THOUGHT LEADERSHIP

The development of the Package Insert (PI), also known as the Product Information, Prescribing/Prescriber’s Information, or simply “the Label,” is a long, complex process typically managed by a regulatory professional. It is a collaborative document, incorporating contributions from chemistry, toxicology, medical/clinical, biostatistical, writing, and regulatory professionals. Drawing from experience on a recent project, I would like to focus this installment of Protocol to Package Insert on the derivation of the clinical safety data that appear in the PI.

AICROS, the Association of International Clinical Research Organizations, is a consortium of small to mid-size CROs that collaborate to provide clinical research services to the biotechnology, pharmaceutical and device industries worldwide. PROMETRIKA joined AICROS in 2018 and on May 29 -30th, PROMETRIKA’s Head of Clinical Operations, Heather Paden, attended the AICROS Annual meeting, which took place in Kaunas, Lithuania.

Quick – What is BIMO? Is it a flying superhero? Is it an energy drink? Is it the next reality TV show? (Well, it is reality.) Here is a brief overview of BIMO and how it came to be.

Recently, our own Nicole LaVallee, PhD (Director of Biostatistics) and Miganush Stepanians, PhD (President & CEO and senior advisor in Biostatistics) collaborated with the scientists at Boston Children’s Hospital on analyses of the Angelman Syndrome Natural History Study. The results of this collaborative effort were published in the American Journal of Medical Genetics.

Last Thursday saw the 12th annual celebration of Rare Disease Day – an international day of recognition when hundreds of events take place around the world.