Posts Tagged ‘medical device’

  2015 marks the 61st release of the Fortune 500 list. And while many of the same companies continue to make their annual appearance, we do see new names added to the list and some removed. For example, Medtronic did not make this year’s list, since it recently moved its headquarters to Ireland (companies have […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: In one of the initial slides, you mentioned that documents attached to emails do not fall under 21 CFR Part 11. Could […]

  Sponsors are known to work with multiple contract research organizations (CROs). And, depending on the agreement in place with each CRO, data can be captured in either the sponsor’s systems (CDMS and/or EDC) or the CRO’s. If the data is stored in CRO databases, there may come a time when it needs to be […]

  On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]

  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. 

  We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation. 

  Last week, the FDA released a new draft guidance document called Adaptive Designs for Medical Device Clinical Studies. While the title specifically calls out “medical device,” the document states the following: 

  As you may have read in our most recent “cloud fact or fiction” post, we confirmed that companies have the ability to perform system administration activities for solutions hosted in the cloud. Let’s now tackle configurations and customizations. 

  In our last “cloud fact or fiction” post, we discussed the ability to migrate clinical and pharmacovigilance data to the cloud. Let’s jump right in and talk about system integrations in the cloud. Claim #7: Clinical trial software in the cloud cannot be integrated with other systems. 

  It’s not in the San Francisco Bay Area or San Diego. Nor is it in North Carolina or Seattle. 

  Stock symbols remind me of the website domains. If you have something easy to remember, short, and reflective of your business, you’re golden. Even if you just own a great domain, without an actual business, there’s a slight chance you can strike it rich. Remember all those domain names being sold for crazy prices? […]

Abhishek Tamang, 4, looks on after receiving medical treatment, following the earthquake, at Dhading hospital, in Dhading Besi, Nepal on April 27, 2015. Reuters Photo/Athit Perawongmetha The situation in Nepal isn’t good. The death toll now stands at over 6,000 and is growing by the day. And many, many more are seriously injured or simply […]