Posts Tagged ‘clinical’

Knowing for certain what the future holds is impossible. Trends, on the other hand, are more predictable. In fact, there’s probably no better indicator of emerging or future trends than recent history. That is exactly how we determined the trends we anticipate seeing in the pharmaceutical and medical device industries in 2018. This guide does […]

It’s been awhile since I’ve written about FDA warning letters, so I thought I would take a look at the letters issued throughout the year and see if anything egregious (or at least interesting) came up. I was surprised to learn that the FDA issued letters to six separate clinical investigators, and I thought the […]

There are a number of essential technical considerations that should be evaluated when migrating clinical studies from one database to another. Is the target database new or does the incoming data need to be “merged” into an existing database? What if the source application has been customized? What obstacles can be expected? Where does regulatory […]

Now that December 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 November – they’re ranked in order of popularity, with number one being the most viewed piece. Top 25 Biotech Companies European […]

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

In the previous post, I talked about varying levels of scrutiny for data review and what happens when recording the user actions. In this post, I will talk about the importance of the user interface for a review. Successfully navigating requirements, design, development, testing, user acceptance and ongoing support of any application requires user involvement […]

Now that March 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 February – they’re ranked in order of popularity, with number one being the most viewed piece. How And Why I Use Oracle VM […]