Explore Article
Find what matters to you
Overcoming the Complex Challenges in Schizophrenia Trials
Schizophrenia is a disabling, lifelong disease that is difficult to diagnose and treat due to its complexities and challenges. These same intricacies and complications are a critical part of clinical trial development that require a deep understanding of the disease and how to mitigate the anticipated challenges during trial design necessary to advance treatment without delaying study timelines. we discuss how to overcome three of the most complex challenges of any Schizophrenia trial:
Assessments and Scales. Raters and Site Management, and Recruitment and Retention.
From Trial Concept to Final Site List: Leveraging Clinical Data Platforms for a Tailored Trial Strategy
From the continuous development of clinical trial and data platforms to the ever-increasing complexity of therapeutic landscapes, understanding the best approach towards conducting feasibility for a clinical trial can prove daunting. Through our expertise in the most innovative feasibility tools and data platforms, we combine these data sources with our operational experience to put forth the most comprehensive, data-driven approaches to starting clinical studies off on the right foot.
Clinical Studies Required for a 505(b)(2) Development Program
A very common yet very critical question for a 505(b)(2) development program is “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program.