Diabetes & Endocrinology
We support continuous glucose monitors, insulin delivery systems, and metabolic devices through FDA's evolving regulatory landscape. BSC's comparative effectiveness expertise and real-world evidence capabilities position your device for both regulatory approval and market differentiation.
Overview
BSC supports the development of diabetes management technologies, continuous glucose monitoring systems, insulin delivery devices, and other treatments for endocrine disorders. Our expertise spans type 1 and type 2 diabetes, as well as metabolic and hormonal conditions.
Specialized Capabilities
HbA1c analysis and glycemic control endpoint design. Time-in-range analyses for CGM data. Hypoglycemia event adjudication and severity assessment. Closed-loop insulin delivery system statistical design. Long-term diabetes complication modeling.
Regulatory Experience
We understand unique FDA expectations for diabetes devices, including appropriate non-inferiority margins for glucose control, safety assessments of hypoglycemia risk, and integration of patient-reported outcomes. Our team has experience with both ambulatory glucose profile analysis and traditional HbA1c endpoints.
Representative Studies
Continuous glucose monitoring systems.
Insulin pumps and closed-loop systems.
Diabetes management software and algorithms.
Glucose meters and point-of-care testing.
Metabolic disorder treatment devices.
Regulatory-first biostatistics
Support built specifically for FDA-facing programs, from early feasibility through submission and post-market requirements.
Direct communication, faster turn around
Our biostatisticians write the SAP and run the analysis. One person owns both — no separate programmer, no project manager in between.
Versatile Solutions
Engage us for a focused analysis or a full submission, We size the work to the problem.
Proven FDA Experience
Hands-On Experience with FDA Pathways, statistical reviews, and regular interactions, reducing risk and rework.
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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