Articles From Our Expert Network
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Decentralized Trials: Trends & Technology Propelling Home Healthcare Services
6/15/2021
Moving some trial site activities into patients’ homes has been shown to increase recruitment by 60% or more, and it typically maintains patient retention at over 90%. This article delves into research regarding trends and technology enabling decentralized trials.
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Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
5/5/2021
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more. Here's what you can do to position yourself for success.
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The 3 Secrets To Becoming an Effective Leader In Clinical Research
3/16/2021
Experience in clinical research provides a solid foundation, which better positions you to launch your career into management- and executive-level roles. However, you will move away from operational execution and will be called to develop the skillsets and level of confidence required to lead and guide teams. What are the 3 skillsets to understand, develop, and refine your journey?
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The Asia-Pacific Region: A Hot Spot For Clinical Trials
3/2/2021
The Asia-Pacific region has become the hot spot for conducting clinical trials. Why? There is an ease of regulatory compliance, a low cost of conducting studies, a growing patient population, and the presence of a few top clinical institutions acting as sites.
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An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials
2/2/2021
An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.
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Moving Up The Ladder In Clinical Research: How To Develop Management & Leadership Skills
1/26/2021
One of the biggest career jumps is from individual contributor to manager. Becoming comfortable with making more abstract contributions rather than providing tangible work and checking off your accomplishments is paramount.
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A Rose By Any Other Name … What Is A CRA Anyway?
1/5/2021
Ask any project team, or CRA for that matter, what the expectations are for this role and you’ll get vastly different answers. For many, the CRA is an all-knowing, all-purpose expert with a broad range of responsibilities. For others, the role is more focused on the monitoring and compliance aspects of study conduct.
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Starting A Career In Clinical Research: 7 Things We Wish We Knew
11/24/2020
The clinical research industry is facing a talent shortage that could become acute in the next decade. A main contributor to this shortage is a lack of focused intervention at every level to identify the skills, behaviors, and knowledge that will enable motivated candidates to begin and mature their careers in the industry.
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Are You At Risk For An FDA ClinicalTrials.gov-Related Monetary Penalty?
10/27/2020
The FDA has historically not initiated formal actions to enforce the statutory requirements to register and provide clinical trial data to the ClinicalTrials.gov data bank. However, industry is now on notice that the FDA is about to change its approach.
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How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data
10/14/2020
Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?