Tag: case study

Consulting

Your Guide to 8 New & Revised Concepts to the IVDR

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this infographic, we highlight eight new and revised concepts presented to the IVDR.

Patient and Stakeholder Engagement

Premier Insight 273: Conclusive & Positive Results Delivered Ahead of Time – By Eight Months

Background Patients rushed to enroll almost as soon as word of the study got out. We were dealing with a significant unmet need: Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists. But there was no approved, effective pharmacologic treatment. And patients desperately wanted one. Objective With unanticipated interest...

Patient and Stakeholder Engagement

Premier Insight 270: A Rosacea Trial Failed Many Enrollment Hurdles.

Two large, parallel trials with 107 sites spread across the United States. Heavy competition for patients because of multiple competing treatments already on the market. And an advertising strategy that needed to attract more than 1,400 subjects fast enough to meet the sponsor’s aggressive schedule. Those were just some of the challenges we faced when...

Clinical Research: Phase 1 - Phase 4

Premier Insight 267: From KOLs to Patient Advocates, Using Every Tool to Fight a Rare Disease

Finding patients for trials in very rare conditions is difficult under any circumstances, and in this case the odds were really stacked high against success. The indication: a basal cell carcinoma known as Gorlin syndrome, a disease that manifests itself in large numbers of benign tumors that grow on various parts of the body. The...

Clinical Research: Phase 1 - Phase 4

Premier Insight 237: That Was Easy

Regulatory Submission Filed a Full Year Ahead of Schedule This case is a story with no drama. No sudden crisis.  No last-minute rescues. It’s about a clinical trial that ran perfectly from start to finish. And that in itself is a story worth telling. The sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID)....

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 247: Forty Percent Savings in Four Weeks: Yeah, We’re That Good

A U.S. pharmaceutical company needed an immediate outsourcing solution to replace an underperforming vendor. Not only was time critical, cost was, too. These new data specialists would be located offshore to reduce the sponsor’s overhead. Oh, and did we mention it had to be done fast? Higher performance, lower cost Premier Research stepped in and...

Functional Service Provider (FSP)

Premier Insight 246: Transfer and Re-Engage: A Powerful Path to Flexibility and Cost Savings

Functional outsourcing can produce significant savings and greatly increase flexibility in assigning resources. But any big change in staffing requires care to avoid personnel disruptions, keep projects on track, and comply with laws governing use of contract employees. Continuity matters Through its transfer and re-engagement strategy, Premier Research helps customers realize the productivity and cost...

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...