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Tag: white paper

Quality

Planning for Quality in Medical Device Clinical Trials

Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional on-site monitoring to risk-based monitoring requires cross-functional collaboration and careful planning. Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively...

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Clinical Research: Phase 1 - Phase 4

Finding the Fast Track in Early-Phase Oncology Trials

Put yourself in this scenario: Your compound is a newly validated mutated receptor that is present in only a limited number of cancer patients, and there is no approved diagnostic test. Your product, an antibody-like molecule that inhibits the receptor’s activity, also stimulates a potent immune response. Further complicating things, much of the preclinical data...

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Consulting

Six Dosing and Safety Considerations in the Era of Emerging Therapies

Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies. Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies include: Using dose-finding trial designs...

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