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Author Archives: Jacquie Powell

What is the Clinical Outcome Assessment Qualification Process?

May 13, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Clinical Outcome Assessments (COAs) can be qualified through the COA Qualification Program, one of the Drug Development Tools (DDT) Qualification Programs developed by the Center for Drug Evaluation and Research (CDER) at the FDA.

In a previous post, we discussed that COAs currently under development, as well as those relied upon in recent drug approvals, have been included in the pilot COA compendium. In this post, we will discuss the COA Qualification Program – stay tuned for an upcoming post on the Biomarker Qualification Program, as well.

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FDA’s Pilot Clinical Outcome Assessment Compendium – A Valuable Drug‑Development Resource

April 28, 2016 | Jacquie Powell, PhD, Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

The three R’s (reduce, reuse, and recycle) typically conjure up ideas about conserving natural resources but they are also a great illustration for how FDA’s newly-available pilot clinical outcome assessment (COA) compendium can increase the efficiency of the drug-development process.

By collating and summarizing COAs across many different disease states and indications, the publically-available COA compendium should allow drug developers to reduce the amount of time spent on the development of new COAs, reuse existing COAs as appropriate, and potentially recycle elements of existing COAs to create meaningful measures in clinical areas where no COAs currently exist.

But maybe we should take a step back and start at the beginning…


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8 Easy Steps to Establish an Electronic Submissions Gateway (ESG) Account with the FDA

April 16, 2015 | Jacquie Powell, PhD, Clinical Research Scientist | Regulatory Operations

In a previous post, we outlined the upcoming requirements for electronic submissions. In this post, we’ll show you how to set up an account for submitting regulatory documents electronically via the FDA’s Electronic Submissions Gateway (ESG, aka the Gateway).

What is the Gateway?
The ESG is a portal that facilitates communication between the FDA and the pharmaceutical industry by providing a secure digital environment to submit regulatory documents for review.

The ESG can either be accessed through the internet, using the WebTrader interface, or via an AS2 Gateway‑to‑Gateway connection. Many small to midsized companies find the WebTrader system preferable because it uses a standard internet browser and is relatively inexpensive, while larger companies often use the Gateway-to-Gateway connection.

How to access the ESG through WebTrader is the focus of this post but more information about setting up an AS2 Gateway‑to‑Gateway connection can be found here.

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