Posts Tagged ‘clinical trial software’

  Last week, I attended a webinar that showcased the results of a study on the adoption of clinical trial software in life sciences. The study was conducted by a working group led by the Tufts Center for the Study of Drug Development, CDISC, and Oracle Health Sciences, and the results reiterated what we already […]

  What do you do when the largest contract research organization (CRO) in the world agrees to appear in a video promoting several products? You watch, of course! Quintiles recently recorded a video that features the company’s president of clinical development discussing their use of Oracle Health Sciences solutions, such as Siebel Clinical Trial Management […]

  We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation. 

  As you may have read in our most recent “cloud fact or fiction” post, we confirmed that companies have the ability to perform system administration activities for solutions hosted in the cloud. Let’s now tackle configurations and customizations. 

  In our last “cloud fact or fiction” post, we discussed integrating systems that are deployed in the cloud. This week, let’s talk about system administration. Claim #8: Choosing a hosted clinical or safety system means relying on the vendor for system administration tasks. 

  In our last “cloud fact or fiction” post, we discussed the ability to migrate clinical and pharmacovigilance data to the cloud. Let’s jump right in and talk about system integrations in the cloud. Claim #7: Clinical trial software in the cloud cannot be integrated with other systems. 

  Inspired by our blog series from earlier this year, the head of our Computer System Validation team will be delivering a webinar on Thursday, April 23, 2015 aimed at “decoding” the 21 CFR Part 11 regulation. In the webinar, validation guru Sally Miranker will be reviewing the regulation point by point, offering up Perficient’s interpretation […]

  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. 

  Earlier this week, The Wall Street Journal published an article on some issues that companies encounter when running their systems in the cloud. It points out that a considerable amount of money is wasted on resources such as unused power or even servers. That’s not a surprise. If you don’t know what you’re doing, mistakes […]

  This post is the second in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. Pull out your decoder rings and let’s look at Section 11.30 – Controls for Open Systems. In the table below, the actual language from each regulation is on the left, and my personal interpretation of […]

Managing patient visit schedules during clinical trials can be a daunting task. However, with the right tools in place, organizations can significantly streamline this process and increase protocol compliance. That’s where a clinical trial management system (CTMS) comes into play. Imagine creating and editing study calendars that enable you to track visits and activities. Now […]

In the previous post in this series, we explained what the name “21 CFR Part 11” means and how the Code of Federal Regulations (CFR) is organized. In this post, we will actually dive into Part 11 and begin to decode Subpart A – General Provisions. Because Subpart A contains three Sections (Scope, Implementation, and […]