Functional Service Provider (FSP)

Consulting

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...

Functional Service Provider (FSP)

How We Help: Getting Started With Premier FSP

Access our deep resource pool FSPs can drive down costs and make you even more agile We have created a flexible sourcing approach that gives operational teams the benefit of our clinical research expertise and access to our extensive resources. The advantages we offer can take many forms – from outsourcing to server hosting, from...

Clinical Research: Phase 1 - Phase 4

Expert to Discuss Trial Cost Forecasting at Industry Financial Summit

DURHAM, N.C., March 30, 2018 — Predicting the cost of clinical trials is a complex task, and more CROs are providing grant forecasting as a service to produce more accurate projections and give customers greater visibility. A grant forecasting expert from Premier Research will discuss new approaches to predicting trial costs in April at the...

Clinical Research: Phase 1 - Phase 4

Why Forecasting Trial Costs Is So Hard (and Getting Harder)

Forecasting the cost of clinical drug and medical device trials has never been easy, and as trials become more complex, estimating (and re-estimating) these costs becomes even more challenging. Lack of accurate forecasts has serious schedule and cost implications. By impeding effective cash management, inaccurate projections can lead to disruptions and delays that cost sponsors...

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...

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...

Consulting

Applied Clinical Trials – The Growing Role of Performance Incentives Between Sponsors, CROs

Clinical drug trials require enormous commitments of money and time, and sponsors are understandably motivated to ensure they’re run efficiently. Late patient enrollment, delayed site activation, and missteps during the course of the trial are just some occurrences that can raise the already high stakes in developing new therapies. So when we recently performed a...