Posts Tagged ‘FDA’

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 […]

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 […]

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 […]

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 […]

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 […]

One of the key issues and perspectives we outlined in our recent State of the Life Sciences Industry guide was President Trump’s intention to reform the Food and Drug Administration (FDA) through the elimination or significant modification of regulations. Part of his recipe for reforming the FDA included bringing in a new head of the […]

In a time in which research and development costs are at an all-time high, The Wall Street Journal just shared how pharmaceutical companies are starting to look for outside help to fund trials: everything from phase II all the way through the commercial phase. Partnering with private equity firms, such as NovaQuest and Avillion, is […]

Happy May Day! Now that May 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 April – they’re ranked in order of popularity, with number one being the most viewed piece. My Colleagues […]

In the life sciences industry, many of the software systems we use must comply with federal regulations. The purpose of these regulations, such as U.S. FDA 21 CFR Part 11, is to ensure that the data being housed and produced by these software systems is accurate and trustworthy. When the FDA first introduced 21 CFR […]

When discussing the impact the United States’ new administration may have on pharmaceutical companies, GlaxoSmithKline’s Andrew Witty may have said it best: “I’ve had 30 years in this industry, and there’s never been a dull year. And there’s never been a year where it hasn’t felt challenging and interesting. And I suspect the next 30 years won’t be […]

Last month, Duke University and the FDA released the results of a jointly conducted study on principal investigator (PI) retention. The study was released early online, but the print version is being published in June in the journal of Contemporary Clinical Trials Communications, published by Elsevier. The purpose of the study was two-fold: 1) to […]