News/Blog

Hart Health Hints: January is National Blood Donor Month

Hart Health Hints:
January is National Blood Donor Month

Did you know that every two seconds someone in the U.S. needs blood?  Or that less than 10% of the population eligible to donate blood does so annually?

Although researchers keep trying, it is still not possible to manufacture artificial blood, making blood donations a necessity to supply patients with lifesaving blood products.

The American Red Cross (ARC), which supplies

Essential documents Deep Dive: The clinical protocol and amendments

Hart’s Good Clinical Practice glossary series

Welcome back to the Hart GCP knowledge series. We have been reviewing essential documents, and we looked specifically at the Investigator brochure in our last glossary post. In today’s post, we will dive a bit deeper into what is required for a clinical study protocol.

The guideline defines a protocol as “a document that describes the objective(s), design, methodology, statistical considerations,

ALCOA. A framework for quality

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.

THE FUTURE OF CLINICAL RESEARCH: THE CHANGE IN THE AIR.
Some dread it.

Others create it.

Either way, you know it is inevitable.

Change.

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

Hart Health Hints: November is American Diabetes Month

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