Overview What is GxP? GxP refers collectively to several different types of “good practice” quality guidelines and regulations, each serving a specific purpose. In pharmaceutical product development, these include but are not limited to: GCP (Good Clinical Practice)GLP (Good Laboratory Practice)GMP (Good Manufacturing Practice) GxP standards broadly cover what are commonly referred to as the...
New treatment options for moderate to severe dermatological diseases and areas of high unmet need are driving a revolution in clinical development of dermatology drugs. But questions remain: What indications should be pursued? How to design a study that targets the right endpoints? And how will environmental constraints affect the research? In this three-part series,...
Gene therapy development is gaining momentum. In 2020 alone, gene therapy attracted $12 billion in global financing through just the first three quarters with more than 370 gene therapy clinical trials underway worldwide.1 The U.S. Food and Drug Administration (FDA) itself predicted it may be approving 10 to 20 gene therapies per year by the...
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...
In the year since COVID-19 brought all normal activity to a halt, clinical trial professionals around the world have been forced to re-examine their strategies. What happens when neither patients nor clinical research associates can visit trial sites? How can data collection and data monitoring occur — and critically, how can researchers deliver clean, concise...
Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the...
Across the industry, most trials don’t have access to real-time results…which leads to delays. 95% of those delays last longer than a month. Addressing this challenge means tackling the underlying problems of data being held in disparate places, and failure to predict and address risk. Our Premier One Ecosystem captures all the data related to...
Industry-wide, spreadsheets have long been the go-to method for tracking clinical trial start-up. Premier Research developed the Premier One Ecosystem to create a paperless, electronic data process, start to finish. Trials begin with our Study Start-Up application, which automates collection of ALL the data related to your trial, then optimizes it to decrease cycle times...
Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and over $2 billion to successfully bring a new drug to market, and only 10% to 15% of products ultimately receive regulatory approval.[1] A comprehensive plan and the right regulatory and therapeutic expertise can significantly accelerate the...
In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent...