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...
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...
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...
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...
What happens when a widely recognized advance in clinical trial design poses ethical questions? Find out in this Premier Research webinar, Ethical Considerations in Adaptive Design Clinical Trials. The webinar will examine particular design adaptations and discuss the ethical obstacles they present — and potentially resolve. Jennifer Nezzer, Director of Biostatistics, and Dr. Thomas Laage,...
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...