Life Sciences

  This is the third post in the 21 CFR Part 11 “mini-series” focused on Subpart B – Electronic Records. This time, we’re decoding Section 11.50 – Signature Manifestations. Do you have your rings ready? In the table below, the actual language from each regulation is on the left, and my personal interpretation of what […]

  19! That’s how many years the Oracle Health Sciences User Group (OHSUG) conference was held. I’d say that’s a feat for any user group conference, let alone for such a niche set of applications. But, really, couldn’t we have just made it to 20?! Even though you might have a soft spot in your […]

  It’s no secret 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 most robust system in the space. But, when integrated with other key systems, it becomes exponentially more valuable. Intrigued? Then, read on. Investigator Portal When Siebel […]

  It was exciting, fast, and, surprisingly, painless. Let me tell you take you back to last week. I got out of my car, walked a few hundred feet, and entered through the glass double doors. Behind the shelves of candy and healthcare products, what do I see? A MinuteClinic. No one was there to […]

  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 […]

  Medication non-adherence continues to be a big issue in the pharma industry, affecting clinical outcomes for both approved and unapproved drugs. And naturally, it increases overall healthcare costs. HealthPrize, a maker of medication adherence and patient engagement software, recently published statistics that further suggest gamification improves patient adherence to medication protocols, as well as […]

  As a company who implements and enhances clinical trial management systems (CTMS), a question we hear a lot is, “Do we need to validate our CTMS?” And, to be honest, it’s one we continue to debate internally. Why is the answer not black and white? Well, our internal debate always works its way back to […]

  In a recent post, I wrote how not giving principal investigators (PIs) the right systems (i.e., investigator portals) can lead to frustration, causing them to eventually withdraw from studies. Apparently, times are still rough for PIs and investigator sites. According to a new Tufts CSDD Impact Report and Wall Street Journal article, while the […]

  Super Bowl XLIX won the record for the most watched show in TV history. With over 114.4 million people tuning in, this was hands-down the biggest day for advertisers and the best time to show off your goods. Valeant Pharmaceuticals took this prime opportunity to showcase JUBLIA, the company’s answer to toenail fungus. While it […]

This post marks the first in the 21 CFR Part 11 series that is focused on Subpart B – Electronic Records. Since Subpart B contains four sections, its “mini-series” will contain four posts. Do you have your decoder rings handy? It’s time to decode Section 11.10 – Controls for Closed Systems. In the table below, […]

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. The systems covered in our review are: Oracle Systems Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS)

Now that February 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 January – they’re ranked in order of popularity, with number one being the most viewed piece. 6 Trends In Life Sciences […]