Posts Tagged ‘medical device’

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 […]

A couple weeks back, I launched a brief blog series about assessing and mitigating risk with regulated IT systems. This week’s post will cover the first part in a four-part approach you can use to do just that: assess and mitigate risk. Part One: System Regulated Status The first step is to determine whether a […]

Just last week, the house voted to repeal Obamacare, and much has already been covered in articles readily available on the internet. But the Senate has already stated they will write up new legislation that will take into consideration the House bill. No timeline for the Senate to produce its new legislation has been set, […]

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 […]

Because Siebel Innovation Pack (IP) 2016 was such a significant departure from previous Siebel versions, our clinical operations team devoted much of last year to beta testing it, helping Oracle identify and iron out the kinks. Now that we have finished our assessment of the risks and rewards of upgrading Siebel Clinical to IP2016, we […]

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 […]

The industry is all a-buzz with digital engagement initiatives for patients, but let’s not forget about clinical subjects and even site personnel. They’re technology consumers, just like the rest of us, and they crave clinical trials that are simple, easy, convenient, and engaging. As an advocate for sites and subjects, Perficient just published a guide […]

With Appian. Yes, Appian. “I have no idea what that is…” Yes, I can read your mind. Okay, okay, I’m not actually clairvoyant. But I do have a pretty good sense of the industry, and I know that Appian hasn’t become a household name, yet. But, the times they are a-changin’. Appian is a business […]

The United States is known for massive innovation across sectors, especially in the pharmaceutical arena. According to the Pharmaceutical Research and Manufacturers of America, in 2015 member companies of the advocacy organization invested more than $58 billion in research and development, making the pharmaceutical industry the largest investor in research and development of any sector. […]

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 […]

If that title compelled you to open this post, then you know what 21 CFR Part 11 is, and you also know – as my 12-year-old step daughter would say – “the struggle is real.” 21 CFR Part 11 is perhaps the most famous (or infamous!) regulation published by the U.S. Food and Drug Administration […]

Now that April 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 March – they’re ranked in order of popularity, with number one being the most viewed piece. Oh My, Where Has The Time Gone? […]