Between locked data and a submission package that satisfies FDA reviewers lies a body of work that requires precision, experience, and an unflinching assessment of what your data actually shows.
We deliver submission-ready statistical packages that hold up under scrutiny.
BSC supports sponsors through the full arc of submission preparation — from final analysis and programming through CSR statistical sections and submission package QC. Whether you've been with us since the design stage or are bringing us in to carry the work across the finish line, we integrate seamlessly and deliver with the rigor FDA expects.
When the data isn't telling the story you expected
It happens more often than sponsors want to admit. The primary endpoint missed. A subgroup tells a more complicated story. The effect size is smaller than powered for. Before concluding the program is lost, experienced statistical eyes need to assess what the data actually supports.
BSC helps evaluate what the data can and cannot support, identifying defensible analytical approaches, assessing sensitivity analyses, and determining whether a credible path to submission exists. We find the strongest defensible story your data allows, and we tell it clearly.
What we do at this stage
Drawing on our Analyze and Advance services, we support:
- Full statistical analysis of primary, secondary, and exploratory endpoints
- Statistical programming, TLF generation, and QC
- CSR statistical methods and results sections
- Sensitivity analyses and alternative analytical frameworks
- Response to FDA statistical questions post-submission
- Integrated summary support and appendix development
- Submission package review and de-risking assessment
The cost of an imperfect submission package
A statistically sound trial can still produce a flawed submission. Poorly documented methods, inconsistent TLFs, unsupported conclusions, or analyses that don't align with the pre-specified SAP.
All of these invite FDA questions that delay approval and erode reviewer confidence. When so much has been invested in the trial, why increase the odds of submitting a flawed submission?
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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