Monthly Archives: September 2017

Chances are you’ve either personally dealt with osteoarthritis (OA) or know someone who has. This common type of degenerative joint pain represents both a heavy disease burden and a major opportunity for drug developers. Read on to learn more about: OA’s prevalence Optimal diagnostic criteria for clinical trials Treatment options What OA research looks likeRead more

Premier Research is proud to be a presenting sponsor of “Disorder: A Rare Disease Film Festival,” being held in Boston in October. Festival co-founder Daniel DeFabio shares with us why having such an event is important for raising awareness, sparking conversations and hopefully, maybe even a cure or two. A couple years ago, I madeRead more

We worked on a Phase II study of a drug to treat Fragile X syndrome that, like most rare work we do, was a challenge from the start. Fragile X is a rare and not fully understood genetic disorder, typically resulting from an expansion of the CGG triplet repeat within the Fragile X mental retardation 1 (FMR1) geneRead more

DURHAM, N.C., SEPTEMBER 25, 2017 — Premier Research’s Chief Medical Officer will discuss development of immuno-oncology molecules at Outsourcing in Clinical Trials Southern California, September 27-28 in La Jolla. Dr. Colin Hayward will address strategic and practical considerations for molecule development on the opening day of the annual gathering of pharma, biotech, and medical device leaders.Read more

Our seventh installment of The Placebo Problem continues our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. The placebo response is broad. It goes far beyond the effects of merely consuming a sugar pill; it is the patient’s response to theRead more

Before starting Phase I trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. The three major required areas of information in an IND include: Animal pharmacologyRead more

DURHAM, N.C., September 13, 2017 — Premier Research’s head of patient engagement will address patients’ emerging role in the development of novel drugs at the Global Genes RARE Patient Advocacy Summit in Irvine, California. Juliet Moritz, the CRO’s Executive Director for Patient Engagement and Strategic Development, will join Alvin Shih, CEO of the biotech companyRead more

This is the next installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Check out the other posts here. Over the past few weeks, we’ve discussed the psychological, neurobiological, and genetic mechanisms responsible for the placebo response. Today, we turn to the study designs usedRead more

 DURHAM, N.C., September 12, 2017 — Osteoarthritis is the leading cause of disability due to pain and the most common form of arthritis, afflicting an estimated 237 million people worldwide. At a live webinar on Tuesday, September 19 (11am EDT / 4pm BST / 5pm CEST), Premier Research will examine new approaches to one ofRead more

Strategic partnerships between sponsors and CROs are an important part of today’s clinical research landscape. When managed effectively, these relationships provide customers with collaborative strategic resources that drive optimized solutions. Partnerships help ensure the continuity of project teams and operations, development of best practices for continuous learning, and streamlined resource planning and staffing. They can also provideRead more

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