Featured Articles
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How The Right Software Can Help Sites And Sponsors Navigate The FDA Approval Process
8/26/2021
Sponsors, CROs, and research sites in the U.S. have always understood the importance of the FDA approval process. But with the arrival of COVID-19 vaccines, the general public has started paying closer attention to the FDA’s actions.
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Remote Connectivity Is Now A Requirement In The Site, Sponsor, And CRO Relationship
8/26/2021
“Within hours, our clinical operations had to be fully remote. Patients couldn’t come on-site. Our team couldn’t get into the clinic. But we had to keep our studies on track and needed to continue to monitor patient safety,” says Catherine Gregor, Director of Clinical Research Administration for Vanderbilt-Ingram Cancer Center.
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Remote Site Access Solutions: 5 Questions to Include in your RFI
7/27/2021
Many sites in the current pandemic landscape have limited or restricted on-site monitoring visits, increasing the demand for remote site access solutions across the industry. Read how the accelerating digital transformation stems from sponsors and CROs needing access to essential regulatory documents and source data from their sites.
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How To Create An Effective Environment For Technology Transformation In Clinical Trials
7/6/2021
Shifting to remote processes is part of a broader healthcare trend but moving away from paper is very specific to clinical research. Most of the healthcare industry has already made this transition. To be successful, you need to go all-in on technology adoption, and it cannot be single-threaded or incremental. Organizations looking to create an effective environment for technology transformation can help make the process more seamless by taking into account three key considerations we cover in this blog.
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How Workflow Software Can Shift Space And Time
6/29/2021
Workflow software has the power to literally shift space and time. In this article we share some examples of how software can expand access for any process and describe specific applications and benefits for clinical research.
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Building The Connection Between Sites And Sponsors For Decentralized Clinical Trials
6/29/2021
The COVID-19 pandemic proved that patients can participate in clinical trials using video calls, apps, wearable devices, and visits to their local physician, not just by visiting the research site in person. However, these hybrid decentralized trials work best when there are software integrations between research sites and their sponsors. So how do you set up the site-sponsor connection and make decentralized trials effective and secure?
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Understanding Data Privacy For Your Clinical Trials
6/29/2021
While personal health information protections have been established for decades, today’s booming rate of technology adoption and complexity of data flows has created a new demand for how patient and participant data is collected, stored and shared among sites, sponsors, CROs, internal and external stakeholders. Now as we rapidly shift towards remote-enabled technology it is critical to understand how this regulation will impact your organization. The first step is understanding the basics.
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The Technology Landscape For Decentralized Trials
6/18/2021
Because decentralized clinical trials use technology to share data remotely, decentralized trials can’t succeed without the right software. But with dozens of clinical research platforms flooding the market, it keeps getting harder to figure out what they all do and which ones you need.
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How Decentralized Trials Will Impact Study Sites
5/24/2021
When we talk about decentralized clinical trials, we mean using technology to give patients easier access to research sites in their local area. This sounds great for patients, but how does it work for research sites? Here are five impacts clinical research sites can expect to see as decentralized trials become more common.
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Decentralized Trials: The Reality Behind the Buzzword
5/20/2021
The concept of decentralized clinical trials is not new, but in response to COVID disruptions, research operations leaders were forced in 2020 to accelerate their plans for remote and virtual trials. In response, decentralized clinical trials have become a primary innovation in the clinical operations ecosystem. But the meaning of the term “decentralized clinical trials” is not universally understood.