Running a Study
We stabilize, support, and advance trials in motion.
BSC® works with sponsors at every stage of an active trial — whether you've had a statistician from day one and need specialized support, you're inheriting a study that needs fresh eyes, or you're realizing for the first time that you need a statistical partner. We integrate quickly, assess what's working, and provide the expertise needed to keep your trial on track.
Mid-trial, the stakes are high, and the margin for error is narrow. We bring the experience and composure to navigate that environment without disrupting momentum.
What we do at this stage
Drawing on our Analyze and Design services, we support:
Interim analyses — Pre-specified and unplanned interim reviews, DSMB/IDMC packages, stopping rule evaluation, and posterior probability assessments
Data quality — Identifying and resolving data inconsistencies across sites, reconciling incoming datasets, developing data screening and cleaning protocols
Enrollment support — Statistical assessment of enrollment trends, simulation modeling for revised timelines, sample size re-estimation where pre-specified
Protocol amendments — Statistical justification for mid-trial changes, impact assessments on power and analysis populations
Ongoing statistical oversight — Blinded data review, safety monitoring support, and real-time analytical consultation
The mid-trial window is narrow
A data quality issue that goes unaddressed can compound across sites and visits. An enrollment shortfall that isn't assessed statistically can become a power problem at analysis. An interim analysis conducted without the right expertise creates regulatory exposure that's hard to walk back.
The sponsors who navigate active trials successfully often are the ones who treat statistical support as an ongoing partnership throughout.
Wherever you are in your trial, we can meet you there.
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