Research within the rare diseases space brings its own set of challenges associated with clinical care, regulatory compliance, and commercial activities within the clinical trials environment. Managing each of these realms requires a deep knowledge of the disease state, the development space, and what data and evidence the regulatory authorities and payers will demand.
The global landscape for medical technology, biotechnology, and life sciences is on the cusp of seismic change. The confluence of geopolitical tensions, economic uncertainty, and evolving social values has created a complex web of challenges and opportunities for these sectors around the world.
Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework, including U.S. legislation broadening the scope of diversity consideration in clinical trials. In an article for the forthcoming August issue of ACRP’s Clinical Researcher journal, Faith Holmes, MD, Chief Medical Officer, and Kristen Snipes, CCRA, Executive Director, Project Delivery, both with Elligo Health Research®, examine how, despite this increased awareness and regulatory push, many long-standing challenges persist.
Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success. However, despite their frequent association, these terms embody distinct philosophies and practices.