Eugene Sefanov

Pretty bad and pretty funny. That’s how I’d summarize what the websites looked like for these 13 biopharma, medical device, and research organizations when they first made their mark on the World Wide Web. In honor of Throwback Thursday, we used Internet Archive’s Wayback Machine to poke fun at the companies many of us have come to […]

It’s probably a safe assumption that your organization made the switch to an electronic document management system (e.g., SharePoint, Office 365, Documentum, Alfresco, NextDocs, eDOCs DM) some time ago. Take a few minutes and think back on the underlying reasons for that investment. I’m sure the list you came up with includes things like keeping […]

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 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 […]

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 […]

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 […]

Digitally signing documents is easier than you might think. It’s also much faster than having to print, sign, and scan them. And, of course, there’s a significant cost-savings for companies that frequently mail and store hardcopy documents. A product like CoSign can be a great solution for companies, especially those in highly-regulated industries that require […]

Anyone evaluating clinical trial, clinical data, and safety management systems today will also need to decide whether to implement on-site or in the cloud. As each year passes, more and more companies are choosing the cloud for a whole host (pun intended!) of reasons. Over the next few weeks, my colleagues and I will examine […]

To drive a car, you need to have a driver. Well, unless you’re Google. Or Tesla, for that matter. The same goes for clinical trials: you can’t conduct clinical trials without investigators. While the comparison may be a stretch, it’s fairly easy to understand the key role investigators play in clinical trials. So, why are […]

Jody Trader, a pharmacovigilance and drug safety specialist at MMS Holdings, a CRO based in Michigan, recently published a blog post on whether or not Microsoft Excel was sufficient for capturing and reporting adverse events. Since validated safety databases, such as Oracle’s Argus Safety, are often costly, sponsors and CROs continue to use spreadsheets for […]