Oncology
Cancer device trials demand sophisticated survival analyses and compelling benefit-risk narratives. BSC®'s regulatory experience helps you build the evidence strategy FDA expects, positioning your device for approval in this challenging therapeutic area.
Overview
BSC® supports oncology clinical trials for both therapeutics and devices, including surgical oncology devices, radiation therapy systems, diagnostic technologies, and supportive care devices. Our experience spans solid tumors and hematologic malignancies.
Specialized Capabilities
Overall survival and progression-free survival endpoint design. Adaptive designs for dose-finding and seamless Phase II/III trials. Response evaluation criteria (RECIST, iRECIST) implementation. Competing risks analysis for oncology outcomes. Propensity score methods for real-world evidence studies.
Regulatory Experience
We understand oncology division expectations for time-to-event endpoints, interim analysis strategies, and appropriate alpha-spending approaches. Our team has experience with accelerated approval pathways, breakthrough therapy designations, and surrogate endpoint justification.
Representative Studies
Surgical oncology devices (ablation, resection).
Radiation therapy planning and delivery systems.
Cancer diagnostic and monitoring devices.
Supportive care technologies (pain management, symptom control).
Minimal residual disease detection systems.
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