ERT Clinical Applications Not Susceptible to Heartbleed OpenSSL Exploit
Message to our customers regarding Heartbleed security bug – ERT clinical applications were not impacted: As widely publicized, there was a recently discovered vulnerability detected within a very popular encryption software known as OpenSSL. This vulnerability, known as Heartbleed, allows internet traffic, …Read More
A Global Crisis – The War on Suicide in Japan
Dr. Rene Duignan, not a professional film-maker but an Irish economist, was driven by a personal regret to create a film that would shed light on the crisis of suicide in Japan. Rene’s award winning documentary Saving 10,000 — Winning …Read More
Regulatory Trends in Reviewing Risk/Benefit Assessments: U.S. FDA Perspective
Today’s blog will discuss regulatory trends in reviewing benefit/harm assessments in medical interventions. The important question here is: how do we balance the two? When we use the term “benefits” we are referring to “the good” that actually happens to …Read More
Drug-induced Hypertension – Potential New FDA Guidance?
Last month, we introduced Ambulatory Blood Pressure Monitoring and its use in clinical trials. Today, we will discuss drug-induced hypertension and why regulatory agencies, such as the FDA, have recently shown some concern. Some classes of drugs are known to …Read More
Why Use Ambulatory Blood Pressure Monitoring (ABPM) in Clinical Research?
Written by: Dr. Robert Kleiman, Chief Medical Officer & Vice President, Global Cardiology Hypertension, or high blood pressure (BP), is one of the leading risk factors influencing the global burden of cardiovascular disease, resulting in an increased incidence of cardiovascular mortality, …Read More