Author: Jennifer Dennis-Wall, PhD

Rare Disease Awareness

Commonalities of Rare Diseases

Collectively, rare diseases affect a huge number of people: about 25 million in the US and 400 million globally. To qualify as a rare disease per the US standard, fewer than 200,000 Americans must be affected by the condition, or per the EU standard, fewer than 1 in 2000 Europeans …

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Governing Body

New FDA Guidance for NASH Drug Development

Just in time for our final follow-up to the two previous articles on non-alcoholic steatohepatitis (NASH), the FDA released a new draft guidance for drugs being developed to treat the disease. In this blog, we present a couple of highlights from the guidance.   The new draft guidance very heavily …

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Pediatric Diabetes

The Future of Diabetes Treatment

Type 1 diabetes affects millions of people in the US alone. What’s worse is that the majority of patients do not achieve good control of their blood glucose levels. Management of type 1 diabetes has traditionally been cumbersome, time-consuming, and expensive, so better treatment methods are sorely needed.   For …

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Lab

A Deep Dive into NASH Physiology and Drug Targets

In the clinical trial world, we spend a lot of time focusing on phase I-IV trials, and it’s easy to forget about the very important preclinical, basic science studies that go into drug development.   Many pharmaceuticals are developed from basic science studies, or studies that attempt to define molecular …

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Teamwork2

How Managers Can Establish Good Working Relationships with their Internal Team

Authors: Geetesh Shrivastava, Associate Director of Clinical Monitoring; Jennifer Dennis-Wall, PhD, Lead Scientific Writer Back in August, we published a blog addressing themes that are important for sponsor partners to follow so that we as a CRO can provide them with the best possible service. To complement those themes, we …

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Site

Considerations for Working with Research-Naive vs. Experienced Sites

When recruiting patients with hard-to-enroll indications, such as rare diseases, it is sometimes necessary to dip into creative resources for finding sites. Sometimes this means looking across the ocean, or sometimes there may be opportunities in your backyard. Some sites have a lot of experience, and those are generally sought …

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Liver

Why Aren’t There Any FDA-Approved Drugs to Treat NASH?

The liver does many important things in the body, such as filtering of the blood and metabolizing all compounds, including food and drugs, that enter the body. In that vein, liver disease can be absolutely devastating.   Non-alcoholic fatty liver disease (NAFLD) affects almost 100 million, or around 25%, of …

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Eye

You’re Holding Your Eye Drops Wrong – What Makes Ophthalmology Trials so Challenging?

Last week, one of our resident experts in ophthalmology, Ignacio Handal, gave a training for some of our current studies with a focus on which pitfalls to avoid specifically in ophthalmology trials. He dished out many fun facts and eye-opening insights.   Compliance is difficult enough to achieve for any …

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Breast Cancer Awareness

A More Complete Scope for Advances in Women’s Health

When people think about women’s health, especially during the month of October, they may think only of breast cancer or reproductive disorders. The truth, though, is that women’s health encompasses so much more. The field of medicine pertaining to women’s health is rapidly growing to include the study of both …

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Gears

The Politics of Investigator-Initiated Trials

Many clinical trials are initiated by a pharmaceutical company in order to generate data to submit to the FDA for drug approval. Investigator-initiated trials (IITs), on the other hand, are conceived by a clinician and not by the company that plans to sell the drug or device under study. IITs …

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AdobeStock_213934977

Six Things We Can Do Now to Advance Clinical Research in CKD

“What we need to do is to keep working on getting biomarkers more defined to be able to differentiate between the different etiologies. This is going to be the path forward.” Chronic kidney disease (CKD) is actually 20 times more prevalent and 100 times more lethal than cancer, but it …

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Womens-Health-Blog-Image

The Tumultuous History of Women’s Involvement in Clinical Research

Inclusion of women in clinical research has a surprisingly colorful history. As you can probably imagine, inequality is present throughout, but for reasons that may not be so intuitive.   If you haven’t heard of the thalidomide crisis, here is a brief synopsis. In 1957, thalidomide was put on the …

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