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.
In this webinar we will outline how to optimise and carefully manage COAs using an end-to-end approach - from initial risk assessment to full implementation.
Discussion topics include:
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Introduction to different types of COAs (different types of existing scales), general process and requirements for COA use in clinical studies
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How to recognise the main triggers and factors that cause electronic clinical outcome assessment (eCOA) implementation to end up on the critical path
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Understand how an end-to-end approach to eCOA implementation minimizes the risk of getting on the critical path
Speakers:
Brian Lillis
Director, Clinical Outcomes Technology, ICON
Brian has over 13 years of 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 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.
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 7 years. Her previous project management experience has been with vendors Signant Health and more recently Medidata. In her current role, Hinna manages a team of startup project managers within the Clinical Outcomes Technology team to ensure seamless eCOA implementation on ICON trials.
Christelle Giroudet
Account Manager, Language Services, Patient Centred Sciences, ICON
Christelle has been working in the field of Clinical Outcomes 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). Her activities within ICON’s Patient Centered Sciences involve coordinating COA-related services needed for clinical studies and liaising between clinical teams and internal functional groups dedicated to services around COAs.
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., with the last 15 years in the areas of 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 she is responsible for the global Client Services team.
Target audience
This webinar is designed for life science industry professionals in the following areas who implement COAs across all clinical trial phases and who need to be familiar with the requirements, constraints and challenges around eCOA use in clinical studies:
- Global Clinical Program Management
- Global Health Economics, Outcomes Research
- COA and Digital Implementation
- Patient Centered Outcomes
- Clinical Research Operations
- COA Managers
- Global Market Access
- PRO Development & Implementation
- Vendor Management professionals who oversee COA/eCOA and Linguistic Validation