Regulatory Compliance

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 […]

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 […]

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 […]

The role of corporate finance in financial services firms has evolved as the demands for balancing growth, regulatory compliance and risk management become increasingly important. According to CFO Magazine and an AlixPartners survey, 71 percent of finance executives polled said their companies need to have access to more robust business information. What’s driving this demand? Firms must be able […]

Four years after the signing of Dodd-Frank, financial services firms have a better understanding of both the challenges and potential benefits for their organization. While financial institutions are starting to get a better grip on Dodd-Frank reforms, one area where regulators are still coming to grips with and finalizing guidelines is incentive compensation. In fact, Section 956 was […]

In ACA and QRS – Shoot for the Stars Part 1, I laid out the overall domains that are going to be used to score QHP plans offered through the Marketplace. In Part 2, I discussed some factors to consider for the data derived measures. In this blog, we will take a closer look at […]

New market forces and key drivers have forced financial services companies to redefine the way they do business with consumers and corporate clients. To enable long-term competitiveness, firms are thinking about new ways of thinking, innovation and executing winning business and technology strategies around: growth and profitability, new business models, risk management and efficiency and […]