Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]
Posts Tagged ‘pharmacovigilance’
CURE Ebola With THIS!
Just kidding. You may have read the story on TMZ of a New York businessman making big bucks off the panic surrounding Ebola. Guess what? The FDA hit him where it hurts. His site is down. Stop trying to trick the public. Stop being sleazy. That’s the message the FDA is sending to pharmaceutical, medical […]
Tracing The Roots Of Regulations
The life sciences industry is one of the most heavily regulated in the world, which can make it a frustrating space to do business. But, retracing the current mass of regulations back to their roots can be like the spoonful of sugar that makes the medicine go down…and might even make you feel kinda good […]
Nutrition Companies Are Regulated For Product Safety Too
The pharmaceutical and medical device industries continue to be under close scrutiny by the FDA when it comes to product safety and the reporting of adverse events. With stringent regulatory requirements that’ll make any company or patient cringe, there’s no way to hide from authorities. And, rightly so. But, guess what? There are also adverse […]
4 Ways To Submit A MedWatch 7-Day Report
Over the years we have seen some general confusion regarding the use of the FDA MedWatch 7-day report for fatal blood collection or transfusion reporting versus the standard 7-day alert requirement for FDA individual case safety reports from IND trials. Some of the safety systems that our company has worked with over the years do […]
Why Bother With Computer Systems Validation?
It’s no secret that validation can be a bear. All of that documentation and testing, the multiple phases with pesky transition gates, a million reviews and approvals…it can really slow down an IT project, which often leads to questions about why on Earth we bother with it. Well, it all traces back to rules and regulations […]
It’s Time To Send Your IT Hassles To Someone Else [VIDEO]
The other day, I was watching Cory Johnson interview Bryson Koehler, CTO and CIO of The Weather Company, on Bloomberg West. While the talk focused on The Weather Company’s business model, I thought several points during the discussion were quite relevant to life sciences companies. Frankly, they’re applicable to most industries. The Weather Channel, which […]
How Many Environments Do You REALLY Need?
A couple of weeks ago, a client of ours discovered a problem in the production (PROD) environment of one of their clinical systems. In the initial system implementation, they had opted for a single environment (without a sandbox, development, training, test, or validation environment), so they found themselves with no separate environment in which to […]
Canada’s New “Vanessa’s Law” Contains New Adverse Event Reporting Requirements
On November 6, 2014, Canada passed Vanessa’s Law, a new piece of legislation designed to protect patients from unsafe drugs and medical devices. The law comes after many complaints from citizens that the country wasn’t doing enough to oversee the safety of products sold in the marketplace or the clinical trials being conducted in the […]
Perficient’s Life Sciences Practice Lands On Fastest-Growing Bay Area Private Companies List
As 2014 comes to a close, a few last-minute accolades are being awarded. I recently wrote about BioPharm, a life sciences-focused IT consulting company that Perficient acquired in April 2014, being named to Inc. Magazine’s 5,000 fastest-growing private companies in the United States for 2014. Just yesterday, we received word that BioPharm was named to […]
Should You Be Afraid Of Ebola?
With the recent localized outbreak of Ebola in West Africa, much information and disinformation has made its way to the Internet and mainstreamed media outlets. Given the foggy haze of reality, I thought it would be helpful to publish a summary of important facts – as the science currently supports – about Ebola: how it […]
The One Feature CROs and AROs Love in Argus Safety
Oracle’s Argus Safety is a comprehensive safety and pharmacovigilance platform designed to enable pharmaceutical, biotechnology, and medical device companies, in addition to contract research organizations (CROs) and academic institutions (AROs) to focus on product safety and regulatory compliance. With the multi-tenancy feature in Argus Safety, CROs and AROs can provide services to multiple sponsors, while […]