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Clinical Outcome Assessments (COAs) are critical scientific tools used in clinical studies, disease treatment, and daily care. They help measure the impact of disease and treatment on patients’ quality of life as well as elevate the patient voice. Each COA is carefully calibrated through rigorous research, peer review, and target demographic testing. Because of their important role in collecting study data, they must comply with health authority requirements, developer guidance, copyright owner conditions of use, and technical and linguistic methodologies designed to ensure their safe and accurate application.
Understanding the major factors that influence the COA licensing process can empower individuals and teams to coordinate this task with ease and skill. In this webinar, attendees will learn the standard flow of activities for managing COA licensing, key considerations during study startup, and common challenges. They will review case examples and receive useful tips to help anticipate essential milestones. Attendees will leave this webinar with new strategies for alleviating operational complexity, saving time, and ensuring compliance with overseeing regulatory bodies and intellectual property owners.
Who should attend?
This webinar is designed for participants in the healthcare and life science industries who are responsible for implementing COAs in their clinical or research studies and who may not be fully familiar with the requirements, constraints and challenges around COA use:
- Healthcare professionals, clinical researchers planning to use or using COAs in their clinical research and practice.
- Pharmaceutical and bio-tech companies planning to use or using COAs in their research projects and clinical studies.
- Clinical Research Organizations (CROs), eCOA vendors and IT companies managing COA licensing for their clients.
- COA developers and copyright holders seeking advice on COA licensing process.
What you will learn
- Basics of COA copyright in the life sciences field.
- Pitfalls of COA licensing and mitigation plans to secure study timelines.
- Differences in licensing process for paper and electronic COA.
- Importance of interactions with COA developers.
- How to ensure the use of protocol-compliant COA versions.
Speakers
Janick Michel
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. 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 Mapi Research Trust experts through COA developers’ collaboration, scientific support, eCOA solutions and linguistic validation.
Julia Weissmueller
Julia has been managing COA licensing projects for a variety of pharma clients since 2016. Prior to joining the Mapi Research Trust, she spent over 13 years managing translation projects in the medical and other industries. She holds a Master in Translation Studies from Heidelberg University, Germany.
Marie-Pierre Emery
Marie-Pierre Emery has been working in the field of Clinical Outcome Assessments (COA) within Mapi Research Trust for 30 years. She currently uses her experience and her privileged relationship with numerous actors in the COA field to establish collaborative agreements with COA developers and copyright holders to further increase the dissemination and exponential use of COAs in clinical research and practice worldwide, for the ultimate benefit of the patients.