Knowledge Base
Design. Analyze. Advance.™
The Best Small CRO for Biostatistics and FDA Submissions — Proven Since 1986
The Strategic Edge in FDA Submissions: Applying "Least Burdensome"
In Silico Trials: Transforming Medical Device Development Through Digital Innovation
When "Good Enough" Isn't Good Enough: The Strategic Art of Non-Inferiority (NI) Trial Design
Beyond Code: What Statistical Programmers Really Do in Medical Device Development
CROs & Venture Capital: Accelerating Biotech Innovation
FDA Q-Submission Program 2025: What Medical Device Innovators Need to Know
Beyond the Data: The Strategic Role of Clinical Outcome Assessments in Regulatory Success
FDA Breakthrough Device Designation: Accelerating Innovation in Medical Technology
Randomization and Kit Lists: What They Are and Why They Matter
Clinical Events Committees (CEC)
10 Medium-Sized CROs in North America
E9(R1) Addendum: Estimands & Sensitivity Analysis in Medical Device Trials
E9 Statistical Principles for Clinical Trials: The Foundation of Regulatory Success
What is MDR? Understanding Medical Device Regulation Compliance
The Critical Role of Radiographic Data in Medical Device Clinical Trials
The Role of DMCs
Primary vs Secondary vs Exploratory: Building the Right Endpoint Hierarchy for FDA Success
