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Innovate Data with Artificial Intelligence (AI) in Healthcare

Artificial intelligence (AI) has established a dominant disruption in transportation, marketing and financial services, among other divisions. In the realm of healthcare, AI is gaining momentum and has the potential to considerably change the industry, from the exam room to the back office to the supply chain. Forrester predicts, “70% of enterprises are anticipated to […]

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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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The Importance of a Digital Strategy for Women’s Health Services

The strategy for women’s health and well-being has been widely discussed at global and domestic levels for many years. With life expectancy remaining higher for women than it has for men, a shift towards prevention and wellness, the rapid adoption of digital technologies improving accessing to a wealth of healthcare information and services at the […]

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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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Why Aren’t Any Business Intelligence Apps Using Graph Data

Business intelligence isn’t always about the facts. Don’t get me wrong, there will always be a place for dashboards and BI reports. Making business decisions without them is unimaginable so we all appreciate SQL based business intelligence systems with star schemas that point to meaningful fact values. One of the many lessons learned from the […]

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Data Lake as Aggregator – The Critical Role of the Catalog

My previous blog talked about a Data Lake using a Supplier-Aggregator-Consumer analogy and talking about the roles each of these parties play. One factor that is critical to the success of this approach is the use of a common vocabulary that ensures efficiency and effectiveness in the interactions and collaborations between the parties. The implication […]

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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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Argus Safety, Oracle Clinical & RDC Release Notes [July 2018]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, including: Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Generally speaking, we review release notes at the beginning of each month for the previous month. On occasion, there are no new releases and, therefore, nothing to […]

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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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Guidance For Early Adopters Of The TransCelerate SIP

In today’s post, the sixth in the series on the TransCelerate Shared Investigator Platform (SIP), we offer guidance and best practices for early adopters of the SIP. For more background information on TransCelreate or the SIP, or for guidance directed toward companies that have not joined TransCelerate or adopted the SIP, see the previous posts. […]

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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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Guidance On Whether The TransCelerate SIP Is Right For You

This is the fifth post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background, including benefits and challenges, see the previous posts. For those of you who have not yet joined TransCelerate, or who have joined but have not yet adopted the SIP, here are some ideas to consider in your […]

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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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Common Challenges In Adopting The Shared Investigator Platform

This is the fourth post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background on TransCelerate and the SIP, see the previous three posts. In today’s post, we’ll be looking at the common challenges pharma companies face as they work to adopt the SIP. If you happen to be a pharmaceutical […]

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Argus Safety, Oracle Clinical & RDC Release Notes [June 2018]

Perficient’s Life Sciences practice regularly monitors the software release notes for several Oracle Health Sciences applications, including: Argus Safety Oracle Clinical/Remote Data Capture (OC/RDC) Thesaurus Management System (TMS) Generally speaking, we review release notes at the beginning of each month for the previous month. On occasion, there are no new releases and, therefore, nothing to […]

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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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Why Companies Are Excited About The Shared Investigator Platform

This is the third post in a series on the TransCelerate Shared Investigator Platform (SIP). For more background on TransCelerate and SIP, see the previous two posts. In today’s post, we’ll be exploring the benefits of adopting the SIP. First and foremost, the SIP resolves one of the biggest complaints expressed by sites, which is […]

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How Microsoft Word “Protected View” Stops Information Leaks

Microsoft Word has long offered support for loading images and templates over the network.  This is a great feature within corporate environments because it facilitates the reuse of assets like logos and corporate document templates.  Unfortunately, these features can be abused by bad actors to obtain operational intelligence on individuals, or even to steal credentials.  […]

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Why The Shared Investigator Platform (SIP) Was Created

This is the second post in a series on the TransCelerate Shared Investigator Platform (SIP). For background information on TransCelerate, see the initial post in the series. Very few doctors serve as clinical investigators (approximately 3%), which means many investigators work with multiple sponsor organizations. Each sponsor organization has its own site-facing IT systems and […]

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Perficient Life Sciences

We monitor the pulse of the life sciences industry, from clinical to digital. Read about the trends, insights, successes, warnings, and solutions that move science forward.