Biometrics & Statistical Sciences
Biostatistics Consulting Services
Statistical thinking applied at the earliest design decisions, so that each study is built to answer the questions it needs to answer. Our biostatistics consulting services cover the statistical side of a study from the first design decisions onward.
Overview
Our biostatisticians support clinical development programs at the points where statistical choices shape the evidence: the protocol, the sample size, the endpoints and the analysis strategy behind them.
We work with adaptive designs and Bayesian methods where they fit the question, and we support the statistical side of regulatory interactions.
What we do
Protocol statistical design, sample size, endpoint strategy, adaptive and Bayesian designs, and regulatory interactions.
Consulting scope
- Protocol statistical design
- Sample size calculations
- Endpoint strategy
- Adaptive designs
- Bayesian methods
- Regulatory interactions
Frequently asked questions
What is biostatistical consulting?
Expert statistical advice on how a study is designed, analyzed and interpreted, covering the protocol, endpoints, sample size, analysis strategy and regulatory interactions.
How is sample size calculated for a clinical trial?
From the primary endpoint, the effect to detect, expected variability or event rate, significance level and power, plus an allowance for dropout.
What is an adaptive design?
A trial design that allows planned changes based on accumulating data, such as stopping early or dropping an arm. Every adaptation rule is pre-specified.
Do you use Bayesian methods in trial design?
Yes. We work with adaptive designs and Bayesian methods where they fit the question being asked.
Can you support statistical discussions with regulators?
Yes. We support the statistical side of regulatory interactions, alongside protocol statistical design, sample size calculations and endpoint strategy.
Contact our team
Share your study, submission or evidence need and we will come back to you on scope and next steps for Biostatistical Consulting.
Start with what you need