Study Design

Clinical Research: Phase 1 - Phase 4

The 7 Most Important Steps for Success in Neurodegenerative Disease Trial Design

When it comes to clinical trials for neurodegenerative disease (NDD), it’s easy to get overwhelmed by complexity. Not only are the mechanisms that underlie NDDs like multiple sclerosis and Alzheimer’s still largely a mystery, their inherent variability is hard to account for. The best way to combat the problem? Break trial design down into more manageable pieces....

Clinical Research: Phase 1 - Phase 4

What Does Brexit Mean for Drug Development in the U.K.?

Britain’s plans to leave the European Union could profoundly affect clinical drug research in the U.K. The impact spans a broad range of unknowns, from where the London-based EMA will put down roots to Brexit’s influence on trial regulations, cost, funding, and recruiting of scientific talent. Our Chief Medical Officer, Dr. Colin Hayward, addressed these...

Clinical Research: Phase 1 - Phase 4

Getting It Right from the Start: Applying QbD to Rare Disease Studies

Quality and effective risk management are vital to every clinical trial, and their importance is greater still when working in rare indications. Your patient population is small, vulnerable, and geographically dispersed, so there’s limited data and little opportunity to replicate clinical trial results. It’s as if the phrase “get it right the first time” had...

Clinical Research: Phase 1 - Phase 4

Working with a CRO

The challenges of greater regulatory scrutiny, complex logistics, downward cost pressure and increasingly rigorous data requirements are just a few of the reasons biotech and pharmaceutical companies look to outsource clinical trials. In a dynamic healthcare and regulatory environment, outsourcing increases flexibility by streamlining clinical trial management and enabling sponsors to concentrate their resources on...

Study Design

Adaptive Design: Premier Research Participates in a Talk on Benefits, Risks, and Ethics

DURHAM, N.C., May 13, 2016 — A potent mix of benefits, risks, and ethical questions confronts researchers conducting novel adaptive design clinical trials. Dr. Thomas Laage, Senior Medical Director, Premier Research, explored this complex challenge in a webinar with members of the DIA Adaptive Design Scientific Working Group. Dr. Laage, with several co-authors of the...

Clinical Research: Phase 1 - Phase 4

Rare Oncology Research in the 21st Century

Speakers: Sachin KulkarniExecutive Director, Strategic Development, Oncology & General MedicinePremier Research Juliet M. MoritzExecutive Director, Strategic Development, Rare DiseasesPremier Research Study of rare cancers tends to look more like rare disease research than standard oncology research. This webinar will highlight some of the challenges in designing and conducting trials for rare cancers and explore positions...

Data Management & Biostatistics

The Ethical Challenges of Adaptive Design: Join a Premier Research Webinar Nov. 19

PHILADELPHIA, November 10, 2015 — What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out Thursday, Nov. 19, at a complimentary Premier Research webinar, Ethical Considerations in Adaptive Design Clinical Trials. The hour-long event, starting at 11 a.m. EST / 4 p.m. BST / 5 p.m. CET, will examine particular...

Clinical Research: Phase 1 - Phase 4

Rare Disease Trials: The Beginning, the Middle and the End

Speaker: Angi Robinson, Executive Director, Pediatrics and Rare Diseases, Premier Research This session includes a regulatory overview of rare diseases and orphan drug status as well as practical considerations for varying stages of the development process. Viewers will learn more about conducting successful Natural History studies and the presenters will review how to avoid common...