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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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Upcoming Blog Series On TransCelerate Shared Investigator Platform (SIP)

In an industry that has historically been siloed and secretive, the nonprofit collaboration known as TransCelerate BioPharma, Inc. (TransCelerate) is a clear indicator of change. It was formed in 2012 by a group of innovative thinkers and doers from a handful of leading life sciences organizations, with the mission to “collaborate across the global biopharmaceutical […]

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Argus Safety, Oracle Clinical & RDC Release Notes [May 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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Extreme Customer Experience Makeover

Digital innovation continues to disrupt industries at lightning speed. Today’s organizations are transforming their entire business – from strategy to operations, technology to culture – to better deliver value to their customers. In 2017, we compiled the top 10 trends leaders needed to know when it came to their digital transformation journey. In this 10-week […]

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Working With Multiple LOCAL_XE Databases In Siebel IP2016

In Siebel IP2016, the Sybase database was replaced with Oracle’s own XE database. The switch has presented some advantages and some drawbacks. One of the advantages is that you can have multiple instances. In my case, I have one instance for each IP2016 project that I am working on. This is the blog that I […]

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Argus Safety, Oracle Clinical & RDC Release Notes [April 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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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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Join Us At Oracle Industry Connect 2018

Perficient is sponsoring Oracle Industry Connect April 10-11 in New York City, and we would like our valued clients to be there. Several key representatives from our life sciences practice will be available to discuss any of your ongoing or upcoming initiatives. Mike Grossman, General Manager Dennis Dougherty, Business Development Executive Rudolf Coetzee, Business Development […]

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What Is OracleXEConfig?

A new utility was provided with Siebel version 16.0 (i.e., IP2016) that is quite useful. OracleXEConfig allows you, as a developer, to have multiple Oracle XE instances on your computer and enables you to quickly switch to one that is active. It also allows you to create empty local databases. This is extremely useful if […]

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How To Free Up Disk Space For The Installation Of Siebel IP2016

I recently started working on a project where I am using Siebel IP2016. IP2016 uses Oracle XE for local development and requires a lot of free disk space to create and initialize the local database. I use Oracle’s excellent (and free!) VirtualBox version 5.2.8. The specific virtual machine that I was using was a Windows […]

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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.