The decisions you make before enrolling the first subject defines everything that follows.

Trial design isn’t just a statistical exercise. It's a regulatory commitment. The endpoints you choose, the sample size you calculate, the analysis plan you pre-specify — these decisions lock in your path to approval before a single subject is enrolled. Get them right, and everything downstream gets easier. Get them wrong, and no amount of brilliant analysis can fix them later.

The challenge is that most sponsors don’t know what they don't know. FDA expectations aren't always written down. The guidance documents leave room for interpretation. And the cost of a flawed design isn't visible until it's too late to change course.

That's where BSC® comes in.

We bring regulatory foresight to the design stage.

We've spent nearly four decades supporting FDA submissions across medical devices, diagnostics, and therapeutics. We know what reviewers look for, where designs tend to break down, and how to build trials that hold up under scrutiny — before the protocol is ever finalized.

Partnering with BSC® at the start of a trial means:

• Your endpoints are clinically meaningful and statistically defensible

• Your sample size is justified, powered appropriately, and tied to a realistic enrollment plan

• Your analysis plan anticipates FDA questions rather than reacting to them

• Your design reflects current agency guidance, not outdated precedent

• Your team has a clear, shared understanding of how the trial will be evaluated

Whether you’re a first-time sponsor navigating the process for the first time, an established company launching a new product line, or a CRO that needs a credible statistical partner, we meet you where you are and build a design that works.

What we do at this stage

Drawing on our Design services, we support:

• Protocol development and statistical input to study design

• Sample size and power analyses, including simulation-based approaches

• Endpoint selection and hierarchy development

• Statistical Analysis Plan (SAP) development

• Mock Tables, Listings, and Figures (TLFs)

• CRF review and data management planning

• Pre-Submission (Pre-Sub) meeting support and strategy

The cost of starting wrong

A trial that isn't designed with the FDA in mind doesn't fail at submission — it fails at design. By the time a deficiency letter arrives, the study is complete, the data is locked, and your options are limited. The sponsors who avoid this outcome are the ones who invest in a rigorous statistical strategy before the first site is activated.

Starting right isn't just good science. It's the most efficient path to approval.