Clinical Guest Contributors
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FDA Talks Help Cybin Advance Two Psychedelic Drugs Toward Approval
7/26/2024
Cybin CEO Doug Drysdale discusses regulatory considerations relating to the pursuit of two different psychedelic drugs and talks about trends in the larger psychedelic drug space.
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Another One For Ozempic? Investigator Recounts Trial For Chronic Kidney Disease
7/24/2024
Clinical Leader chatted with Richard E. Pratley about his positive experience working with Novo Nordisk on an Ozempic trial and the challenges of executing it amid the COVID-19 pandemic and changing standard-of-care landscape.
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Sites To Sponsors: Have A Little More Trust
7/24/2024
Atlas Clinical Research CEO Mark Scullion says trust should be the foundation of a proper site-sponsor relationship and posits that site networks are at an advantage to do just that.
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How Early Talks With The FDA Can Pave Your DTx Approval Pathway
7/22/2024
Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.
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From Data Chaos To Clarity: How To Modernize Clinical Trial Site Selection
7/19/2024
The Pistoia Alliance introduces the ClinOps Ontology Project, an effort to establish a common language agreed upon by stakeholders across the industry to improve and standardize data collection and streamline site selection.
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Extended GCP Training Is A "Must" For Cell And Gene Therapy Clinical Trials
7/18/2024
Cell and gene therapies (CGTs) carry specific challenges and risks, and so all parties need enhanced training to ensure patient safety, data quality, and Good Clinical Practice (GCP) and regulatory compliance.
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Understanding The Basics Of EU Clinical Trials With CTIS
7/17/2024
Discover how the EU's Clinical Trials Information System (CTIS) streamlines the process for evaluating and overseeing clinical trials.
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Why Sponsors Should Obsess Over Clinical Trial Oversight
7/16/2024
Just in Time GCP Founder and CEO Donna Dorozinsky explores the importance of clinical trial oversight and what to expect for the future of clinical trial oversight.
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What Clinical Trial Information Do VCs And Investors Actually Want?
7/15/2024
To prepare for conversations with investors, biotechs should know the “who,” the “why,” and the “when” of their clinical trial setup. Experts from LongeVC explain.
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How Clinical Research Can Be A Path To Clinical Care For Minority Health
7/12/2024
BJEConsultants Chief Quality Officer Courtney Shihabuddin, DNP discusses how clinical research can be a pathway to clinical care for minority populations, specifically exploring care for minority women with breast cancer.