As a big fan of efficiency, it pains me that most of us in life sciences still execute validation testing with pen and paper, present company included. All of those poor trees. All of that hand-cramping. All of that scanning. All of those migraine-inducing QA reviews in which we’re squeezing scanned test cases into […]
Posts Tagged ‘medical device’
The 10 Most Popular Life Sciences Blog Posts Of 2015
Welcome to the New Year! Similar to the way we share our most popular blog posts on a monthly basis, it only makes sense to look back at the most viewed posts from 2015. So, here it goes, with number one being the most read piece.
The Industry Cloud Landscape Infographic That Caught My Attention
Gordon Ritter, co-founder and general partner of Emergence Capital, wrote an article in TechCrunch the day after Thanksgiving in which he spoke about the prowess of “industry cloud companies” – companies that develop software for specific verticals. “These companies might not be well-known outside specific industries, but ask anyone within an industry vertical and […]
Pharma Marketing: Communicating With Physicians
ZS Associates, a global company that offers sales and marketing solutions to a variety of industries, has released its 2015 annual report, which takes a comprehensive look at how pharmaceutical companies are marketing to physicians.
21 CFR Part 11 Compliance For CAPAs In Argus Safety
We recently discussed how Oracle’s safety system has the ability to produce ad hoc descriptive statistical reports on quality data. This brings us to the last rule we’ll discuss in our “Argus Safety for CAPAs” blog series.
The FDA Came Out With Its New Social Media Policy
For several years, the FDA has been the center of scrutiny for not having an official social media policy available on its website. According to the Union of Concerned Scientists, the FDA was the only one of 17 government agencies not to have social media policy…until now.
California’s Incredible Life Sciences Numbers
The California Life Sciences Association released a new report that proves the Golden State, once again, is at the top of its game when it comes to life sciences.
Ad Hoc Statistical Reports For CAPAs In Argus Safety
We recently touched on how Argus Safety enables you to track product complaint data and follow it through resolution. Today, we’ll discuss another CAPA rule the safety system supports.
The One STAT The Boston Red Sox’s Owner Wants You To Know
“…a news organization can be most nimble when it is built organically for the digital age.” – John Henry That’s what STAT is. John Henry, the owner of the The Boston Globe, Boston Red Sox, Liverpool Football Club, and Roush Fenway Racing, just launched a new digital publication that’ll solely cover the life sciences […]
Survey Says: Patients Like Being Involved In Clinical Trials
Several months ago I posted Why Don’t I See Ads For Clinical Trials?, a piece in which I questioned just that. In a society where healthcare is always front and center, how is it that most of us are still unaware of our options when it comes to participating in clinical research?
Recording CAPA Issues And Resolutions In Argus Safety
In our last CAPA-related blog post, we talked about the ability to attach supportive information to CAPA records (case data) in Argus Safety, Oracle’s drug safety and pharmacovigilance system. Today we’ll discuss another way the system can help comply with CAPA rules. CAPA Rule: System must allow the recording of issues and track their […]
The Smart Way To Find Qualified Patients For Your Clinical Trials
I’ve written a number of blog posts on the challenges of clinical trial recruitment, and that’s for good reason. According to Dr. Steven Alberts, Chair of Medical Oncology with the Mayo Clinic, only 5% of cancer patients ever enroll in a trial. On top of that, only a fraction of all trials ever complete […]