Biostatistics

Statistical Excellence: Solutions for Drug Development.

Inference at its core is a statistical company driven by expertise in consulting, development, analysis, and reporting. We do this deliberately, efficiently, and passionately —supporting studies from First-in-Human through Phase 3 trials with precision and insight.

Our team of experts partner with our clients throughout the process, delivering statistical solutions and high-quality deliverables that meet regulatory expectations.

From survival analyses to mixed models, Inference provides clear, informative statistical outputs that align with the clinical development objectives, enabling confident, data-driven decisions.

Our U.S. based Biostatisticians can provide support through flexible FSP or project-based models.

Services Include

Protocol Development:

Endpoint selection: Align endpoints that meet regulatory expectations and study objectives.
Sample size: Calculate the appropriate sample size to achieve adequate power.
Innovative Designs: Expertise in Bayesian/Adaptive study designs.

Analyses and Reporting:

SAP: Prepare Statistical Analysis Plans incorporating the latest methodological advancements that statisticians at the FDA and other regulatory agencies expect.
Analysis Specifications: Guide the statistical programming team with accurate programming specifications to align analyses with the SAP.

Data Monitoring Committees (DMC):

Prepare DMC charters, including early stopping rules for efficacy or futility
Serve as an independent entity managing all data for DMCs
Help the DMC members with ad hoc outputs as they are sought for making accurate interpretations of the interim data.

Regulatory Consulting and Submissions:

Represent sponsors at FDA, EMA, and other regulatory meetings.
Prepare all deliverables for an NDA/BLA.
Address data-related questions from regulators as the sponsor receives them during the NDA/BLA review process.

PARTNER WITH US

When you work with Inference, you gain a trusted partner with the experience, tools, and dedication to support your clinical development goals. Let us simplify the complexities of statistical programming and regulatory submissions so you can focus on delivering impactful therapeutic solutions. Connect with the Biostatistics team to discuss further.