We've seen it before. We know how to move.
BSC® has spent nearly four decades working on programs that didn't go according to plan. We've responded to FDA deficiency letters, rescued analyses from statistical errors, rebuilt submission packages under impossible timelines, and untangled the kind of data and documentation problems for years.
When you bring BSC in on a troubled program, the first thing we do is tell you the truth, about what the situation actually is, what's salvageable, what your options are, and what it will take to move forward. No false reassurance. No overpromising. Just clear, experienced judgment from people who have navigated worse.
Common situations we step into
FDA deficiency letter or Additional Information request — We assess the questions, evaluate your existing analyses, and develop a response strategy that is scientifically sound and directly responsive to what FDA is asking
Failed submission or Complete Response — We conduct a thorough review of what was submitted, identify the statistical vulnerabilities, and develop a remediation plan
Previous statistician dropped the ball — We audit existing work, identify gaps and errors, and rebuild what needs to be rebuilt — cleanly, thoroughly, and with full documentation
Tight deadline, no margin for error — We staff up, prioritize ruthlessly, and deliver — without cutting corners on quality or regulatory defensibility
What we do in these engagements
Drawing on our Analyze and Advance services, we support:
Rapid assessment and situation analysis
FDA deficiency response development
Statistical audit of prior work
Rescue analysis and alternative analytical frameworks
Emergency programming and TLF regeneration
Submission package remediation
Direct regulatory strategy support
This is not the time for the wrong partner
When a program is in trouble, the instinct is to move fast. That's right, and we agree. But moving fast with the wrong team makes things worse. FDA responses require precision. Rescue analyses require defensibility. Rebuilt submission packages require the kind of rigor that holds up.
BSC® delivers speed without sacrificing the quality that regulatory submissions demand. We've done it before. We'll do it for you.
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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