Design.
From concept to strategy, we design regulatory-ready trials that align with FDA expectations and accelerate timelines.
Our expertise ensures every protocol, endpoint, and analysis plan is rooted in statistical rigor and clinical relevance.
Scientific Rigor.
We bring robust, reproducible science to every study we design.
Our statisticians work on the cutting edge of clinical trial design, apply modern statistical principles, leverage historical data where appropriate, and tailor analyses to the clinical questions that matter most.
From traditional RCTs (randomized controlled trials) to novel adaptive designs, our approach ensures sufficient power, control of Type I error, and sensitivity to real-world effects.
The result: statistical sound and transparent designs that are fully defendable under peer review or regulatory scrutiny.
Regulatory Expectations.
Regulatory alignment starts on day one. We design trials that anticipate what regulators will ask, informed by current FDA guidance, recent decisions, and our deep experience supporting Pre-Subs, IDEs, PMAs, and NDAs.
Our team helps sponsors mitigate risk by designing protocols that are defensible, efficient, and clearly mapped to key stakeholders. By shaping strategy early, we help you avoid costly redesigns and stay on the fastest path to regulatory success.
The result: Fewer regulatory surprises, streamlined review processes, and trials designed to meet FDA expectations.
Operational Feasibility.
A Trial that can’t be executed is a trial that can’t succeed. We embed operational realities into every design decision—from enrollment rates and site readiness to visit schedules and data collection burden. Trials should be designed informed by site behavior, historical benchmarks. Simulation modeling can help ensure feasibility from day one.
The result: fewer surprises, faster enrollment, and trials that stay on timeline and budget, without compromising scientific integrity.
Database Design
CRF Review
Design database/data flow infrastructure
Specify entry procedures
Set data handling guidelines
Write data screening plan
Other data management plan tasks
Study Design
Design, develop, or specify statistical methods for the study
Sample size and statistical power analyses
Set Statistical guidelines or ground rules for the study
Create Mock Tables, Reports, or Figures
Writing of the Analysis Plan text
Other data analysis plan tasks
Specialized Design
Adaptive Design
Propensity Score Matching
Simulation studies
Historical Control Strategies
Why do we focus on these core services?
Each of our core services is designed to proactively de-risk and advance clinical development. Rather than reacting to data or regulatory feedback late in the process, we shape the trial from the start to:
Reduce ambiguity in execution by documenting clear statistical logic and expectations.
Strengthen regulatory confidence with methods that are transparent, reproducible, and aligned with current FDA guidance.
Accelerate timelines through efficiencies in sample size, design adaptations, and pre-specified decision points.
Minimize downstream surprises, such as post-hoc justifications, unclear endpoints, or avoidable amendments.
Enable cross-functional clarity, giving project teams, CROs, DSMBs, and sponsors a shared understanding of how the trial is designed and will be evaluated.
The result: designs that work in the real world, not just on paper.
Case Studies.
Case Study #1:
Spinal Fusion — Aligning Scientific Rigor with PMA Requirements
A device company developing a novel spinal fusion system needed to meet stringent FDA criteria for a PMA submission. We collaborated early to design a composite primary endpoint that captured both radiographic and clinical success, while developing an adaptive design that allowed for potential sample size re-estimation. The design reduced trial risk while remaining fully aligned with regulatory expectations.
