Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

TrialSite News: Joining the Revolution in Dermatology Drug Development: Tips for Successful Clinical Trials

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...

Clinical Research: Phase 1 - Phase 4

TrialSite News: Going Virtual: How to Implement mHealth and Remote Monitoring in Your Clinical Trials

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...

Clinical Research: Phase 1 - Phase 4

Pursuing Parkinson’s Disease Gene Therapies: Strategies & Operational Requirements

While treatment of Parkinson’s disease has traditionally been limited to dopamine replacement therapy to alleviate symptoms, gene therapy studies have recently evaluated both non-disease-modifying and disease-modifying transgenes for Parkinson’s disease (PD) treatment, with encouraging results. Non-disease-modifying therapies have improved symptomatology, and disease-modifying strategies – including stopping PD-mediated cell death and/or regenerating lost neurons – show...

Clinical Research: Phase 1 - Phase 4

Premier Insight 271: Enrolling Sickle Cell Patients Is Tough – So We Got Busy

Kick off a study of a drug to treat sickle cell disease and you’re facing a tough climb. Experimental drugs for sickle cell are few and far between, so there is little in the way of clinical trial infrastructure. The patient population is demographically challenging, too, made up largely of socioeconomically disadvantaged people who find...

Clinical Research: Phase 1 - Phase 4

Considerations to Improve Patient Outcomes in Early Drug Development

Every drug development program must begin with an understanding of how the relevant key stakeholders factor into the development process. It’s not just a matter of courtesy; a comprehensive examination of the roles played by all participants has the potential to produce faster and more concrete results, leading to improved patient outcomes. Topics in this...

Clinical Research: Phase 1 - Phase 4

Premier Research: Not Just Life Science. Amazing Science.

This life is amazing. Each step. Each gaze. Alone, or together as one, from deep inside, comes who we are. Part science. Part magic. Amazing. Always moving toward the light of discovery. Driven by what’s yet unmet. Across the world around us, decoding the secrets of the worlds within us. We go where that work...

Clinical Research: Phase 1 - Phase 4

5 Key Takeaways: Insights on Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

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...

Clinical Research: Phase 1 - Phase 4

ePremier CTMS: The Central Organizing Principle for Successful Studies

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...

Clinical Research: Phase 1 - Phase 4

ePremier Study Start-Up: Where a Successful Trial Launch Begins

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...