Monthly Archives: February 2019

As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However, given that neither the U.S. Food and Drug Administration (FDA) nor the European Medicines AgencyRead more

DURHAM, N.C., February 28, 2019 — As part of its commitment to supporting the patient advocacy community and as a kickoff to Rare Disease Day on February 28 and March as Rare Disease Month at the company, Premier Research is announcing both a new scholarship for rare disease patient advocates in partnership with Professional PatientRead more

DURHAM, N.C., February 26, 2019 — The European Union’s new Medical Device Regulation will mean a lot of changes for device makers when it takes effect in May 2020. Now’s the time to prepare, and Premier Research will discuss how at a live webinar on Tuesday, March 12. Topics will include: When device makers needRead more

Months before Britons voted narrowly to leave the European Union (EU) in June 2016, then-U.K. Prime Minister David Cameron called a vote to withdraw from “the gamble of the century” and warned of dire political and economic repercussions. More than two-and-a-half years later, Cameron’s warning sounds more prescient than ever. Countless unanswered questions confront BritishRead more

This is the first of a three-part series. Read the other parts here: Part 2: Ensuring Study Start-Up Compliance With GDPR Part 3: Key Considerations for Clinical Trial Recruitment Since it took effect May 25, 2018, the European Union’s General Data Protection Regulation has been reshaping the way data is handled across every industry sector, includingRead more

The assignment sounded simple enough: Recruit 24 patients for a Phase I proof-of-concept study of inflammatory bowel disease. The first CRO that received the assignment showed how difficult it really was: They were able to recruit only nine patients in a year and a half. At that point, the sponsor asked Premier Research to stepRead more

DURHAM, N.C., February 5, 2019 — Premier Research has named contract research organization (CRO) industry and military veteran Dr. Mike Wilkinson as its new Chief Operating Officer. Dr. Wilkinson brings a diverse background of industry and public service to his role of overseeing the company’s day-to-day operations and advancing its mission to support the world’sRead more

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