Tag: featured

Consulting

BIO International: Discover the Latest in Innovative Rare Disease Trial Design

DURHAM, N.C., June 5, 2019 — Premier Research is sponsoring the Orphan & Rare Disease session track at this year’s BIO International Convention, June 3-6 in Philadelphia. Our own Angi Robinson, vice president for clinical development services in rare diseases and pediatrics, will participate in the panel discussion Rare Finds: Innovative Clinical Trial Design for...

Consulting

A Primer on Cancer Immunotherapy

In recent years, immunotherapy has led to substantial advances in cancer therapy. In particular, the immune checkpoint inhibitors — PD-1/PD-L1 and CTLA-4 inhibitors — have revolutionized treatment for certain hematologic malignancies and solid tumors. To date, the U.S. Food and Drug Administration (FDA) has approved immunotherapies for more than 15 cancer indications. However, widespread use...

Consulting

FAQ: How the EU Medical Devices Regulation Affects Existing Products

With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU MDR compliance. Is it possible to avoid compliance with the EU MDR? The short answer...