The concept of patient centricity is hardly new, but in recent months it has assumed new urgency as industry and regulators have had to adapt to an evolving landscape. The evolution is spurring substantial changes in how clinical trials are developed and implemented, as regulators revise their processes and issue updated guidance documents to encourage...
Skin diseases are the fourth leading cause of health afflictions, affecting nearly 900 million people worldwide. It’s not surprising, then, that there has recently been a noticeable increase in dermatology drug development. There are currently thousands of dermatology clinical trials planned or already launched, including a variety of programs investigating innovative, targeted therapies. Much of...
DURHAM, N.C., February 16, 2018 — Are expedited approvals of new drugs occurring at the expense of innovation? Nach Davé, Vice President of Global Regulatory Affairs at Premier Research, will explore the subject at Outsourcing in Clinical Trials West Coast 2018, February 21 in Burlingame, California. In his presentation, Faster Approvals but Less Innovation: Trend...
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 provide...
Both understanding the role of patient advocacy groups in building better clinical trials and improving the research process mean first taking a look at the history of orphan drug development in the United States and Europe. An “orphan drug” is a drug that treats a condition that fewer than 200,000 people have. Because rare diseases...
DURHAM, N.C., November 10, 2016 — Researchers developing treatments for neurodegenerative disorders face some of the biggest hurdles in planning and conducting clinical drug trials. Get advice on navigating this difficult terrain by attending a Premier Research webinar on Tuesday, November 15. Neurodegenerative Disease Research: Steps to a Successful Clinical Trial will describe a complex...
DURHAM, N.C., OCTOBER 27, 2016 — Medical device and diagnostic companies are conducting more clinical trials than ever, a trend that’s giving rise to new procedures and best practices for studies that differ in many ways from pharmaceutical trials. Register for this webinar focused on the evolution of device clinical research on Wednesday, November 2....
DURHAM, N.C., OCTOBER 3, 2016 — You’re starting a lengthy project that’s fraught with risk and could cost a billion dollars or more to complete. A couple of early missteps might spell disaster. Welcome to clinical drug research. Boost your odds of success with a robust project schedule and carefully executed startup plan. At MAGI’s...
DURHAM, N.C., SEPTEMBER 29, 2016 — Point-in-time “landmark” analysis, the standard in most chronic pain studies, may not be appropriate for evaluating single-dose drugs. Instead, an analysis strategy similar to that used in acute-pain research may be more effective, Premier Research’s top biostatistics expert will assert in a poster presentation at the American Statistical Association’s...
DURHAM, N.C., August 10, 2016 — Patient advocacy groups play an important and growing role in developing drugs to treat cancer and rare diseases, contributing to study design, recruiting patients, and even directly funding clinical trials. At a September webinar, Premier Research will team with rare disease advocacy organization Global Genes to explore this important...