Operations

  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. 

There are various ways to achieve content targeting in a content management system. In SharePoint, some common terms which are associated with this feature are Audience Targeting, Security Trimming, Metadata etc. Today I am going to share an example which we recently implemented for our customer and which required advanced targeting rules. Scenario An internal […]

  We all 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) is the leader in the space. But, working in Clinical Finance, you might not know exactly how Siebel CTMS could help YOU take a load off. Let me […]

As new companies embark on the Digital Transformation leveraging Big Data, key concerns and challenges get amplified especially for the near term before the technology and talent pool supply adjusts to the demand. Looking at the  earlier post Big Data Challenges, the top 3 concerns were: Identifying the Business value/Monetizing the Big Data Setting up the […]

  Now that March is here, I thought it would be neat to look back at what our readers found most interesting last month. Below are the top five blog posts Perficient’s life sciences practice wrote in February – they’re ranked in order of popularity, with number one being the most viewed piece. 

  Welcome to the first post in the 21 CFR Part 11 “mini-series” focused on Subpart C – Electronic Signatures. We’ve come a long way since that first post in which we decoded what the name “21 CFR Part 11” even means, haven’t we? We are in the final stretch! Let’s get out our decoder […]

Microsoft Virtual Academy held the “Know it. Prove it.” 28-day challenge during the month of February 2015. The challenge was a month-long learning binge with 8 challenge tracks to choose from. Along with more than 55,000 people around the globe; I rocked the challenge during the month of February and leveled up my skills. As an […]

  Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, as well as our own clinical and safety systems. 

  When Hurricane Sandy struck the U.S. in 2012, it was devastating, to say the least. It damaged homes, businesses, and schools. No one in its path was left untouched. Even data centers were flooded and left without power, taking critical systems offline. Experiences like Sandy make you wish you had a plan in place […]

As companies start adapting to handle Big Data, the challenges still remains. Barring the obvious applications, the challenges of getting the value out of the new-found data continues to be on the top of the list. ROI’s and potential revenues are yet to be realized. As the technology and the usage becomes more sophisticated we will […]