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A strategic memorandum of understanding (MOU) has been signed between Premier Research and the Centre of Innovation in Healthcare (CIH), part of the leading academic institution National University Health System (NUHS) in Singapore. CIH is a one-stop hub that facilitates the clinical adoption of health innovations for maximum benefit to patients and the population. Through test-bedding,Read more

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 whenRead more

Premier Research is sponsoring the Orphan & Rare Disease session track at this year’s BIO International Convention, June 3-6 in Philadelphia. Our own Angi Robinson, vice president for clinical development services in rare diseases and pediatrics, will participate in the panel discussion Rare Finds: Innovative Clinical Trial Design for Rare and Orphan Diseases on JuneRead more

In March 2019, the FDA released draft guidance on the design and implementation of natural history studies to support the development of safe and effective treatments for rare diseases. The document, Rare Diseases: Natural History Studies for Drug Development,[1] addresses one of the major challenges sponsors encounter when developing therapies for rare disease: the lackRead more

They say that great leaders aren’t born, but grow into their positions through sweat and tears. No matter what stage in life, industry, or phase of your career you’re at, it is important to continuously strengthen your skills, and this ongoing development is one of the key values we look to foster in our teamRead more

DURHAM, N.C., March 19, 2019 — Chimeric antigen receptor (CAR) T-cell therapy shows enormous potential for treating many forms of cancer, including lymphoma, acute myeloid leukemia, and myelodysplastic syndromes. Oncology experts Brian Marks, BSc, DC, Senior Director and Ashley Jones, MSc, Project Lead will discuss these emerging therapies and their potential to unleash the body’s defensesRead more

Decades of painstaking research have recently begun to yield gene therapy products that are delivering meaningful benefits to human health. The approvals of voretigene neparvovec-rzyl (Luxturna) for inherited vision loss, tisagenlecleucel (Kymriah) for lymphoblastic leukemia, and axicabtagene ciloleucel (Yescarta) for lymphoma have ushered in a new era of therapeutics. With the rapid evolution of theRead more

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 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

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