Posts Tagged ‘medical device’

  In a recent article, McKinsey & Company shared the results of 20 interviews with leading executives in pharma about the “digital revolution.” Through the interviews, McKinsey sought to learn how pharma companies plan to stay ahead of inherent changes in the age of digital. 

  On Tuesday, March 1, 2016, after being very ill for several days, I asked my husband to take me to the emergency room. I had been unable to keep food or drink down, and I had a very painful swollen mass in the right side of my neck/throat. In the ER, they determined that […]

  A 2015 article in The Huffington Post talked about some of the challenges of clinical supply management. The author, Loretta Cipkus Dubray of Global Clinical Connections, listed four issues: counterfeiting, technology, weather conditions, and local government/politics. Naturally, the technology bit caught my attention. 

A recent study published in American Academy of Pediatrics found that providing Asthma patients with medication before they left the hospital reduced ER re-admission rates, as opposed to the standard method of relying on patients to fill their own prescriptions. Medication adherence is a topic that we talk a lot about because of the significant impact […]

  Life sciences companies have long relied on paper-based business processes and been slow to adopt new technologies. The move toward electronic ways of doing business, specifically as it relates to clinical data, didn’t start to make headway until the late 1990s with the advent of electronic data capture (EDC) systems. It took over a […]

  In less than a month, Oracle will be hosting Oracle Health Sciences Connect Europe, a free event that is geared towards users of Oracle’s life sciences applications, as well as partners of the software company. The one-day meeting will take place on March 22, 2016, in London and will provide information on product roadmaps, […]

  Similar to many industries, but arguably one of the most challenging, the life sciences sphere undergoes regulatory and compliance changes. Each country, group of nations, and regulatory body proposes different guidelines at different times. And, even though it could take several years for the changes to go into effect, when they do, you’d better […]

  Dr. Robert Califf, a cardiologist who has spent most of his career at Duke University, was confirmed by the Senate on February 24, 2016, to be the next FDA commissioner, following President Barack Obama’s nomination in September 2015. 

  While some of you might be hoping that RBM is just a trendy idea that we’ll soon forget, I have to say that when regulatory agencies take the time to draft and produce guidance documents on the topic… 

  When we think of compliance, we think of consistency. Compliance depends on following the same processes and procedures over and over, across the board. After all, that’s why we have all of those SOPs, right? When we’re used to conceptualizing compliance this way, the notion of risk-based monitoring can certainly lead to cognitive dissonance. […]

  Let me preface: this is just me playing devil’s advocate. To be fair. To give a different perspective. There is an exorbitant amount of conversation going on about the sharing and publication of all clinical trial data, good or bad. The reason? To help others out. To advance science. To save lives. 

  Efficiency and compliance are two critical components in highly-regulated industries, especially when it comes to developing drugs and medical devices. Unfortunately, though, these are two areas in which many life sciences companies struggle and could significantly improve through IT solutions.