Clinical Research: Phase 1 - Phase 4

Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Speakers:Anne-Marie Nagy, Ph.D., Executive Director, Strategic Development, Neuroscience, Premier ResearchTodd Leathers, MBA, Executive Director, Strategic Development, Neuroscience, Premier Research Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis alone is tricky, given the often-delayed onset of symptoms, and optimizing study design, recruitment, event adjudication, and biomarker use complicates...

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...

The Powerful and Evolving Role of Patient Advocacy Groups in Clinical Research

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...

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...

Welcome to Premier Perspectives!

Thanks for visiting the newest addition to our website, our Premier Perspectives blog! Our goal? To give Premier People the chance to share and discuss their industry insights and ideas with customers, colleagues, patients, employees, and basically, anyone who’s interested in clinical research. We believe in improving productivity in clinical development, and sharing our ideas and best...

Premier Insight 265: Exceeding Expectations: Durable Remission in Diffuse Large B-Cell Lymphoma

When a developer of a CD19-directed cytolytic antibody for B-cell Lymphoma engaged Premier Research to assist with screening and enrollment in a global Phase 2 study, the Premier project team devised an operational strategy with a goal to exceed expectations. Despite several challenges, the enrollment was completed three months ahead of schedule thanks to consistent...

Premier Insight 258: Glioblastoma Drug Study Yields ‘Unexpectedly Huge’ Advance

A three-nation study of a treatment for recurring glioblastoma showed the therapy more than five times as effective as the typical protocol, an unexpectedly large advance in fighting these aggressive brain tumors. But it was a long road, and the drug’s efficacy was a big factor in extending the trial to five years — nearly...

Premier Insight 256: A Talent for Resolving Unusually Complex Issues

A customer came to us with a seven-year project to develop a novel human antibody from scratch, to treat multiple myeloma. There were no benchmarks, no relevant data on similar compounds because there were no similar compounds. The first challenge: engage key opinion leaders This project was never going to be easy or “by the...

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...