Premier Perspectives Blog

Insider Insights in Clinical Development

We were reviewing a study protocol for a maker of medical devices, and there was one provision that just didn’t make sense. The sponsor specified a need for regular data monitoring committee meetings, but we didn’t see the need and couldn’t justify the effort. It was a short study involving few sites. In all likelihood,Read 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

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

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

Meet us at PCT Europe 2018! If the United Kingdom’s plan to exit the European Union evokes thoughts of a perilous road of steep grades and switchbacks, you’re pretty well attuned to the politically and commercially fraught process known as Brexit. More than two years after British voters elected to split from the EU, itRead more

Last week, we discussed the high placebo response that plagues neuroscience clinical trials. Today we turn to another common challenge: patient recruitment. We’ll take a look at three strategies that can be used to improve trial participation: the use of several patient sources when recruiting a focus on patient-centric solutions the use of patient recruitmentRead more

If you sell medical devices in Europe and haven’t made plans to comply with the EU’s new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), it’s time to step things up. The new MDR and IVDR rules adopted a little over a year ago do have generous phase-in periods — three years forRead more

21Neuroscience clinical trials, especially those for psychiatry and analgesia indications, have always had to deal with the challenge of high placebo response. Most troubling is that the placebo response rate seems to be on the rise, at least in the U.S.   Bigger placebo responses make it harder to show that an experimental treatment is effective. Indeed, higher placebo response has been linked to trialRead more

Most early-stage biotechnology companies have limited resources and manpower. As a result, early-stage biotechs conducting randomized clinical trial research often need a CRO’s help to deliver the quality data required to make their ideas and theories achieve practical purpose. In addition, engaging a CRO with a depth of strategic expertise early in the planning processRead more

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