Navigating Early-Phase Clinical Trials: Key Considerations for Emerging Biotech and MedTech

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. 

Speakers

Nicole Latimer, Chief Executive Officer, Medrio

Nicole Latimer is Medrio’s Chief Executive Officer. As CEO, Nicole carves out her time in three equally and critically important areas: studying the life sciences industry, making decisions about how Medrio can have a greater impact on that industry and then focusing on the best way to communicate those decisions to staff and customers.

She brings 25 years of impressive and broad-based healthcare experience, including stints at The Advisory Board Company (now part of Optum) and Deloitte Consulting, where she focused on population health management, health system growth strategies, patient and employee education and SaaS development and delivery.

Most recently, in her role as CEO of Staywell, she drove the company’s mission to be the premier provider of lifestyle risk management programs for the entire healthcare ecosystem, leveraging behavioral science as the foundation for improving health outcomes. She shines at redesigning processes, increasing efficiency and reducing costs.

Message Presenter

Kate Smith, MPH, Vice President, Clinical Affairs, Lumicell

Kate Smith is the Vice President of Clinical Affairs at Lumicell and has over 15 years of experience in leading clinical affairs teams in the cancer field, most prominently in breast and lung cancers contributing to the success of novel cancer diagnostic technologies becoming available to clinicians and patients.

Kate holds an MPH from Boston University with a focus in Epidemiology. Additionally, Kate has held the position of Clinical Instructor at Boston University’s School of Graduate Medical Sciences in the Healthcare Emergency Management Program teaching both Epidemiology and Intro to Public Health courses for over 10 years. Lastly, Kate is a Certified Clinical Research Professional (CCRP) by the Society of Clinical Research Associates. 

Message Presenter