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...
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...
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...
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...
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...
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 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...
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...
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 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...