Stan Woolen worked for FDA’s Office of Enforcement in the 1990’s, where he was tasked with a great deal of public speaking shortly after he became the Agency Bioresearch Monitoring (BIMO) Program Coordinator. He had years of experience on the ground with GCP and GLP, but found himself in need of shortcuts for helping him organize the tremendous amount of public speaking in front of
THE FUTURE OF CLINICAL RESEARCH: THE CHANGE IN THE AIR.
Some dread it.
Others create it.
Either way, you know it is inevitable.
The clinical research industry is no exception. Ever since James Lind’s famous scurvy trial in 1747,1 where he demonstrated the affliction could be cured by the consumption of oranges and lemons, the concepts, tenets, and processes of modern clinical research have been evolving. This is no
This is the second in a series of articles about medical ethics. In our last post, we reviewed the basics of medical ethics.
Welcome back to the Hart GCP knowledge series. In our last glossary series post, we reviewed the definition of essential documents found in the Good Clinical Practice (GCP) guidelines. In today’s post, we will dive a bit deeper into the Investigator brochure (IB).
Regardless of what holidays you celebrate this season, we here at Hart Clinical Consultants would like to wish you joy, peace, and love during this last month of 2016 and on into 2017.
This is the first in a series of articles about medical ethics. Medical ethics is a sub-category of bioethics, which also includes animal ethics and environmental ethics, according to the Internet Encyclopedia of Philosophy.
Join us as we recognize American Diabetes Month this November. This year, the campaign aims to raise awareness about the 29 million Americans with diabetes and to create a sense of urgency about this growing public health crisis. Approximately 1.4 million Americans over 20 are diagnosed with diabetes every year. It remains the 7th leading cause of death, with 69,071 deaths caused by diabetes and
Welcome back to the Hart GCP knowledge series. Today, we will dive into the definition of essential documents found in the Good Clinical Practice (GCP) guidelines.
Whether you are looking for a new job, looking to hire someone, or looking to expand your skills through volunteer work, the people you know, and the people they know, are one of your best assets.
Today’s entry is a follow-up to an earlier post about blinding in clinical studies, which you can see here.