Premier Insights

Functional Service Provider (FSP)

Premier Insight 248: Outsourcing: You’re Now Free to Do What You Do Best

A Fortune 100 pharmaceutical company wanted to free itself from day-to-day administration of data operations. A small biotech company wanted to focus more on innovation than on data management. Both called Premier Research. Pharma, biotech, and medical device companies are increasingly turning to contract research organizations to outsource a wide range of activities through functional...

Consulting

Premier Insight 260: The Russian Connection: Recruiting Hard-to-Find Patients from a Specific HLA Subgroup

At first glance, it seemed no more complex than any other global, randomized Phase 3 study. The devil turned up in the details. First challenge: overcome early patient screening failure rate of 70 percent At first, screening failure rates were discouraging at best – between 60 and 70 percent. We responded quickly, by expanding the...

Data Management & Biostatistics

Premier Insight 245: Getting Creative: A Hybrid Answer When the Conventional Won’t Do

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...

Data Management & Biostatistics

Premier Insight 244: Data Management: A Growing Challenge, Made Easier

Every day, the world creates and stores 2.5 quintillion bytes of data. If you really must know, that’s 2,500,000,000,000,000,000 bytes. We’re piling it up faster than ever, too — so fast that 90 percent of the data that exists today was created in the past two years. Moving and sharing all that information is a...

Clinical Research: Phase 1 - Phase 4

Premier Insight 251: It Helps to Know What’s Going to Happen Next

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...

Consulting

Premier Insight 249: A High Unmet Need that No One Wanted to Talk About

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 250: A Study That Wasn’t Working Until Premier Research Stepped In

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 236: Fibromyalgia: Gaining Knowledge of a Little-Understood Disease

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...

Patient and Stakeholder Engagement

Premier Insight 253: Is it Safe or Not? Ask a Panel of Independent Experts

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...

Patient and Stakeholder Engagement

Premier Insight 255: Merging Science and Nuance to Treat Post-Traumatic Stress Disorder

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...