This guide outlines the components you should consider for designing Phase 2 protocols with marketing approval in mind. Phase 2 is a critical make-or-break stage of product development. All too […]
This white paper examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s […]
You may be familiar with Right-to-Try, but what does it actually mean for product sponsors? This white paper explores both Right-to-Try legislation and existing Expanded Access Programs, including: Understanding sponsor […]
Far too often clinical development programs fail, even when a drug or device likely had a favorable effect on disease outcome. There is considerable need for increased recognition of the […]
In this white paper, “To SPA or Not to SPA: That is the Question. Understanding Special Protocol Assessments,” David Shoemaker, SVP of Research and Development at Rho, provides strategic recommendations […]
A protocol is the most important document in a clinical study as it is the foundation for subsequent operational, regulatory, and marketing objectives for the development program. Developing a protocol […]
Many trials, particularly those for treatments of psychiatric disorders or pain, involve the use of human raters. This article looks at how human raters can contribute to apparently high placebo […]
The FDA’s Accelerated Approval, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations were created to help speed up the approval of drugs and biologics that effectively […]
