Validation. Admit it – you cringed a little. It’s almost like a dirty word in our industry. That thing that slows down system implementations. That thing that adds a bunch of time and cost to IT projects. That annoying, but necessary, evil. Well, okay, it’s not really “evil,” per say. It is, after all, designed […]
Life Sciences
You Can Finally Stop Avoiding Those Horse-Sized Pills
It sounds like a funny topic, but it’s actually an unfortunate problem for many people – one in three, actually. When people struggle to swallow large pills (tablets and capsules), they tend to take less than the prescribed dose, or even avoid taking the medicine altogether. Either situation can result in making their medical conditions […]
This Recent FDA Warning Letter Shows You Exactly Why Quality Matters
“Quality, quality, quality.” You hear it all the time from your QA colleagues. There are so many forms to fill out, trainings to complete, procedures to read and follow, and internal audits to produce records for. Sometimes, it’s so overwhelming that we’re tempted to just tune it out. That is, until we read an FDA Warning […]
Bug Tracking Systems Aren’t Just For Bugs
Here in Perficient’s life sciences practice, we use a defect tracking system as part of our application development process. It helps us keep track of bugs and resolutions as we develop and test, but there’s nothing particularly remarkable about it…except that we use it for another purpose too: to track problems with our QA controlled […]
Working In The Event Assessment Screen In Argus Safety
In a previous post, we discussed that Oracle’s Argus Safety makes entering and managing adverse event cases relatively simple due to its intuitive user interface. For this post, we’ll discuss working in the event and product assessment screen and look at a few of its key features. One main requirement for any safety system is […]
Cloud Fact Or Fiction: Can You Always Access Your Clinical and Safety Data In The Cloud?
Last time, we concluded that the costs associated with hosting clinical trial software in the cloud can actually be less than for on-site solutions. In this post, we’ll tackle access to data and system uptime. Claim #4: Clinical or safety data stored in the cloud can be accessed at any time. Fact or fiction? Fact. […]
13 Life Sciences Company Websites, Then And Now
Pretty bad and pretty funny. That’s how I’d summarize what the websites looked like for these 13 biopharma, medical device, and research organizations when they first made their mark on the World Wide Web. In honor of Throwback Thursday, we used Internet Archive’s Wayback Machine to poke fun at the companies many of us have come to […]
How Software Vendors Can Survive The Life Sciences IT Gauntlet
The life sciences industry is up against some incredibly high standards from regulatory agencies worldwide – with good reason – so it makes sense that we, in turn, have incredibly high expectations of our vendors, especially IT. Because we have to be able to show complete traceability in our work, we need our software vendors […]
Maximizing Your Document Management System ROI Through Digital Signatures
It’s probably a safe assumption that your organization made the switch to an electronic document management system (e.g., SharePoint, Office 365, Documentum, Alfresco, NextDocs, eDOCs DM) some time ago. Take a few minutes and think back on the underlying reasons for that investment. I’m sure the list you came up with includes things like keeping […]
Happy Hour For Kids?
Are your children participating in the largest learning event in history next week? From December 8-12, many schools will be participating in the Hour of Code during Computer Science Education Week. The idea behind the Hour of Code is to introduce students to computer science and show them how easy coding can be through fun, game-based coding […]
Using On-demand Data With Dynamic Data Writeback In Spotfire
I have worked on a few clinical applications where adding little functions to existing applications can greatly improve an individual’s job function and subsequently benefit the company as a whole. Looking for these little gems isn’t time consuming or difficult as long as we are aware of the system’s capabilities and are able to capitalize […]
How Argus Safety Enables Faster Case Management Times
The electronic (or manual through the Safety Reporting Portal) reporting of post-marketed individual case safety reports (ICSRs) to the FDA will be required by mid-2015 (FDA, 2014), and the most efficient way to perform such activities is through an industry-proven adverse event reporting system, such as Oracle’s Argus Safety. Since this is the safety and […]