As a member of senior management, you undoubtedly know that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) offers an extensive list of features. But, as a Clinical Executive, what you might not know is exactly how it would make […]
Posts Tagged ‘clinical trials’
Search. Open. Close. Open. Close. Save Me, Google Search!
If you look at the numbers, it’s evident that Google is the leader when it comes to web search. There’s no contest. So, it should be no surprise they also happen to be the champion of enterprise search, enabling companies to quickly and accurately scour their multitude of databases all at once across the […]
21 CFR Part 11 Decoded: One Final Look
This is the final post on the series dedicated to decoding the mystical “21 CFR Part 11” regulation that governs IT systems in the life sciences industry. How does it feel to have made it all the way through? I hope that, by now, you’re feeling much more comfortable with the purpose, organization, and […]
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 […]
The Huntsman Cancer Institute Is Beautiful
The Huntsman Cancer Institute (HCI), an academic research hospital designed and founded by Jon Huntsman, Sr., a cancer survivor, well-known businessman, and the father of Utah’s past governor Jon Huntsman, Jr., recently put out a heartwarming commercial that showcases why it’s different from any other cancer treatment center. Aside from the unique look and feel of […]
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 […]
You Can Finally Stop Avoiding Those Horse-Sized Pills
It sounds like a funny topic, but it’s actually an unfortunate problem for many people – one in three, actually. When people struggle to swallow large pills (tablets and capsules), they tend to take less than the prescribed dose, or even avoid taking the medicine altogether. Either situation can result in making their medical conditions […]
Tracing The Roots Of Regulations
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 […]
Why Bother With Computer Systems Validation?
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 […]
It’s Time To Send Your IT Hassles To Someone Else [VIDEO]
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 […]
Canada’s New “Vanessa’s Law” Contains New Adverse Event Reporting Requirements
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 […]
Wait, You’re Not Using an Investigator Portal?
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 […]