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10-Step Clinical Study Protocol Authoring Guide

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 […]

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Case Study
Rho and Anthera Pharmaceuticals’ Collaborative Partnership in Cystic Fibrosis

Over a three year period, Rho and Anthera Pharmaceuticals developed a collaborative partnership developing a product to treat Cystic Fibrosis. Some highlights of the partnership included: Expanding the scope of […]

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Article
Choosing the Appropriate NDA – How Complex Drugs Fit In

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Article
Age Diversity in Clinical Trials: Addressing the Unmet Need

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Article
Craftsmanship in Clinical Study Design

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Article
Working in Vulnerable Patient Populations: Research in the Cognitively Impaired

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When Placebo Response Isn’t Placebo Response: The Perils of Human Raters

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 […]

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Article
Late-Stage Biostatistics Submissions Services

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Blog
Trends in Clinical Trial Participation of Approved Drugs by Sex and Race: 2015 to 2019

Diversity in clinical research is important for ethical and scientific reasons. When women and non-White populations are not represented in clinical research, this limits our understanding of the safety and efficacy of drugs to treat important health issues in these populations. Learn more about these findings in Yael Symes’ comprehensive blog.

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Article
5 Red Flags Your CRO is Putting Your Clinical Trial at Risk

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