Phase II and III are where the strength of your development programme is tested. We build the biometrics around the claim you need to make, so your design, your data and your submission outputs all point the same way.
In Phase II and III, scale leaves less room for weak assumptions. We define what the trial needs to demonstrate, then shape the design and analysis around that objective so the evidence stands up to regulatory review.
More patients, sites and countries bring greater complexity, variability and pressure on the data. We keep design, data management and analysis closely connected so issues are identified early and evidence quality is protected as the study scales.
Late-phase delivery depends on every biometrics workstream working towards the same outcome. With more than a third of our portfolio in Phase II and III, we know how to keep those elements connected from protocol to final evidence.
Studies focused on identifying the dose, regimen and response profile to carry forward into confirmatory development.
Programmes that combine learning and confirmation within one design, with pre-defined criteria for progressing between stages.
Large confirmatory studies designed to establish efficacy and safety for regulatory submission, including superiority, non-inferiority and equivalence trials.
Studies that use planned interim analyses to allow pre-specified changes or early decisions while preserving statistical validity.
Global studies spanning multiple countries or regions, where consistency of treatment effect and regional differences need to be properly assessed.
Studies where limited patient numbers require more tailored design choices and careful use of the available evidence.
Confirmatory clinical investigations designed to generate the evidence required for regulatory approval and CE marking.
Studies that need independent review of accumulating safety or efficacy data while the trial remains ongoing.
We define the claim first, then shape the design around what the study needs to demonstrate. Limitations are identified before they become embedded in the protocol.
We ground assumptions around variability, effect size and attrition in the available evidence and test their impact, so you can see where uncertainty remains.
Primary analyses are clearly defined in the SAP and kept separate from exploratory work, protecting the integrity of the evidence and making results easier to defend.
Data, analyses and documentation are structured so the path from protocol to conclusion stays clear, traceable and ready for regulatory review.
Biometrics is not one department within a wider model, it is the focus of our business. Sponsors work directly with experienced specialists who understand the study, the data and the decisions behind both.
Complex statistical methods should lead to clearer decisions, not harder conversations. We bring expertise across estimands, multiplicity, adaptive designs and sensitivity analyses, and explain what they mean in practical terms for study teams, leadership and regulators.
Our statistical work is separate from trial operations, giving sponsors an independent view when objectivity matters most. This is particularly valuable for interim analyses, IDMC support and second opinions on late-phase study design.
We structure data, analyses and documentation with submission requirements in mind from the outset. CDISC expertise and integrated medical writing help keep the evidence consistent, traceable and ready for review without unnecessary rework later.
We can lead full biometrics delivery, work alongside your existing CRO or support a defined workstream. Our model fits around the programme you already have, giving you the expertise you need without adding unnecessary complexity.
When a study is already under pressure, we bring an experienced, objective view. From inherited datasets and delayed analyses to statistical approaches that need reassessing, we help establish what can be resolved and what needs to change next.
Sometimes the hardest part is knowing where to begin. Our senior consultants help you clarify priorities, weigh development challenges, and find the right path forward across study design, statistics, regulatory strategy and data.
Explore consulting services
