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Key Takeaways About Compliant IT Systems In The Cloud

This is the final post in our series on maintaining regulatory-compliant IT systems in the cloud. In this post, we’ll go over the key takeaways from the series and then we’ll send you on your way! Regardless of how much control you have over your IT systems, if you are using them for regulatory purposes, […]

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Tips And Best Practices For Compliance In The Cloud

As we’ve learned in the previous posts in this series, having a thoughtful, thorough cloud vendor qualification process and intelligent SLAs in your cloud vendor contracts will help you maximize the value of the cloud while maintaining regulatory compliance. In addition, here are some tips and best practices to help you knock it out of […]

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How To Use Contracts For Regulatory Compliance Of Cloud Systems

In my previous post in this series, we discussed how to qualify cloud vendors. Once that process is complete, the second step to maintaining compliance is to document your specific regulatory requirements in a contract with the cloud vendor, usually in the form of service-level agreements (SLAs). In this blog post, I include a range […]

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How To Qualify Cloud Vendors

We recently completed a 21 CFR Part 11 gap analysis engagement for a client that was largely using SaaS applications, but had no cloud vendor qualification process in place. They had just been allowing each business unit to select the applications that met its user requirements, accept whatever validation documentation the cloud vendor supplied (if […]

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Who Is Responsible For The Compliance Of Cloud Systems?

Any time you take advantage of a cloud service – infrastructure, platform, or software – for a regulated purpose, you are ultimately responsible for its regulatory compliance, not the cloud vendor. This is critical for you to remember. So, how can you ensure regulatory compliance of a software system you did not build, you do […]

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Cloud-Hosted Terminology: Types Of Systems

As we continue our series on maintaining regulatory-compliant cloud systems, let’s touch on a few key terms. Below are explanations of the primary cloud-hosted offerings available in the market. Infrastructure-as-a-Service (IaaS) When you purchase a software system and opt to have a vendor host it for you instead of installing it on servers you own, […]

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Refresher: Which IT Systems Are Regulated

If your company makes drugs, medical devices, or biologics (vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins), it is regulated. If your company is regulated, then every IT system you use to design, develop, conduct trials, manufacture, package, label, store, distribute, install, or service your products is also […]

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Maintaining Regulatory-Compliant Cloud Solutions

The benefits of cloud hosting – including Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and Software-as-a-Service (SaaS) – are very clear: less upfront capital, faster implementations, scalability and elasticity, and no need for individual companies to maintain physical space, hardware, and/or technical staff for support. But there are also several risks to consider, including physical and technical security, […]

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Top 5 Pharma & Medical Device Blog Posts From March 2018

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. Collaboration In Pharma Is Surging […]

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Interest In AI And Cognitive Is Rising In Pharma

Artificial intelligence (AI), cognitive computing, and machine learning are becoming more common in the industry. The need to scour and analyze large sets of data is giving life sciences companies new intelligence that would never have been realized before. The technology is making a big impact on healthcare decisions and patients. When it comes to […]

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Innovation And Digital Are Changing Life Sciences

The industry continues to flex its muscle when it comes to innovation through the use of digital technology. While life sciences companies over the years have tended to be laggards in this respect as compared to other industries, they’ve really come to understand the importance of using digital technology. It’s a necessity. It’s an integral […]

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[Guide] 2018 Pharmaceutical And Medical Device Industry Trends

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 […]

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6 Investigators Received FDA Warning Letters In 2017

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 […]

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Clinical Study Migrations: Technical Things to Consider

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 […]

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Top 5 Pharma & Medical Device Blog Posts From November 2017

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 […]

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Top 5 Pharma & Medical Device Blog Posts From June 2017

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 […]

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Why U.S. Prescription Drugs Cost So Much

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 […]

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How To Determine Whether Your IT System Is Regulated

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 […]

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It’s Official: Dr. Scott Gottlieb To Lead FDA

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 […]

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Happy May Day! Top 5 Life Sciences Blog Posts From April 2017

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 […]

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