
Partnering with Patients to Develop Meaningful Endpoints – Practical Considerations
Selection of appropriate endpoints for rare disease clinical studies can be challenging but is critical to assessing the efficacy of new medicines.…
In light of JIA Awareness Month, its treatments, its stigma, and more, we spoke with Dr. Johnny Peppers, Executive Director of Drug Development for…
Over the past several months, participants in PRA Health Sciences’ Health Harmony COVID-19 Monitoring Program have had vital information about…
Selection of appropriate endpoints for rare disease clinical studies can be challenging but is critical to assessing the efficacy of new medicines.…
This white paper provides biotech companies an overview of the considerations for Chemistry, Manufacturing and Controls (CMC) in asset development.…
A single product candidate that provides clinical benefit across multiple indications and patient populations allows more conditions to be treated…
Clinical drug development is moving away from traditional approaches that rely on rare disease patients to travel long distances to clinical sites…
The current drug development research paradigm is flawed in that it fails to include a diverse and representative patient population. A new approach…
This whitepaper offers a high-level orientation around the key barriers to readiness and critical success factors for companies navigating the…
Emerging biotech companies are a significant and burgeoning sector of the pharmaceutical development market. These companies may require unique and…
Clinical trial transparency has emerged in recent years as a key function within pharmaceutical and academic organizations. Although trial…
Plain language summaries (PLS), also known as lay summaries and trial results summaries, educate participants and the public about clinical trial…
Clinical Trial Disclosure (CTD) is a compliance requirement mandated by various national laws and policies, and is at the heart of a paradigm shift…