Early-phase clinical trials, including First-in-Human (FIH) studies, represent pivotal milestones for emerging biotech and MedTech companies. Success during these initial stages not only sets the foundation for US Food and Drug Administration (FDA) approval but also ensures long-term commercial viability, including market access and payer reimbursement.
The path to achieving these objectives is often filled with challenges such as navigating complex regulatory requirements, designing trials that can accommodate future phases and implementing scalable clinical data management systems (CDMS)/electronic data capture systems (EDCS) to handle increasing volumes of data.
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The discussion will cover practical aspects of early-phase trial management, including common pitfalls that can delay or derail progress and how to proactively address them.
In this webinar, the expert speakers will guide the audience through key strategies for overcoming the most common hurdles encountered in early-phase clinical trials. They will provide insights into optimizing trial design for scalability, selecting technology solutions that support long-term growth and ensuring high standards of data quality across all phases.
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The attendees will also gain an understanding of how a robust approach to data management not only helps meet regulatory requirements but also improves operational efficiency, accelerates timelines and strengthens the case for payer reimbursement. The discussion will cover practical aspects of early-phase trial management, including common pitfalls that can delay or derail progress and how to proactively address them.
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The speakers will also share real-world examples of companies that have successfully navigated these early stages, including strategies they employed to achieve regulatory milestones and prepare for future trial phases. The panel will discuss how to choose the right CDMS/EDC features to support evolving needs and maintain data integrity, thus emphasizing the importance of adaptability in clinical research.
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Source – prweb
