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Clinical Development

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Could Your Drug Development Program Benefit from an NDA/BLA/PMA Gap Analysis?

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Whether you plan to file a new drug application (NDA), a biologics license application (BLA), or a premarket approval application (PMA) with the FDA or a marketing authorization application (MAA) with the European Medicines Agency, you’ll need an in depth understanding of how the data you have from your clinical studies, nonclinical studies, and Chemistry, Manufacturing and Controls (CMC) / Quality development map to the requirements of the application.

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How much does a clinical trial cost? Understanding the 8 major factors driving CRO bids

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“How much does a clinical trial cost?” This is a question we frequently get in some form from Sponsors in early phases of development that are trying to figure out what it will cost to hire a CRO to conduct their clinical trials and associated regulatory activities. While the high degree in variability between trials would make it difficult to provide a single answer, we can explain what factors can drive costs up or down.

Genna Kingon
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10-Step Commercial Clinical Protocol Authoring Guide

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Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success.  The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.

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Practical Strategies to Simplify Patient Centricity: Part 3—Why Patient Centricity, Why Now?

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This is the third in a series of blog posts on putting patient-centric principles into practice. Before diving into the practical ramifications of patient centricity, it helps to understand some of the factors responsible for the emergence of this trend. In this post, we examine a few of the driving forces behind patient centricity, and consider consequences for our industry.

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Practical Strategies to Simplify Patient Centricity: Part 2—Patient Stories & the Importance of Communication

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This is the second in a series of blog posts on putting patient-centric principles into practice. Excellent retention practices, such as those shared in the first article in this series, are a great first step but before we implement them and call it a day, we need to ask ourselves, why are we doing this? Our motivations tend to guide our actions and communications.

patient-centricity-elephant
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Practical Strategies to Simplify Patient Centricity: Part 1—Overview

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This is the first in a series of blog posts on putting patient-centric principles into practice. How do you eat an elephant?  One bite at a time, right? Specifically, how do we eat the elephant of patient centricity?  We can employ simple, actionable, “bite-sized” strategies that will move us closer to a more patient-centric approach.

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