The U.S. government recently disclosed the amount of time it takes to comply with the FDA’s requirements for the reporting and recordkeeping of human drugs and biologics, related to Investigational New Drug (IND) applications. It probably won’t come as a surprise that it takes an exhausting 22,801,297 total hours. Yes, you read that correctly.
Posts Tagged ‘pharma’
21 CFR Part 11 Decoded: Electronic Signature General Requirements
Welcome to the first post in the 21 CFR Part 11 “mini-series” focused on Subpart C – Electronic Signatures. We’ve come a long way since that first post in which we decoded what the name “21 CFR Part 11” even means, haven’t we? We are in the final stretch! Let’s get out our decoder […]
Don’t Wait For Another Hurricane Sandy
When Hurricane Sandy struck the U.S. in 2012, it was devastating, to say the least. It damaged homes, businesses, and schools. No one in its path was left untouched. Even data centers were flooded and left without power, taking critical systems offline. Experiences like Sandy make you wish you had a plan in place […]
If You Charge Too Much For Your Drugs, This Could Happen
Last month, I wrote about pharmacy benefit managers (PBMs), such as Express Scripts, cutting exclusive deals with pharmas who are willing to slash prices significantly, saving insurers and patients lots of money, not to mention removing competition from the game. So, what happened?
The Cloud Isn’t The Problem, It Might Be You
Earlier this week, The Wall Street Journal published an article on some issues that companies encounter when running their systems in the cloud. It points out that a considerable amount of money is wasted on resources such as unused power or even servers. That’s not a surprise. If you don’t know what you’re doing, mistakes […]
A Dose Of Technology At CVS’ MinuteClinic
It was exciting, fast, and, surprisingly, painless. Let me tell you take you back to last week. I got out of my car, walked a few hundred feet, and entered through the glass double doors. Behind the shelves of candy and healthcare products, what do I see? A MinuteClinic. No one was there to […]
Want A Reward For Making Yourself Feel Better?
Medication non-adherence continues to be a big issue in the pharma industry, affecting clinical outcomes for both approved and unapproved drugs. And naturally, it increases overall healthcare costs. HealthPrize, a maker of medication adherence and patient engagement software, recently published statistics that further suggest gamification improves patient adherence to medication protocols, as well as […]
This Is Bad News For Sponsors And CROs
In a recent post, I wrote how not giving principal investigators (PIs) the right systems (i.e., investigator portals) can lead to frustration, causing them to eventually withdraw from studies. Apparently, times are still rough for PIs and investigator sites. According to a new Tufts CSDD Impact Report and Wall Street Journal article, while the […]
This Was The Only Pharma Ad During The Super Bowl
Super Bowl XLIX won the record for the most watched show in TV history. With over 114.4 million people tuning in, this was hands-down the biggest day for advertisers and the best time to show off your goods. Valeant Pharmaceuticals took this prime opportunity to showcase JUBLIA, the company’s answer to toenail fungus. While it […]
The Complete List Of FDA Novel Drug Approvals In 2014, By Company
Big pharma is big business. Well, if they have products on the market, that is! So, who were the lucky companies that got novel drugs approved by the FDA in 2014? What were the drugs? And, what were the therapeutic purposes? Flip through the slideshow to get a glimpse of who was popping champagne well […]
What The NFL And Pharma Have In Common
There’s been a lot of hoopla around the NFL and their new partnership with Microsoft surrounding the Surface tablet, now deemed the official tablet of the NFL and, of course, Seattle Seahawks QB Russell Wilson’s favorite toy. The deal, in part, outfits NFL teams with tablets to improve communication on the field, photo viewing, and […]
Bug Tracking Systems Aren’t Just For Bugs
Here in Perficient’s life sciences practice, we use a defect tracking system as part of our application development process. It helps us keep track of bugs and resolutions as we develop and test, but there’s nothing particularly remarkable about it…except that we use it for another purpose too: to track problems with our QA controlled […]