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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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Webinar: Hard-Earned Lessons From Clinical Trial Implementations |
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How can companies implement new clinical software and technologies more effectively? And how can they avoid common pitfalls? Join Clinical Leader Live as we feature a panel of experts to share their insights, best practices, and real-world examples of what has and hasn’t worked. This event is free to attend thanks to the support of Medrio.
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What Astellas Has Learned About Decentralized Trials
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From The Editor |
By Ed Miseta, chief editor, Clinical Leader
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When the COVID-19 pandemic hit in the spring of 2020, many companies were unprepared for the changes that were about to impact their studies. Astellas is one company that was better prepared than most. The company had initiated a formalized, internal project on decentralized clinical trial (DCT) technologies and their use in clinical trials about nine months prior to the pandemic.
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Self-Collection Safety Liver Panel
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Datasheet |
Q2 Solutions
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Clinical trials are becoming increasingly decentralized, and Q² Solutions is committed to discovering innovative ways of improving the patient and investigator experience.
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A Firsthand Experience In Africa: Sub-Sahara Has A Lot To Offer
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Guest Column |
By Kamila Novak, KAN Consulting
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In “Better Than Expected — A Firsthand Experience In Africa,” Kamila Novak shared her positive impressions from visiting medical research centers in sub-Saharan Africa. However, the picture would not be complete without talking about the continent’s personal safety and professional security, regulatory landscape, and ongoing socioeconomic challenges.
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Nephrology Patient Safety Starts In The Clinical Trial Setting
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Article |
Biorasi
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Is the clinical trial setting the best environment to ensure a patient’s safety? Dr. Jamie P. Dwyer discusses how nephrology clinical trials identify future patient risk factors for medication and treatment in the real-world setting.
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How Clinical Trial Complexity Impacts End Users
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Article |
4G Clinical
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This article examines clinical trial complexity through the lens of study investigators, site staff, CRAs, sponsor study and supply managers, and how the RTSM/IRT provides the ability to be as creative as needed.
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Strategies For External Comparator Arms Leveraging Real-World Insights
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White Paper |
By Emily Bratton, Ph.D., Cassie Holt, Ph.D., Sarah Kromrey, Ph.D., and Jeffrey Keefer, Ph.D., IQVIA Biotech
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This paper explores essential principles for defining the right strategy for natural history studies and how to design such studies in a way that the data can be used as an external comparator to augment future regulatory filings and payer submissions.
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Desired Integrated Clinical Activities
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Infographic |
ISR Reports
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In Q1 2022, ISR surveyed 100 sponsors who outsource clinical logistics and asked them which activities they would like to source from a single service provider for a trial. Learn why clinical labeling, clinical supply chain management, and storage and distribution of clinical trial materials received the most votes.
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LabConnect's Scientific Operations Services
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Video |
LabConnect
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Today’s complex clinical trials require reliable and experienced technical and operational support throughout a study. Watch this video to see how LabConnect has supported their clients in critical functions by providing biospecimen managers and scientists to drive successful outcomes.
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Clinical Trial Material Distribution Services
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Product |
Ropack Pharma Solutions
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As your clinical material partner, we simplify – and accelerate – your clinical trials. From assistance with time-consuming international documentation through destruction following all regulatory protocols, RPS is your trusted clinical trial partner.
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