inseption videos
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A Deeper Dive On Mitigating Financial Risk Before Selecting A Vendor
1/23/2024
In part two of this webinar series, presenters focus on avoiding potential risks such as unexpected budget changes and unplanned change orders that could jeopardize the success of a clinical trial.
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Practical Applications Of ICH E6(R3): What Do We Need To DO?
12/14/2023
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
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Mitigating Financial Risk Before Selecting An Outsourcing Vendor
9/25/2023
Gain insight into the significance of meticulous contract examination when choosing an outsourcing partner.
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Trial Control Arms - Best Practices
8/2/2023
Mitchell Katz, SVP, global clinical operations, has “been there, done that,” when it comes to making decisions about trial control arms, which comparator to use, or the number of patients needed in a first-in-class drug development program. Katz shares his process and thinking here.
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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.