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Welcome to the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. Update your topic preferences to receive additional Clinical Leader newsletters on:
- Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
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Decentralized Trials And RBQM: Keys To Reducing Risk For Small And Midsize Biotechs |
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With decentralized trials on the rise, more sponsors are moving toward the implementation of RBQM. However, with trial complexity presenting potential issues, sponsors are left trying to figure out what really matters to proactively manage trial risks. Read about where the true value lies with RBQM and how to save valuable time and achieve milestones with confidence with the right partner by your side.
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What Your Sites Love And Hate About DCTs
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From The Editor |
By Ed Miseta, chief editor, Clinical Leader,
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For years, sponsor companies have had access to new and emerging technologies that would ease the participation burden of patients in clinical trials. While these emerging technologies helped sponsor companies keep their trials on track, they have also been a burden for the clinical sites having to deal with the changes required to keep up with them. Do you know where your sites stand on the adoption of hybrid trials and DCTs?
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Top 3 Reasons Why A Direct-To-Patient Clinical Trial Is Right For You
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Article |
By Cheryl Robinson, Thermo Fisher Scientific
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Patient-centricity has been a growing trend across the pharmaceutical and biotech industries for some time now. As the focus on precision and personalized medicine continues to increase, sponsors are looking for innovative ways to increase patient enrollment and compliance while reducing drug development timelines and costs. The direct-to-patient (DTP) model has emerged as a potential solution.
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DCTs Deliver Big ROI
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White Paper |
By Bhausaheb Patil, IQVIA Research & Development Solutions
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In this white paper, Bhausaheb Patil, head of business operations for decentralized clinical trials (DCTs) at IQVIA, shares recently completed analysis comparing the tech-enabled model to traditional study models and showing how DCTs delivered time and cost efficiencies at virtually every point in the clinical research journey.
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How DCTs Differ Across The Clinical Trial Landscape
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Article |
Encapsia
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Whether virtually or in person, leaders emphasize that a holistic clinical technology platform is essential to enable decentralized clinical trials (DCT) today. Based upon the organization, clinical portfolio, and outsourcing model, DCT looks like many different things across the clinical trials landscape.
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Solutions For Decentralized Clinical Trials
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Brochure |
YPrime
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YPrime has the expertise to design and execute effective DCT strategies that take full advantage of the benefits of technology while meeting regulatory requirements and expectations.
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The Impact Of The Russia-Ukraine War On Clinical Trials
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Guest Column |
By Vladimir Misik, Ph.D., VIARES Academy
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While the export of lifesaving pharmaceuticals does not fall under sanctions for ethical reasons, all major pharma companies have vowed to stop new investments in Russia, including clinical trials. This author takes a "by the numbers" research look at the situation and analyzes where sponsor companies should reallocate clinical trials out of the affected region.
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A Phase 3 Study In Early Alzheimer’s Disease
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Case Study |
Worldwide Clinical Trials
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In a recent Phase 3 study focusing on mild cognitive impairment (MCI) and mild Alzheimer’s disease, discover how recruitment was completed within 22 months, randomizing more than 1,800 subjects after screening more than 6,000 patients.
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Preparation For Biotech Testing For Clinical Trials
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Article |
By Alexander Watt, Q2 Solutions
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In a clinical trial, proper planning of sample, testing, and data timelines helps ensure that everything can happen on schedule. Here are some considerations to make a clinical trial run smoothly.
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Debunking Common Myths About Clinical Trials
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Article |
By Craig Morgan, Oracle Health Sciences
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When it comes to clinical trials in particular, myths are common. From the view that clinical trials are dangerous, to the idea that participants don’t know the details of a trial or the treatments they might take, false notions persist. Unpack these myths in this blog.
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