Regulatory Compliance

There will undoubtedly be a wide range of financial services predictions and banking trends that will surface throughout the year which will make planning your organization’s top priorities in 2015 increasingly difficult. However, one thing is certain – risk and compliance continues to move to the top of the executive’s agenda. As financial institutions continue to experience an onslaught of cybersecurity threats, […]

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 […]

As we wrap up 2014, let’s take a look at the top 10 blog posts from our thought leaders. These blogs were published on Perficient’s Healthcare Industry Trends Blog. If you missed these you may want to take a look. #1. What the Market Says You Need in Your Patient Portal by Melody Smith Jones […]

U.S.-based Medical Device companies, take note: Between October 1 and December 23, 2014, the FDA issued 11 FDA Warning Letters to your peers. With an average of almost one per week, it’s clear that medical device companies are BIG on the FDA’s radar right now. While the Letters touch on nearly every aspect of the […]

As we wrap up 2014, I thought it would be neat to see what our readers were, well, reading. Without further ado, here are the top 10 blog posts Perficient’s life sciences practice wrote that seemed to be popular among readers. They’re ranked David Letterman-style, one being most popular (i.e., viewed). The One Feature CROs and […]

The clock is ticking as we are fast approaching the end of 2014 and are already focused on what’s ahead in 2015. Before we take a jump ahead into the next calendar year, I thought I’d give readers a look back at some of the great content produced this past year. Visit our Thought Leadership section […]

Quit with the boring pharma TV ads. I can’t remember the last time I saw one – well – that I remembered. Until now, out of the red corner…Valeant. Just imagine the jubilation Valeant is feeling right now. Alright, I’ll stop with the wordplay – at least until the middle and maybe the very end! […]

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 […]

“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits to produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out. That is, until we read an FDA Warning […]

In a previous post, we discussed that Oracle’s Argus Safety makes entering and managing adverse event cases relatively simple due to its intuitive user interface. For this post, we’ll discuss working in the event and product assessment screen and look at a few of its key features. One main requirement for any safety system is […]

The life sciences industry is up against some incredibly high standards from regulatory agencies worldwide – with good reason – so it makes sense that we, in turn, have incredibly high expectations of our vendors, especially IT. Because we have to be able to show complete traceability in our work, we need our software vendors […]

The electronic (or manual through the Safety Reporting Portal) reporting of post-marketed individual case safety reports (ICSRs) to the FDA will be required by mid-2015 (FDA, 2014), and the most efficient way to perform such activities is through an industry-proven adverse event reporting system, such as Oracle’s Argus Safety. Since this is the safety and […]