Featured Articles
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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.
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How Trial Master File Management Is Transforming And What You Need To Do To Stay Ahead
4/12/2021
The failure to prioritize the TMF can leave sponsors and clinical research organizations (CROs) to appear disorganized, delay clinical trial completion, and, in the worst cases, fail at bringing treatments to market. Sholeh Ehdaivand, president and CEO of LMK Clinical Research Consulting, discusses the Trial Master Files (TMF) and its pivotal role in the future of real-time collaboration between clinical research sites and sponsors.
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Understanding And Evaluating A Remote Site Access Solution For Monitoring And Source Data Verification In Clinical Trials
3/15/2021
Remote site access is now a requirement for clinical trial operations. As you seek to transform your monitoring strategy and build your virtual toolkit, you must must be familiar with the capabilities available. The failure of a remote site access solution will result in disrupted site workflows, increased compliance risk, and ultimately delayed study timelines. The Florence team put together this list of requirements most sponsors and CROs look for in their selection process to help you make an informed investment in this new technology category.
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Seven Reasons Growing Biotech's Bring Their eTMF In-House
3/10/2021
Biotech companies starting their first few clinical trials typically do not have the resources to host an eTMF in-house. For this reason, they often outsource to a Clinical Research Organization (CRO) and use the CRO’s applicable software. If the study is successful and moves to subsequent phases, or if Biotech adds new studies to their portfolio, hosting the eTMF with subcontractors limits the Biotech from moving operations in-house or engaging new CROs. Continue reading to learn more reasons why Biotech companies are bringing their eTMF in house even if they outsource services to subcontractors.
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Why Remote Site Monitoring Is On The Rise And How To Deploy It At Your Organization
1/12/2021
The COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring. In this article, we explore challenges of traditional monitoring, benefits of remote clinical trial monitoring, how to deploy remote clinical trial monitoring, sponsor-deployed remote monitoring technology, and site-procured remote monitoring technology.