Monthly Archives: September 2018

DURHAM, N.C., September 27, 2018 — Premier Research, a leading provider of clinical development and consulting services to biotech and specialty pharma companies, has again expanded its presence in the Asia-Pacific region to include South Korea, Singapore, and Taiwan. The moves increase activities in Australia and New Zealand, where Premier has been conducting clinical trialsRead more

This episode, we’re proud to share the first part of our conversation with Alan Thomas, patient advocate and founder of Ataxia & Me, ahead of International Ataxia Awareness Day on September 25. Alan talks about his personal journey with ataxia and how he first got started with patient awareness. Follow Alan and Ataxia & MeRead more

DURHAM, N.C., September 20, 2018 — Implementation of Europe’s new medical device regulations in 2017 started a transition that gives device companies up to five years to fully comply with strict new quality standards. But exactly what is changing, and why? And how will the new MDR and IVDR rules affect the players in thisRead more

DURHAM, N.C., September 19, 2018 — Premier Research, a leading provider of clinical development services to biotech and specialty pharma companies, has named Karen M. Brown Vice President of Marketing. She is responsible for developing strategic marketing plans to the company’s commercial objectives, brand, and position in the life sciences industry. Ms. Brown has spentRead more

Put yourself in this scenario: Your compound is a newly validated mutated receptor that is present in only a limited number of cancer patients, and there is no approved diagnostic test. Your product, an antibody-like molecule that inhibits the receptor’s activity, also stimulates a potent immune response. Further complicating things, much of the preclinical dataRead more

Medical science is making significant advances in treating schizophrenia, but for all the progress we’ve seen, patients don’t benefit much unless they regularly take their medications. Second-generation (or atypical) long-acting injectable antipsychotic treatments (LATs) that ensure consistent administration of medication have become widely available over the past 15 years, but they remain a tough sellRead more

The European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) are putting a lot of pressure on the medical device industry. These are big changes with far-reaching implications, and if there’s a common denominator among them, it can be summed up in one word: more. In this episode of Premier Voices,Read more

DURHAM, N.C., September 05, 2018 — As global, multi-center medical device studies become more common, trial monitoring becomes more complex. At a live webcast on Wednesday, September 12 (11 a.m. EDT / 4 p.m. BST / 5 p.m. CEST), Premier Research will examine what it takes to ensure compliance with federal regulations, sponsor agreements, investigational plans,Read more

In this blog series, we’ve been discussing some of the challenges of conducting clinical trials in neuroscience. In our final post of the series, we turn to another major one: ensuring that assessments are conducted with high quality whilst also minimizing subjectivity. Rating subjectivity can make signal detection substantially more difficult, if not impossible. ThisRead more

Join us at SCDM 2018 for a session chaired by Sara Doolittle, Associate Director of Data Operations While quality assurance and data operations are generally considered separate entities in clinical drug research, in theory and in practice they are intertwined at multiple levels involving numerous stakeholders. Sara Doolittle, Premier Research’s Associate Director of Data Operations,Read more

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