissions include ISS and ISE programming across multiple studies, with pooled datasets built to a consistent ADaM architecture. For sponsors requiring global biostatistics services CRO USA EU support under a single statistical team, we provide coordinated delivery with agency-specific formatting applied in each jurisdiction — statistical programming worldwide.
SAS + RProgramming
5Global Regions
E9(R1)Estimands Ready
ISO 90012015 Quality System
Key Deliverables
What You Receive
Tangible, submission-ready outputs — not status updates.
Statistical Analysis Plan (SAP)
Pre-specified plan defining all statistical methods, estimands, sensitivity analyses, and missing data handling.
Analysis Datasets (SDTM / ADaM)
CDISC-compliant datasets with define files, reviewer's guides, and double-programming validation documentation.
Tables, Listings & Figures (TFLs)
All CSR outputs formatted to regulatory standards with full dataset traceability.
ISS / ISE
Integrated summaries of safety and efficacy across the development programme for NDA/MAA submissions.
Statistical Report
Submission-ready report interpreting results against the pre-specified SAP and applicable regulatory guidance.
Why Vigilare
Why Sponsors Choose Vigilare
What sets this engagement apart from a generic vendor.
SAP at Protocol Stage
SAP development at protocol stage — not after database lock — ensuring that every analysis decision is pre-specified and defensible under regulatory scrutiny.
Double-Programming Standard
Independent double-programming validation as standard for all TFLs and analysis datasets — the same quality standard FDA expects, applied to every deliverable regardless of study size.
SAS & R Capability
SAS and R capability across all major programming environments, with biostatisticians experienced in estimands methodology under ICH E9(R1) — increasingly required by FDA and EMA reviewers.
Direct Submission Support
Direct regulatory submission support for FDA, EMA, MHRA, PMDA, and TGA — with agency-specific formatting and technical standards applied as a standard part of every deliverable.
Who We Work With
Configured to Your Model
We engage differently depending on the function you already have in place.
NDA / MAA / BLA Submitters
Challenge
Need submission-ready CDISC datasets, TFLs, and statistical reports meeting regulatory standards
How We Help
Fully validated datasets and outputs with complete reviewer documentation and define files.
Clinical Stage Sponsors
Challenge
Require SAP development and statistical support without a large internal biostatistics function
How We Help
We act as your statistical team from SAP development through final reporting across all study phases.
Complex Trial Designs
Challenge
Running adaptive, platform, or seamless designs requiring specialist methodology
How We Help
Senior biostatisticians with direct experience in complex designs and regulatory acceptance criteria.
FAQs
Biostatistics & Programming, Answered.
01
What is biostatistics in clinical trials?
Biostatistics in clinical trials is the application of statistical methods to study design, data analysis, and result interpretation in ways that meet regulatory evidentiary standards. It covers sample size calculation, randomisation, SAP development, dataset programming, and production of the statistical outputs that form the core of a regulatory submission. Biostatistical input at protocol stage shapes the entire analytical framework of a study.
02
What is SAS programming?
SAS (Statistical Analysis System) programming is the primary tool used in clinical trials to produce CDISC-compliant analysis datasets, tables, listings, and figures for regulatory submissions. FDA technical standards for electronic submissions are built around SAS dataset formats and macro libraries, making SAS programming expertise a core requirement for NDA, MAA, and BLA submission packages. Independent double-programming in SAS is the standard validation approach for submission outputs.
Related Services
Complete the Clinical Programme
Pair this with the other clinical functions that run alongside it — one team, one quality system.
Ready for a defensible analysis?
Speak to our team about your programme requirements. We respond within one business day.