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.
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
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 specialized partner, we meet you where you are to build a design that works for you.
What we do at this stage
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 risks not having a design formidable enough to withstand the submission.
The sponsors who avoid this outcome are the ones who invest in a rigorous statistical strategy before the first site is activated.
Starting a Trial
The decisions you make before enrolling the first subject define everything that follows.
Running a Study
Enrollment is just the beginning. Keeping it on track is where the real work starts.
Breaking New Ground
There's no predicate to reference.
Stuck or In Trouble
If you’re on this page, something has gone wrong, and you need help. Let's fix it.
Preparing to Submit
Your data is in. What happens next determines whether it's enough.
WHAT CLIENTS SAY
“They listen the first time. I’ve never had to go back and respell out what I needed."
”They work to understand the problem and leverage the information that is already there.”
Former FDA Regulator
WHAT CLIENTS SAY
"Battle ground tested."
"There is nothing that David and team haven’t seen over the years – the good, bad, and ugly.”
Vice President, Clinical Operations
WHAT CLIENTS SAY
"Get stuff done when you have to do something no one else has done before."
"They aren’t afraid to tackle difficult scenarios in compressed timelines."
CEO, Medical Device Company
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