inseption videos
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Engaging Patients & Investigators To Improve Trial Performance
8/2/2023
Patient organizations are important sources of information for trial protocol design. Jessica Powell, VP, clinical operations at Alto Neuroscience, talks about how small and midsize companies without a large commercial organization can engage patients and trial investigators to improve trial performance.
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FDA & ex-U.S. Product Approval
8/2/2023
Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.
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Biomarkers in Trial Protocol
8/2/2023
How should drug developers think about biomarkers in trial protocol design, particularly in neurodegenerative diseases? Jessica Powell, VP, clinical operations at Alto Neuroscience, shares her thoughts and experiences.
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The Model-Informed Drug Discovery and Development Program
8/2/2023
Drug developers should use a “model-informed drug discovery and development” program, which can help developers simplify the protocol design process, says Michael Krams, chief quantitative medicine officer at Exscientia.
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Phase 2 Clinical Trials: What to Include (And What To Leave Out)
8/2/2023
How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.
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Trial Protocol Design Do's And Don'ts
6/14/2023
Designing a clinical trial protocol that exhibits the value of a new drug is central to bringing innovative treatments to market. Listen in as experts share tips for ensuring no missteps go unnoticed.
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Patient Over Process: The inSeption Group Difference
1/18/2021
Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.