Life Sciences

OK, maybe that’s an overstatement. But, it’s worth mentioning that President Barack Obama briefly talked about “precision medicine” in his State of the Union address last week. Here’s what he had to say: Twenty-first century businesses will rely on American science and technology, research and development. I want the country that eliminated polio and mapped […]

Attaching files to a case is an important aspect of case management work processes. Typically one would attach source documents here, such as a discharge summary report, a hospitalization record, patient laboratory records, etc. Without formal integration to a document management system, it’s quite easy to maintain safety source documentation by attaching a file in […]

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 two posts in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Sections 11.1 – Scope and 11.2 – Implementation. It’s time to wrap up this mini-series with Section 11.3 – Definitions. Make sure no one is looking and then grab your decoder rings! In the table below, the actual language […]

Whether you’re using Oracle’s drug safety and pharmacovigilance solution, Argus Safety, a different application from another vendor, or even Excel to capture and manage adverse event data, our January 29th webinar, Features of a World-Class Safety System may be of interest. Dr. Rodney Lemery, the director of Perficient’s life sciences safety and pharmacovigilance division, is […]

If you’re a Java developer, you probably know that you can create a thread by implementing the Runnable interface or by extending the Thread class. You can then execute multiple threads in parallel to achieve concurrency. Still with me? It gets a bit more challenging when you need to spawn long-running tasks in parallel and […]

  Let’s face it, relying on clinical trial participants to self-report their medication intake isn’t ideal. Lots of things can go wrong. Patients can administer medication improperly, avoid taking the medication altogether, or even claim they’ve taken the medication when, in actuality, they haven’t. While there are other means of checking whether patients are taking […]

In a blog post from several months ago, Param Singh, director of clinical trial management solutions at Perficient, announced the newest version of our Siebel Clinical Trial Management System (CTMS) accelerator, ASCEND. ASCEND 2.0 includes Oracle’s new Open UI updates that make the system easier to deploy and run on a variety of browsers and […]

In the first post in this 21 CFR Part 11 Subpart A “mini-series,” we decoded Section 11.1 – Scope. It’s time to grab your decoder rings again while we take a look at the next Section, 11.2 – Implementation. In the table below, the actual language from each regulation is on the left, and my […]

I’m not here to debate whether you should vaccinate your kids. Instead, I’m here to share another perspective, article, and infographic that were forwarded to me by a bunch of my science buddies. They discuss the link between autism and vaccines, and were all just too good (in an appalling kind of way) to not […]

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 […]

  Throughout 2015, we should continue to see life sciences companies investing in technology to reduce drug and device development costs and time, and more importantly, to improve the safety and efficacy of their products. It’s no longer a choice, but rather a matter of time: life sciences companies need to upgrade their IT solutions […]