Operations

  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 […]

In my latest post over at CMSWire, I’ve outlined a (very plausible) scenario whereby the groundswell of user preference for mobile form factors could– and perhaps, should– spell doom for the concept of the enterprise intranet.  This is “digital transformation” writ large for employee productivity. Sound a bit loony, coming from someone who loves to […]

  Obama’s $215 million precision medicine plan. UCSF’s hire of big data expert Dr. Atul Butte. It’s safe to say that data warehousing and analytics is hot among the life sciences and healthcare communities and there’s really no end in sight. Academic medical centers (AMCs), hospitals, and drug makers all over the world are already […]

  23andMe, the company’s whose mission is “to help people access, understand and benefit from the human genome” recently sent their database of hundreds of thousands of customers – me included – this infamous question: “What colors do you see in this dress?” Yes, this is the same dress that went viral last month. While […]

  I’m sure you’re aware that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is the industry leader. But, as a Site Monitor, do you know exactly how Siebel CTMS could help YOU find your Zen amidst all of the chaos? […]

  For as long as I’ve been implementing clinical trial management systems (CTMS) – nearly 20 years, now! – I’ve encountered the “Big Bang” vs. “Modular” debate. When Oracle’s Siebel CTMS first reached the market, the industry was in such dire need of better functionality that the companies implementing CTMS included every requirement under the […]

  Welcome to the final post in the 21 CFR Part 11 “mini-series” on Subpart C – Electronic Signatures, which happens to be the final section in the 21 CFR Part 11 regulation. Let’s polish up our decoder rings one last time for Section 11.300 – Controls for Identification Codes/Passwords. In the table below, the […]

For quite some time I have been sharing my experiences and knowledge around the new Office Graph app (utilizing machine learning) called Delve. It’s great to know that this feature is now public for all Office 365 business subscribers globally. Until now it was only available for “First Release” customers and but everyone who wishes to […]

  Much of the industry efforts to date for personalized medicine have been disease specific and myopic in nature. While I believe this was necessary to evolve and mature, some organizations are taking a broader view of their data using advanced analytics to identify patient populations for targeted therapies that take into account an individual […]

This post is a continuation of my previous blog post explaining advanced content targeting using SharePoint search. We saw earlier how to implement a custom token for the logged in user which filters incoming content in the search index based on the user’s profile attributes. Today we are going to look into creating display templates to […]

  It’s common knowledge that having a clinical trial management system (CTMS) streamlines and simplifies the running of clinical trials, and that Oracle’s Siebel Clinical (Siebel CTMS) is arguably the best out there. But, as a Clinical Research Associate (CRA), do you know exactly how it could make YOUR work life easier? If not, read […]

  The U.S. government recently disclosed the amount of time it takes to comply with the FDA’s requirements for the reporting and recordkeeping of human drugs and biologics, related to Investigational New Drug (IND) applications. It probably won’t come as a surprise that it takes an exhausting 22,801,297 total hours. Yes, you read that correctly.