Lets talk about Patient Engagement

March 12, 2019

Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are...


Exception from Informed Consent in Emergency Research

April 25, 2018

by Reshma Jagasia, Ph.D., Scientist by Nicole Tackmann, Ph.D., Clinical Strategy Intern All clinical investigations conducted in the United States...


The Current Implementation of the Drug Supply Chain Security Act (DSCSA) Implementation Plan and Rare Disease Drugs

September 21, 2016

What is the Drug Supply Chain Security Act (DSCSA)? In November 2013 the Drug Quality and Security Act (DQSA) was...


Jump on the Development Safety Update Report (DSUR) Bandwagon!

March 16, 2016

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Clinical Scientist, Canada. If you have an open Investigational New Drug application (IND) then...


The FDA Wants To Hear Patients’ Voices

January 27, 2016

The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced...


Top Five Mistakes in Clinical Protocol Design

October 9, 2014

By Lisa R. Sanders, Ph.D., R.A.C., Sr. Clinical Scientist II Almost a Holy Grail for the pharma/biotech world, the perfect...