When the going gets tough, the tough get … creative. The search for the best resourcing solution sometimes defies a single answer. That’s when Premier Research combines outsourcing, insourcing, and geographic flexibility to devise a hybrid solution. Rethinking data operations A small oncology-focused biotech company presented such a challenge when seeking to contract out its...
What do you do when patients are too embarrassed to talk about what’s wrong with them? It was a trial for fecal incontinence, and patients wanted help – they just didn’t want to admit it. We needed a new outreach and recruitment process, so we tried radio, outdoor, and subway. We rigorously tracked what worked...
No guesswork here. It’s a combination of experience and that often-overlooked scientific discipline called common sense. We were conducting a Phase 2b trial of a new treatment for nonalcoholic steatohepatitis, or NASH. And we knew three things: We knew that hepatologists would jump at the chance to enroll their patients, because the only existing treatment...
Joining in the elusive pursuit of fibromyalgia pain relief, a small pharmaceutical company engaged Premier Research for a Phase 3 trial following our completion of the product’s Phase 2 research. The compound under study: a muscle relaxer on the market for decades, repurposed for the possible treatment of fibromyalgia. The sponsor chose Premier Research largely...
When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...
When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...
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 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...
When does a clinical trial that falls short of its goal still constitute success? When the experience reveals invaluable lessons in how to avoid a repeat performance — and identifies a highly productive location for siting future studies. A large, multinational study of a drug to control inflammation in patients with recurring high-grade malignant glioma...
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...