Statistical Programming provides a variety of services to understand the effect of a test product on safety, efficacy, or other points of interest. Programming works closely with our Biostatistics team to carry out planned analyses which include creation and QC of analysis datasets and tables, listings, and figures (TLFs). Our team ensures accurate results in a timely fashion. Quality control is achieved for analysis datasets, tables, listings, and figures via independent programming according to dataset specifications or the SAP, as appropriate to ensure accurate results are provided to Biostatistics before final statistical review.
Statistical Programming also provides many ad hoc analyses for publication summaries and external/internal review meetings.
Ready for programming you can trust with your submission?
Programming And Biostatistics Work Hand In Hand, And That Partnership Only Works With Accurate Data.
Every analysis dataset, table, listing, and figure goes through independent QC against dataset specifications or the SAP, so Biostatistics can focus on interpretation, backed by data they can trust.
That same discipline extends to your submission package. Our programmers develop and QC CDISC, SDTM, and ADaM datasets built for submission compliance, along with ISS and ISE analyses, so your data holds up under regulatory scrutiny, not just internal review.
HOW IT WORKS
Programming support that moves with your trial, from planning through regulatory review.
Planning Your Trial.
We build the analysis dataset and TLF framework your trial will run on, aligned to your SAP from the start.
Running Your Trial.
We support interim analyses and annual clinical trial safety updates as your trial progresses, plus DMC programming support when independent oversight is needed.
Preparing for Regulatory Review.
We develop and QC CDISC, SDTM, and ADaM datasets, along with ISS and ISE analyses, so your submission package is ready for agency scrutiny.
Our Expertise in Statistical Programming
Veristat’s Statistical Programmers average 18+ years of programming experience, long enough to have watched the changes in the industry, and work to implement the latest advances in data standards, technology, and industry requirements to create efficiency in your trial data.
18+ years
years average programming experience per statistical programmer
360+
SDTM/ADaM analysis datasets developed during the last five years
203+
regulatory submissions supported with statistical programming, including ISS/ISE packages, eCTD submission datasets, Define.xml development, and NDA, BLA, MAA, sNDA, and IND filings.
100+
DMC (Data Monitoring Committee) programming engagements supported by Veristat
Veristat's Offerings
Programming Across the Entire Development Lifecycle
Whether you need support for planning your trial, running your trial or preparing data for regulatory agency review, Veristat can support your programming needs.
CDISC, SDTM, and ADaM Submission-Ready Dataset Development and Quality Control
Submission-ready dataset development and quality control built for regulatory compliance.
ISS/ISE Analysis of Dataset Development and QC
Analysis of Dataset Development and Quality Control for Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE).
Data Monitoring Committee (DMC) Support.
Programming support behind the independent oversight your DMC depends on.
Interim Analysis Support.
Programming support for interim analyses as your trial progresses.
TLFs for ISS
Tables, Listings, and Figures Development and Quality Control for Integrated Summaries of Safety
Annual Clinical Trial Safety Updates.
Ongoing programming support for annual safety reporting requirements.
Tables, Listings, and Figures (TLF).
Development and Quality Control of the TLFs your trial's analysis depends on.
What's Next in the Drug Development Process
Biostatistics.
Turn your programmed datasets into meaningful statistical interpretation and analysis.
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Build the outputs behind better decisions.
Your clinical data has to become something your team can analyze, interpret, and act on. Veristat’s statistical programmers transform trial data into accurate, rigorously QC’d datasets and outputs, creating a reliable path from raw data to statistical interpretation, development decisions, and regulatory submission.
Standard analysis datasets support a single trial's statistical analysis, while ISS/ISE dataset development pools and programs data across multiple studies to support Integrated Summaries of Safety and Efficacy, typically required for a marketing application.
Yes. Veristat's statistical programmers support DMC programming needs, providing the datasets and outputs independent committees rely on to monitor patient safety and trial integrity throughout a study.
Both. Veristat provides programming support across a full portfolio, a specific program, an individual trial, or on an FSP basis, scaling to whatever level of support your team needs.
