Life Sciences

  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 […]

  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 […]

  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 […]

  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. 

  This post is the second in the 21 CFR Part 11 “mini-series” that is focused on Subpart C – Electronic Signatures. Today, we’ll be using our decoder rings to learn the secrets in Section 11.200 – Electronic Signature Components and Controls. 

  In our last “cloud fact or fiction” post, we identified several reasons why hosting clinical and pharmacovigilance systems is just as safe as housing them on-premises. In fact, in many cases it could prove to be safer. This week we’ll briefly discuss migrating data to the cloud. 

  Much like the Coding Review screen, the Medical Review screen is functionality in Oracle’s Argus Safety that displays the relevant case in a single central window and allows a medical reviewer to see all of the key data points that he or she would use when assessing the case.