Life Sciences

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 […]

While there are many ways to define “adverse drug reaction,” let’s use one that is fairly simply to digest: an unintended, harmful response that is suspected to be caused by a medicinal product being taken under normal circumstances. According to some sources, adverse drug reactions are the sixth-leading cause of death in the United States, […]

In the previous post in this series, I discussed the process you can use to determine whether a particular IT system is regulated. That post described the first part of a four-part approach to assessing and mitigating risk with regulated IT systems. Today’s post will cover the second part – what to do once you […]

Clinical trials are the biggest expense in the drug development process, and there are myriad systems out there designed to reduce operational costs. In fact, Perficient implements, integrates, and hosts several of them. But, what we are seeing now in the life sciences industry is a growing awareness of front-line operations; that is, an interest […]

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) Perficient Systems ASCEND (Siebel CTMS) Generally speaking, we review release […]

Now that June 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 May – they’re ranked in order of popularity, with number one being the most viewed piece. How To Import Data Into Siebel […]

As you might know, by default, you can export data from any Siebel list applet. Here is where you invoke the export: Recently, I had a client who wished to disable the ability to export data from Siebel, except for in one particular view. I’ve never seen this documented anywhere before, so I thought I […]

E2B(R3) So, there we have it, the European Medicines Agency (EMA) has finally issued a statement, which confirms the date of release for the bigger, better EudraVigilance: November 22, 2017. Time to go into panic mode? Absolutely not. But, here are some of the things you should be thinking about as the deadline approaches: Training […]

In part one of this two-part blog series, we outlined a number of challenges that organizations face with clinical data reviews. In today’s post, part two of the series, we’ll take a look at how Oracle Health Sciences Data Management Workbench (DMW) can be used to tackle those challenges. DATA MANAGEMENT WORKBENCH (DMW) OVERVIEW When […]

The pharmaceutical and biotechnology industry is an incredibly rewarding place to work. We get to help patients feel better, more effectively manage their conditions, cure their diseases, and even prevent them from getting sick all together. But the life sciences industry is not without its challenges. According to a recent Pharmaceutical Research and Manufacturers of […]

It takes an average of 10 to 15 years and $2.6 billion for a drug to reach pharmacy shelves. While there are many steps in the process that contribute to this lengthy timeline and cost, no aspect of the process is more critical than proving the safety of a drug. Since a patient’s health is […]