Clinical Guest Contributors
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Whole-Body MRI Biomarkers Unlock A Fuller Picture In Neuromuscular Trials
10/15/2025
Discover the utility and promise of whole-body MRIs a digital biomarkers in neuromuscular clinical trials.
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Trends In Rare Disease Trials: Evaluating Trial Types' Pros, Cons, And Adoption Rates
10/14/2025
In the second article of the series, Beroe Inc. Lead Analyst Sapna Rani provides a comprehensive evaluation of leading trial types for rare disease development and compares adoption rates, design-specific trade-offs, and practical selection criteria.
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Trends In Rare Disease Trials: Trial Designs, Challenges, And Regulatory Progress
10/13/2025
Beroe Inc. Lead Analyst Sapna Rani unpacks the evolution of trial design types in rare disease research, analyzes ongoing challenges, and examines how regulatory support is enabling innovation in part one of this three-part series.
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How Enveric Biosciences Is Prepping For Its First IND
10/10/2025
Enveric Biosciences CEO Joseph Tucker, Ph.D., discusses how the team is finalizing IND-enabling studies, leveraging both in-house expertise and trusted external partners.
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Oncology PI Shares Lessons Learned And Successes Working With Basic Scientists
10/9/2025
Ranee Mehra, MD, shares her successes and discusses how they shape her approach to future research, as well as details the importance of working closely with basic scientists.
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Post-Trial Access: Compliance Lessons Hidden In Plain Sight
10/8/2025
What happens when the trial ends and the investigational product is no longer available? Edye T. Edens, JD, MA, CIP, CCRP, talks through the answer.
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What Sites Wish Tech Vendors (And Sponsors) Heard At SCDM But Probably Didn't
10/8/2025
During a Society for Clinical Data Management (SCDM) panel discussion, three site-side representatives discussed the challenges clinical research coordinators have executing their clinical duties amid increasingly complex data entry demands.
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SCDM 2025: Practical Advice From Global Regulators — Including The FDA
10/6/2025
Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.
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Mastering The Monitoring Visit: Key Tips For Site Success
10/6/2025
The ACRP Atlanta Chapter recently hosted a Lunch-n-Learn session on “Mastering the Monitoring Visit: Key Tips for Site Success.” The conversation highlighted the shared goal of CRAs and CRCs: ensuring compliance, protecting data integrity, and making monitoring visits a collaborative — not adversarial — experience.
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Import Product Specifications And Drug Registration Testing For China
10/6/2025
This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).