Study Design

Clinical Research: Phase 1 - Phase 4

A New Era in Dermatology: Study Design, Regulatory Strategies, and Patient Participation

Explore dermatology trials from the vantage point of study design, patient access, data quality, regulatory considerations, and more This webinar explores the latest changes in dermatology trials in the areas of study design, patient access, data quality, regulatory considerations, and more. Learn what’s required to understand the disease burden, patients’ treatment goals, and other critical...

Clinical Research: Phase 1 - Phase 4

Resources for Childhood Cancer Awareness Month

Premier Research is dedicated to helping patients and families around the world overcome the burden of debilitating diseases, such as a cancer diagnosis. Cancer is a leading cause of death for children and adolescents, and there are approximately 300,000 children diagnosed with cancer each year around the world.1 With the help of better therapies, more...

Clinical Research: Phase 1 - Phase 4

Premier Insights From WODC

Watch Premier Research’s presentations from World Orphan Drug Congress 2020 below. Note: You must be logged into your WODC Swapcard account to view presentations Rare Disease Recruitment: Addressing Enrollment Hurdles and Differentiating Your Clinical Trial in an Increasingly Competitive Research Environment Jonathan Kornstein, Executive Director, Program Strategy, Rare Disease & Pediatrics, shares tips for overcoming...

Clinical Research: Phase 1 - Phase 4

PREMIER VOICES #14: Setting a Real-World Strategy in an Evolving Clinical Research Environment

Featured Guests Stacy WeilSenior Vice President,Clinical Data Operations, Strategic Business Optimization Stacy Weil translates Premier Research’s strategy into actionable data initiatives that enable internal and external customers to achieve the highest level of performance and success. Prior to joining Premier Research, Ms. Weil was Vice President of Clinical Data Operations at PatientiP.Read More Nach Davé,...

Clinical Research: Phase 1 - Phase 4

ASIST: Advanced Study Integrity Services Team

How has COVID-19 impacted your clinical study? Get the insights. The analysis. And the plan. The COVID-19 pandemic has altered the clinical trial landscape around the world. Keep your study on track with expert help from the Premier Research Advanced Study Integrity Services Team (ASIST). Premier developed ASIST to help biopharma companies like yours adapt...

Clinical Research: Phase 1 - Phase 4

Regulatory Challenges in Global CAR-T Cell Therapy Development

When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and...

Clinical Research: Phase 1 - Phase 4

Expert Reaction to a Study Looking at Caffeine and Pregnancy

A study, published in BMJ Evidence Based Medicine, looked at caffeine use and pregnancy. At Science Media Center, Dr. Adam Jacobs, Associate Director of Biostatistics, Premier Research, said: “I note the author has published 2 books on the dangers of coffee which in my opinion should have been included in declarations of interest for the journal article....

Clinical Research: Phase 1 - Phase 4

Novel Trial Approaches for Rare Cancer Patients

Best practices for managing ongoing cell and gene therapy trials Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each...

Clinical Research: Phase 1 - Phase 4

Setting a Real-World Strategy in an Evolving Clinical Research Environment

Presented byStacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization & Nach Dave, RPh., MSc, Vice President, Development Strategy Related Resources Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm? Data Driven: How Electronic Patient-Reported Outcomes (ePROs) Provide a Vital Opportunity to Capture Key Data Beyond the COVID-19...

Clinical Research: Phase 1 - Phase 4

Setting a Real-World Strategy in an Evolving Clinical Research Environment

Presented byStacy Weil, Senior Vice President, Clinical Data Operations, Strategic Business Optimization, & Nach Dave, RPh. MSc, Vice President, Development Strategy Since early this year, many standard clinical trial processes have been significantly disrupted. Patients have been prevented from attending regular physician visits. Clinical research associates who traveled regularly to study sites to review and...