A customer called on us to rescue a study that just wasn’t going well. (It happens a lot.) The challenge was to deliver data the company needed to make a go-/no-go decision at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat...
DURHAM, N.C., MARCH 24, 2017 — Premier Research is launching a smartphone-based patient reported outcome system to replace the paper diaries used in many clinical trials. Premier Mobile ePRO will give sponsors and researchers more accurate and timely patient reported data while reducing the burden on trial participants. “Any study is only as good as...
Sponsors of psychiatric clinical trials may face significant challenges in collecting robust, quality data to support the efficacy and safety of investigative compounds. Identifying and mitigating study design-, subject-, and site-related factors that may influence data quality as early as possible in program development can help to drive study success. Ensuring that psychiatric clinical trial...
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...
Imagine rebuilding the engine in an ambulance carrying a critically ill patient to the hospital. Got it? Then you have a pretty good idea what it took to put this pediatric rare disease trial back on track. A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was...
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...
The client asked the nearly impossible — a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it. So we...
Things were complicated enough to start. The customer, conducting a Phase 2/3 dose-finding/pivotal study for an adult growth hormone drug, changed its protocol midstream in response to regulatory feedback and was rethinking other aspects of the trial, adding to its complexity. For weeks, the sponsor’s requirements changed almost daily, severely testing an incumbent lab vendor...
Our customer was racing to beat a competitor to registration. One critical part of the timeline: Last patient out to database lock in two weeks. In sister studies that involved 800 patients at 90 sites. And several primary investigators who were heading off on vacation just when we needed their sign-offs on the data. We...
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,...