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BSC® Knowledge Base

In-Depth Insights Gathered Over Four Decades.

September 18, 2026

10 Medium-Sized CROs in North America

Industry Landscape

September 18, 2026

Non-Inferiority (NI) Trial Design and Strategy

Trial Design & Methodology

September 18, 2026

Why are inclusion criteria important?

Trial Design & Methodology

September 18, 2026

Receiving an FDA AINN Letter

FDA Regulatory Strategy

September 18, 2026

Private Equity Bought Your Sponsor.

Industry Landscape

September 18, 2026

What Is the EMA?

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September 18, 2026

CROs & Venture Capital: Accelerating Biotech Innovation

Industry Landscape

September 18, 2026

Clinical Data Presentations for Orthopedic Device Applications

FDA Regulatory Strategy

September 18, 2026

What is a DSMB?

Trial Design & Methodology

September 18, 2026

The Endpoint Hierarchy: Primary vs Secondary vs Exploratory

Trial Design & Methodology

September 18, 2026

The 10 Largest Clinical Research Organizations (CROs)

Industry Landscape

September 18, 2026

To Be or Not To Be Covariate Adjusted

Trial Design & Methodology

September 18, 2026

Beyond the Code

Data & Statistical Methods

September 18, 2026

The Role of DMCs

Trial Design & Methodology

September 18, 2026

A Comprehensive Overview of CDISC

Data & Statistical Methods

September 18, 2026

What is a Composite Endpoint?

Trial Design & Methodology

September 18, 2026

Overview of Building 66

Industry Landscape

September 24, 2026

E9 Statistical Principles for Clinical Trials

Trial Design & Methodology

September 24, 2026

E9(R1) Addendum: Estimands & Sensitivity Analysis

Trial Design & Methodology

September 24, 2026

Multiple Endpoints: Why Manufacturers Can't Ignore Multiplicity

Trial Design & Methodology

September 24, 2026

The Critical Role of Radiographic Data in Device Clinical Trials

Trial Design & Methodology

September 24, 2026

In Silico Trials: Transforming Medical Device Development

FDA Regulatory Strategy

September 24, 2026

Beyond the Data: The Strategic Role of COAs

Trial Design & Methodology

September 24, 2026

Understanding the Content of Premarket Submissions

FDA Regulatory Strategy

September 24, 2026

FDA Breakthrough Device Designation

FDA Regulatory Strategy

September 24, 2026

FDA Q-Submission Program 2025

FDA Regulatory Strategy

September 24, 2026

Randomization and Kit Lists

Trial Design & Methodology

September 24, 2026

The Strategic Edge in FDA Submissions

FDA Regulatory Strategy

September 24, 2026

Understanding Medical Device Regulation Compliance

FDA Regulatory Strategy

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Former FDA Regulator

WHAT CLIENTS SAY

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Vice President, Clinical Operations

WHAT CLIENTS SAY

"Get stuff done when you have to do something no one else has done before."


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CEO, Medical Device Company

BSC® Differentiator

What Sets us Apart

Submission Grade Experience

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.

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