Data Management & Biostatistics

Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies

Risk-Based Monitoring (RBM) makes an impact. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...

Data Management & Biostatistics

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results.  As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive...

Patient and Stakeholder Engagement

Premier Insight 270: A Rosacea Trial Failed Many Enrollment Hurdles.

Two large, parallel trials with 107 sites spread across the United States. Heavy competition for patients because of multiple competing treatments already on the market. And an advertising strategy that needed to attract more than 1,400 subjects fast enough to meet the sponsor’s aggressive schedule. Those were just some of the challenges we faced when...

Medical Device and Dermatology Experts Presenting at MAGI East Conference

DURHAM, N.C., May 3, 2019 — Two of our top experts, Joanne Emmett, Vice President of Clinical Development Services for Medical Device and Diagnostics, and Jasmina Jankicevic, MD, MSc, CCRP, Dermatologist, Executive Director, Medical Affairs, will participate in three sessions at the MAGI 2019 East Clinical Research Conference in Boston. Emmett, head of medical devices,...

Clinical Research: Phase 1 - Phase 4

Understanding Recent Updates to the Classification of Rosacea

Since 2002, doctors and researchers have used a standard rosacea classification system to provide consistent terminology as well as to facilitate studies, clinical diagnosis, and treatment. However, in 2018, the Journal of the American Academy of Dermatology published a new standard classification system that replaces the previous one[1]. Below is some of the most important...

Consulting

Current Rosacea Treatment Algorithms: Guide to Subtypes and Existing Therapies

Rosacea is a common condition occurring on the convexities of the face and affecting middle-aged persons. It may be caused or worsened by a variety of different factors, including genetics; problems with the blood vessels in the face, the nervous system, and/or the immune system; the presence of Demodex mites; and environmental factors. It is...

Clinical Research: Phase 1 - Phase 4

From Psoriasis to Behçet’s: The Evolution of Biologics in Dermatology

Over the last two decades, biologics have improved the management of patients with psoriasis and advanced melanoma, many of whom either did not respond to traditional treatments or experienced severe side effects from them. With their success in deadly forms of melanoma and more common chronic inflammatory conditions such as psoriasis, drug developers are now targeting rarer...

Applied Clinical Trials – Improved Understanding of Psoriasis Buoys Treatment Hopes for Patients

Of all the stunning advances medical science has made over the past few decades, perhaps few are more pronounced than the treatment of psoriasis. In the 1950s, common remedies included arsenic, ammoniated mercury, and coal tar. In the ‘60s and ‘70s, heavy advertising promoted a “new healing discovery” called Tegrin, a coal tar product promising...

Clinical Research: Phase 1 - Phase 4

Four Things You Need to Know About mHealth and the Dermatology Field

Advances in medical technology have opened the door for dermatology mobile health (mHealth) programs, and these same technologies have the potential to radically change dermatology trial designs. Here are four ways digital disruption in the dermatology field is benefiting both patients and providers: 1. Reduced wait times: Digital health assessments make time spent scheduling, traveling,...

Clinical Research: Phase 1 - Phase 4

3 Strategies for Treating Psoriasis

We’ve previously discussed several issues around psoriasis, including the pathogenesis of the condition and the challenges (and solutions!) of conducting psoriasis clinical trials. Today we turn toward three strategies for treating it. Although moisturizer may be an effective solution for some cases of mild psoriasis, many patients require medical intervention to ease their symptoms and...