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
Bryan Terry, Senior Data Manager, Inozyme Pharma
Dr. Bryan Terry is the Senior Data Manager at Inozyme Pharma, a clinical-stage biotech company located in Boston, Massachusetts. At Inozyme Pharma, Bryan is responsible for all aspects of data management, including electronic data capture selection and design, data management processes, regulatory compliance, and data delivery to support clinical trials and regulatory submissions. Additionally, Bryan oversees multiple vendors supporting Inozyme Pharma’s clinical trials.
Bryan is a highly skilled data manager with more than 20 years of experience in biotechnology companies, pharmaceutical companies, clinical research organizations, and academic institutions. He earned his Ph.D. in Research Methodology from the University of Florida. Bryan is a lifelong learner who seeks to expand his knowledge of the industry daily. Outside of work, Bryan is an avid golfer who enjoys traveling with his wife and two daughters.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Clinical Operations and Data Management Leaders
- Regulatory affairs professionals/Product development
- Procurement Decision-Makers
- IT Executives
- Principal Investigators and Trial Managers
- CROs and consutants assisting biotech and medtech companies
What You Will Learn
Attendees will learn about:
- Best practices for designing and scaling FIH and early-phase studies
- Why maintaining data integrity is critical for trial success and regulatory approval
- Key features of CDMS/EDC solutions that support evolving trial needs
- Navigating complex regulatory requirements while streamlining operations
Xtalks Partner
Medrio
Trusted by sponsors, CROs and sites worldwide, Medrio aims to improve 100 million lives through faster, more efficient, and secure clinical trials. With almost two decades of experience, Medrio delivers proven, scalable solutions, unrivaled customer support, and guidance to the industry’s leading innovators, including pharmaceutical, biotech, medical device, diagnostics and more. The company’s suite of solutions, including CDMS/EDC, eCOA/ePRO, eConsent and RTSM, enables the capture of quality clinical trial data while optimizing workflows for regulatory readiness. Experience the power of Medrio and realize the full potential of your clinical operations and outcomes – visit www.medrio.com.
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