Consulting

Consulting

7th Annual LSX World Congress

February 1-5, 2021

There are more challenges than ever when it comes to innovative clinical research addressing the largest areas of unmet need. These challenges demand fresh solutions backed by the strength of experience. Premier Research is proud to once again join the health care and life science industries’ most forward-thinking executives at the LSX World Congress from...

Consulting

How to Navigate Global Regulatory Frameworks & Expedited Programs for Gene Therapy Development in the U.S., EU, & Japan

As scientific knowledge, clinical experience, and acceptance of gene therapy products have evolved, so have the regulatory frameworks for ensuring the safety of these novel treatments. To date, there is no harmonized international standard for regulating gene therapy products; however, the U.S., EU, and Japan have established regulatory frameworks with subtle variations. Understanding how gene...

Clinical Research: Phase 1 - Phase 4

Choose the Right FDA Program to Expedite Your Rare Oncology Trial

Rare cancers account for 27 percent of all new cancer diagnoses in the U.S. and 22 percent of all new cancer diagnoses in the EU.1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Faced with limited treatment...

Consulting

Dec. 8: Virtual Presentation – Effects of Digitization on Patients at the Center of the Clinical Study

8 December 2020 | 6:30pm CET Effects of Digitization on Patients at the Center of a Clinical Study: Regulatory Aspects, Initiatives And ExamplesPresented by Industrial Pharmaceuticals Division, German Pharmaceutical Society

Consulting

Beware of Underestimating the Value of a Pre-NDA Meeting

Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of...

Consulting

5 Tips to Avoid an IND Clinical Hold: Regulatory Guidance and Insights

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In this blog, we discuss common reasons for clinical holds and provide useful tips for both avoiding and addressing them. Brief background...

Consulting

Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

Professionals focused on drug development are charged with making the most of their resources, maximizing the value of their work, and bringing effective products to market as quickly as they can without compromising quality or safety. It is a long list of responsibilities, and development professionals struggle to balance all of them. Sameena Sharif, senior...

Consulting

Real-World Data and the FDA: How to Make Sure Your Data Counts

Stacy Weil, Vice President, Clinical Data Operations, Strategic Business Optimization, and Kristi Miller, Ph.D., Vice President, Regulatory Affairs, address the following: Expanded patient enrollment options when using RWDNew strategies for collecting and monitoring patient dataRecent regulatory reforms concerning acceptance of RWDCase studies illustrating the use of RWD for regulatory purposes What’s challenging you today? Fill...

Consulting

Entering a New Clinical Phase of Non-Traditional Data Sources

This is part two of a two-part series based on our recent webinar Setting a Real-World Strategy in an Evolving Clinical Research Environment. You can read part one here. In this post, we will cover non-traditional data points, their use in randomized control trials (RCTs), and how they contribute to a successful data strategy. The...

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...