Premier Perspectives Blog

Insider Insights in Clinical Development

The inaugural edition of Premier Voices focuses on rare oncology drug development and takes a looks at: * Using adaptive design to limit patient exposure to ineffective treatments and increase the overall likelihood of success * Making the most of small and geographically dispersed patient populations * Dealing with limitations such as a lack of definedRead more

Premier Research recently contributed to the STARR 911 initiative, a project of the STARR Coalition to provide actionable guidance for clinical researchers after identifying volunteers with suicidal leanings. This post provides more information on the process itself, which was presented earlier this year at the 2018 ASCP Annual Meeting in Miami. Background The primary goalRead more

Having a chronic condition increases the odds of suicide by 363%, and patients with mental illness are particularly at risk.[1] For individuals contacting sites about possible enrollment in a clinical trial, the call may be their first attempt to reach out for help – yet many do not receive the education and support that couldRead more

While clinical investigations of medical devices and investigational drugs have their differences, what they do have in common is the goal of safeguarding the rights and welfare of study participants while bringing safe and effective products to market as quickly and efficiently as possible. Not all medical devices require a clinical trial, depending on theirRead more

It’s been 46 years since researchers Theodore Friedmann and Richard Roblin published a landmark paper in the journal Science that posed a provocative question: “Gene therapy for human genetic disease?” And while clinical trials for gene therapy drugs have become much more common in the past 20 years — more than 2,400 had been conductedRead more

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why weRead more

Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantables such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. To ensure the safety and efficacy of these devices, regulators expectRead more

This weekend, just in time for ASCO’s annual meeting in Chicago, we’re launching our new podcast, Premier Voices! Hosted by our own Paul Mirek, marketing manager at Premier, the podcast is aimed at sharing viewpoints and insights of our clinical research experts around the network and beyond. It’s our chance to get inside their headsRead more

Between navigating relatively uncharted territory and the practical limitations of most gene therapy delivery systems, ensuring successful clinical trials of these products is a serious challenge for even the most experienced researchers. Compounding this is the long-term nature of most gene therapy trials — it’s not unusual to have follow-up periods of a decade or more.Read more

Your compound holds great promise, and your investors are banking on a breakthrough. Which do you pick to run your clinical trial — a CRO that will share the risks and work with you to reach a common goal or a vendor who’s waiting on you to have all the answers? Any capable CRO can provideRead more

Like any new medical product, gene therapies must undergo rigorous approval processes. However, there are a number of additional regulations for gene therapies that don’t apply to conventional pharmaceuticals. This is especially true within the European Union. (It’s important to note that while most gene therapy studies are based in the U.S. and Europe — whichRead more

Gene therapy is a hot topic in clinical research today — and for good reason! These technologies have the potential to treat — and in some cases even cure — a wide range of conditions, including rare genetic disorders that previously had no effective therapies. What Is Gene Therapy? Gene therapies are a diverse group ofRead more

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