Life Sciences

Now that July 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 June – they’re ranked in order of popularity, with number one being the most viewed piece. What Exactly Is An “Adverse […]

A couple of months ago, I wrote a blog post on how to find and install the latest patchset release for Siebel IP2016. While we’re in the middle of 2017 and still waiting for IP2017 to be released, Oracle managed to sneak in another patch release for IP2016. Below are a couple of screenshots that […]

Due to the seriousness of adverse drug reactions, life sciences organizations perform something called “signal detection,” which is the process of evaluating potential safety signals. This entails looking at previously known associations between a drug and an adverse event, and looking at previously known drug-related issues that may be either improving or worsening. Not only […]

This is post #4 in a short series about assessing and mitigating risk with regulated software. Over the past few weeks, I’ve discussed the rationale for taking a risk-based approach to this topic, as well as the first couple of steps to take: determining whether a system is regulated and, if so, determining its risk […]

In the previous five posts in this series, I’ve taken you on a little journey designed to help you improve your relationship with your clinical sites, thereby boosting their performance and reducing your costs. In this, the final post in the series, I’ll summarize the key takeaways and offer up some additional resources to help […]

Imagine with me: An investigator running a site in one of your studies logs in to see an overview of his payment history. Something seems off, so he begins to review each payment in detail, and comes across what he believes to be the source of the problem – the withholding for his first payment […]

If you haven’t read the previous posts in this series, be forewarned that this week’s post might be a little hard to follow, as it assumes you have all of the context from the series to-date. Still, I encourage you to dive in, and I’ll do my best to connect all of the dots for […]

When I’m approached by clients to discuss safety projects, it is generally about implementing Oracle’s Argus Safety, upgrading the system, or discussing their ability to comply with regulatory requirements. Recently, I was asked about migrating from a legacy drug safety database to Argus. We discussed the methods available, such as leveraging an Oracle dump, a […]

In the previous posts in this series, I’ve explained why you should consider clinical sites as your “customers,” and what customer experience (CX) methodology is and how it’s used. In this post, I’ll explain how the methodology applies to clinical sites and how the insights it provides can help improve site relationships. With the notion […]

In the previous posts in this series on improving relationships with clinical sites, I discussed why it’s beneficial to think of your clinical sites as your customers so that you can use customer experience (CX) methodology to improve those relationships. In this post, I’ll explain what CX methodology is and why it matters. At its […]

Earlier this year, Duke University and the United States Food and Drug Administration (FDA) published a jointly conducted study focused on principal investigator (PI) retention. After surveying 201 PIs, they confirmed the industry’s suspicion that PI turnover is a serious issue: 54.2% of respondents reported that they completed a single clinical trial and then stopped. […]

Last time, I published a post that posed the question: why are prescription drugs in the U.S. so expensive? Today’s post is the first in a brief series that will attempt to provide an answer by looking each stage of the FDA drug approval process, starting with preclinical. Below are the key components of the […]