In this free webinar, learn best practices for designing and scaling First-in-Human (FIH) and early-phase studies. Attendees will discover why maintaining data integrity is critical for trial success and regulatory approval. The featured speakers will discuss key features of clinical data management systems (CDMS)/electronic data capture (EDC) solutions that support evolving trial needs. The speakers will also discuss navigating complex regulatory requirements while streamlining operations.
TORONTO, Nov. 11, 2024 /PRNewswire-PRWeb/ -- 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.
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.
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.
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.
Register for this webinar today to accelerate the path to approval and ensure that early-phase trials set the stage for future growth and commercial success.
Join Nicole Latimer, Chief Executive Officer, Medrio; Kate Smith, MPH, Vice President, Clinical Affairs, Lumicell; and Bryan Terry, Senior Data Manager, Inozyme Pharma for the live webinar on Tuesday, December 3, 2024, at 2pm EST (11am PST).
For more information, or to register for this event, visit Navigating Early-Phase Clinical Trials: Key Considerations for Emerging Biotech and MedTech.
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