Life Sciences

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 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 […]

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 […]

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 […]

In our last “cloud fact or fiction” post, we discussed the cost of implementing clinical trial software in the cloud. This time around we’ll address the ongoing costs you can expect to see if you decide that hosting your applications in the cloud is the way to go. Claim #3: Ongoing costs for cloud/hosted clinical […]

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 […]

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 […]

We’re all users of software. Put us in front of two systems – one that looks outdated and unorganized, and one that looks good and structurally makes sense – and I bet you’d gravitate to the latter one. In fact, although I didn’t conduct a poll, I’m sure we’d all choose the latter. It’s not […]

I recently heard a segment on the radio about personalized medicine. Or “translational medicine.” Or “translational research.” Or “precision medicine.” Whatever you want to call it! Dr. Murray Feingold, a pediatrician and geneticist in the Boston area, painted a clear description of the term. He put it in words that all of us can understand. […]

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 […]

In my colleague’s last “cloud fact or fiction” post, he confirmed that clinical trial, clinical data, and safety systems can be implemented faster in the cloud than on-site because a vendor’s data centers, servers, and templates are ready for use by companies with strict regulatory and compliance guidelines. Today, I’ll discuss implementation costs. Claim #2: Clinical […]