Featured Articles
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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.
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2021 State Of Clinical Trial Technology Industry Report
1/4/2021
How are clinical operations leaders making strategic technology investments in 2021 and beyond? This report provides insights from more than 200 respondents to the annual Florence State of the Industry Survey, from dozens of stakeholders who are members of the Florence Executive Advisory Board, and more than 8,500 study sites and more than 8,000 sponsors using Florence.
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How Remote Site Access Eliminates Clinical Trial Bottlenecks
12/14/2020
Sites, sponsors, and CROs now perform the bulk of their clinical trial operations by logging into cloud-based systems. Direct digital connectivity and collaboration access with your sites, via connecting to the largest Electronic Investigator Site Files (eISF) in research, eliminates clinical trial bottlenecks.
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7 Misconceptions About Managing Your Clinical Research In The Cloud
12/14/2020
In a world with more data and less time, the advantages of cloud-based technologies are hard to ignore. Debunk some of the common misconceptions of managing clinical research documents, data and workflows in a cloud-based technology platform.
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Why Open APIs Are Critical For Clinical Trial Software
12/14/2020
Today’s modern clinical trial requires robust and purpose-built eClinical solutions. One of the essential capabilities you must ensure exists is the ability to integrate with other systems through Open APIs.
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How To Create A Digitally Connected Clinical Trial Ecosystem
11/18/2020
Sponsors and CROs’ ability to access and collaborate with a research site is essential to the success of every study. As study sites “come on-line,” Sponsors and CROs are in a unique position to harness this digitally connected network of sites to turn on remote site access and Source document review/verification (SDR/V), and streamline workflows. In this article, we examine the key quality outcomes and technology recommendations associated with digitally accessing the site eISF.
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Six Reasons Why Sites Should Use The eISF Reference Model
11/18/2020
The Electronic Investigator Site File (eISF) Reference Model is the industry standard for setting up and managing an Electronic Investigator Site File. The rise in the eISF, coupled with an increasing need for real-time collaboration and document exchange among sites and sponsors/CROs, mandates the need for an eISF Reference Model. Here are six benefits of an eISF Reference Model.