Biostatistics is at the heart of every clinical study, driving study design, study conduct, data collection, analysis, and reporting. Our biostatisticians work closely with the entire project team throughout the study to ensure that the correct data is captured and ready for analysis. Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout clinical development.
End-to-End Biostatistics in Clinical Development
Clean, submission-ready data doesn't happen by accident, it's the result of biostatisticians who understand your therapeutic indication as well as they understand the statistics. We have extensive experience providing strategic statistical consulting and services from study design and protocol development to study analysis through regulatory submission and agency meeting representation. Our statistical experience includes pre-clinical, clinical, registration phase, and post-marketing studies.
Bringing a novel therapeutic to market always comes with unknown challenges. Engage our biostatisticians to support clinical trial planning and biostatistical analysis, regulatory submissions, and research and manufacturing development, or partner with us to make our biostatistics team an extension of yours.
Our statistical experience spans pre-clinical, clinical, registration-phase, and post-marketing studies, so your program has consistent statistical thinking behind it from first protocol to final label.
Flexible by design.
Need support on a single trial or submission? We're ready. Need a full biostatistics team embedded in your organization?
Adaptive design fluency.
From simulation to implementation, our biostatisticians bring real experience planning and executing adaptive clinical trial designs, not just running the standard fixed-design playbook.
Independent oversight when it matters.
Our biostatisticians support Data Monitoring Committee services, bringing the statistical rigor DMCs depend on to protect patient safety and trial integrity
Estimand-driven from the start.
We apply the ICH E9(R1) estimand framework to align your trial objective, endpoints, and analysis before the protocol is finalized, defining how intercurrent events and missing data are handled up front rather than patching it in the SAP later.
PROOF POINTS
12+ years average industry experience per biostatistician
600+
biostatistics-supported oncology projects during the last five years
36+
regulatory submissions supported with biostatistics services in the past 5 years, spanning NDA, BLA, MAA, and sNDA filings
Tailored Biostatistics Services
Study Design & Planning.
Study design, protocol development, sample size calculations, endpoint development, and randomization.
Strategic & Adaptive Design Consulting.
Strategic statistical consulting and adaptive design clinical trial planning, simulation, and implementation.
Statistical Analysis & Reporting.
Statistical analysis plans (SAPs), statistical tables, data listings and figures for CSRs, interim analyses, and post hoc or exploratory analyses.
Data Oversight.
Data Monitoring Committee (DMC) services and eCRF design and review.
Regulatory & Publication Support.
Regulatory submissions, including guidance, planning, and meeting representation, along with abstract and publication writing.
Integrated Safety & Efficacy Analyses.
ISS/ISE analyses spanning your full submission package.
What's Next in the Drug Development Process
Medical Writing
Turn your statistical outputs into clear, submission-ready clinical and regulatory documentation.
Data-Driven Strategies to Advance Development and Approval of ...
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Advancing Oncology Innovation
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Know what your data is telling you.
Statistical analysis should do more than produce results. Veristat’s biostatisticians combine scientific rigor, therapeutic expertise, and statistical thinking to interpret your data in the context of your development program, giving you clearer direction for the decisions that shape what comes next.
Biostatisticians handle study design, statistical analysis plans, and the interpretation of trial data, while statistical programmers translate that plan into the actual programming that generates datasets, tables, listings, and figures, the two roles work closely together but cover distinct parts of the process.
Yes. Veristat's biostatisticians provide adaptive design planning, simulation, and implementation, helping sponsors build trials that can evolve based on accumulating data rather than committing to a fixed design upfront.
Yes. Sponsors can engage Veristat's biostatisticians for project-based support on a specific trial or submission, or partner through an FSP model to make Veristat's biostatistical team a dedicated extension of their own.
Yes. Veristat's biostatisticians provide DMC services, delivering the independent statistical analysis and reporting DMCs rely on to monitor patient safety and trial integrity throughout a study.
