Keep eCOA Off the Critical Path of Clinical Trial Startup

In today’s patient-driven and competitive drug development landscape, healthcare organizations and related clinical studies cannot succeed without active patient insight through clinical outcome assessments (COAs). There is a growing need for the life science industry to collaborate and take a strategic approach on the patient perspective, by seamlessly incorporating COA in trials without the usual setbacks like timeline delays and increasing health authorities’ requirements. It is time to discuss how organizations can keep electronic clinical outcome assessment (eCOA) off the critical path.

In this webinar, the featured speakers will help attendees achieve study objectives and critical timelines, by providing guidance on how to optimize and carefully manage COAs from initial risk assessment to full implementation.

Discussion topics include:

• Introduction to different types of COAs (different types of existing scales), general process and requirements for COA use in clinical studies
• Understand the main triggers and factors that cause eCOA implementation to end up on the critical path
• Understand how an end-to-end approach to eCOA implementation minimizes the risk of getting on the critical path

Join the speakers in understanding how to successfully plan and implement COA use with an end-to-end approach in clinical trial startup, from COA licensing, translation and electronic versions (eCOA).

Speakers

Brian Lillis, Director, Clinical Outcomes Technology, ICON

Brian has over 13 years’ experience in the development of site and patient facing eClinical Technology solutions. He has a broad range of experience across product development, operations and solution architecture. In this current role, he oversees the implementation of eCOA on ICON trials and is currently focused on how to streamline the eCOA implementation process across all stakeholders to ensure it does not become the critical path in clinical trial start up. Brian holds a PhD from University College Cork, Ireland.

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Hinna Rehman, Manager, Clinical Outcomes Technology, ICON

Hinna has a background in neuroscience with an MSc in clinical neuroscience and has been in the eCOA space for over seven years. Coming from a vendor background, Hinna has previous project management experience with vendors Signant Health and more recently Medidata. Hinna has been at ICON for almost two years. In her current role, Hinna now manages a team of startup project managers within the Clinical Outcomes Technology team to ensure seamless eCOA implementation on ICON trials.

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Christelle Giroudet, Account Manager, Language Services, Patient Centred Sciences, ICON

Christelle has been working in the field of clinical outcome assessments for clinical research for over 25 years. She has extensive experience in her various roles in project management, proposal development and commercial activities for linguistic validation projects and is a co-author of the Linguistic Validation Manual for Health Outcomes Assessments (2004, 2012). She developed her understanding of the broader COA domain through her collaboration with global health outcomes teams and Mapi Research Trust. In recent years, her activities within ICON’s Patient Centered Sciences involved coordinating COA-related services needed for clinical studies and liaising between clinical teams and internal functional groups dedicated to services around COAs. In this context, she gained an insight into the intricacies and constraints of the use of COAs in clinical studies. Ms. Giroudet is a translator by training and holds a postgraduate degree in life science translation and writing from the Lyon 2 University in France.

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Janick Michel, Director, Patient Centred Sciences, Client Services, Mapi Research Trust

Janick has broad experience in clinical and post-marketing studies spanning over 20 years. She has dedicated the past 15 years to patient centered services and direct-to-patient contact aiming to facilitate patients’ journey and experience in clinical research. This includes strategies for patient recruitment, retention and multilingual/multimedia PROs data collection for global Phase II to post-marketing programs across multiple therapeutic areas. In her current role within Mapi Research Trust, she is responsible for the global client services team including successful delivery to clients for COA distribution and licenses, business development and strategic initiatives in collaboration with other Patient Centered Sciences and Mapi Trust experts through authors collaboration, scientific support, eCOAs services and linguistic validation. Ms. Michel holds a postgraduate degree of international communication and translation in health sciences from the Lyon 2 University, France.

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