Study Start-Up

Project Management

Come Together: The Foundational Team for your Heart Valve Study

An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study. You build that foundation with your...

Consulting

Heart Valve Studies: 6 key players required for success

As market demand for AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) has exploded, companies face increasing pressure to rapidly deliver actionable clinical trial data. The key to success lies in the team. And the foundation of an effective team begins by understanding each role—and, where applicable, how to best select each...

Clinical Research: Phase 1 - Phase 4

Against the Odds: Achieving Fast Startup in a Sickle Cell Drug Trial

Even when things go pretty well, launching a clinical trial is a game of long odds. And when the deck is stacked against you the way it was when we set out to study a drug for sickle cell disease, the difficulties can add up fast. So even we were surprised by the success of...

Data Management & Biostatistics

Premier Research Joins TriNetX Global Health Research Network to Access Real-Time Site & Patient Metrics

DURHAM, N.C., JULY 21, 2017 — Premier Research, seeking to accelerate clinical trial design and patient recruitment to better serve its highly innovative customers, has signed an agreement with TriNetX to allow direct query access to its global health research network, comprised of healthcare organizations representing over 84 million patients globally. The Durham-based contract research organization will use TriNetX’s cloud-based platform...

Consulting

Rushing Site Selection in Fibromyalgia Trials, Not a Great Idea

In the early days of fibromyalgia drug research, trial site selection centered almost exclusively on rheumatologists and pain centers. But with more drugs on the market and still more studies underway, there has been significant expansion in the number of sites equipped to conduct this research. Up to a point, anyway. As fibromyalgia therapy matures,...

Clinical Research: Phase 1 - Phase 4

Strategies for Finding ‘Hidden’ Patient Populations

A little less than five percent of the world’s population are estimated to suffer from more than 7,000 different types of known rare diseases. There are even more medical conditions where those who have them are too embarrassed to talk about what’s wrong or simply don’t know exactly what ails them. Yet, these individuals are...

Clinical Research: Phase 1 - Phase 4

Want to Study Rare Disease? Get Ready for These Roadblocks

A rare disease, also referred to as an orphan disease, by definition affects a small percentage of the population. Most are genetic and appear early in life, with one in three children with a rare disease dying before their fifth birthday. While the definition of “rare” varies from country to country, the US defines a rare disease as...

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...

Consulting

Developing & Negotiating a Study Budget

Over the course of more than 20 years in clinical research, I’ve sat in on more study budget development and negotiations meetings than I can count. What I’ve learned from those many thousands of hours of discussion is, whether you’re working with a global pharma company or a biotech start-up, the ultimate success of a...

Functional Service Provider (FSP)

Drug Development & Discovery – The Opportunity in Sharing Risk: A Productive Trend in Clinical Trials

Patient enrollment may be the single most important factor in ensuring the timely execution of clinical drug research. So when we negotiated risk-reward incentives for a trial evaluating a treatment for major depressive disorder, signing up participants accounted for most of the performance incentive structure: a significant double digit percent bonus (or penalty) tied to...