Electronic Clinical Outcome Assessments (eCOAs) are exponentially used in clinical research and practice. Although regulatory agencies and working groups have published guidance on eCOA development, issues and ambiguities are still encountered in practice by the various stakeholders during the COA electronic migration process. It is therefore essential to provide clinicians, sponsors, and vendors with practical and up-to-date migration guidelines, which are specific to each COA and validated by their developers to secure the COA integrity and optimize the user's experience.

In this talk we will discuss:

• what is important to consider when implementing a COA to electronic format
• what challenges are faced in the digitization process
• how to streamline screen review and certification process

Attendees will learn about solutions to handle common and sometimes complex digitization issues. They will also get a demo of guidance included in the eBooklets to help with development of COA to electronic format.

Speakers:

Foteini Sakellaropoulou
Account Manager
Mapi Research Trust

Florent Campo-Paysaa
eCOA Project Lead
Mapi Research Trust

Electronic Clinical Outcome Assessments (eCOA) have emerged as a powerful tool for enhancing the quality and efficiency of clinical trials. This presentation offers a comprehensive exploration of full-service eCOA, detailing its critical role from protocol review to study closeout, while illuminating its significance across various therapeutic areas. Attendees will gain insights into the transformational impact of eCOA on trial design, globalization, patient engagement, data collection, and analysis, ensuring the highest levels of accuracy, reliability, and regulatory compliance. With real-world examples and case studies, we will showcase how eCOA streamlines clinical trials and empowers researchers to make data-driven decisions, ultimately bringing life-changing therapies to patients faster and more efficiently. Join us for a captivating journey through the future of clinical trials and discover how full-service eCOA is shaping the medical research landscape.

Speaker:

Kyle Hogan
President
Datacubed Health

• ALCOA+ principles
• Normalised data
• Remote Monitoring capability
• eCOA to fit around the participants life rather than be the participants life

Speaker:

Farrell Healion
Director, Global Clinical Solutions
AstraZeneca  

According to the Tufts Impact Report, 70% of investigative site staff believe conducting clinical trials have become increasingly difficult over the last five years. Staffing, study budgets, and protocol complexity are top challenges that are routinely noted. In addition, sites struggle with the implementation of new technologies and operating models, leveraging remote staff, and virtual facilities. 

To mitigate challenges, clinical sites must rethink how they operate and employ agile and resilient tools. An optimal combination of technologies with supplemental services that help accelerate manual processes is the key to transformational change in study start-up, efficient clinical trial conduct, and productive, satisfied sites.

In this webinar, Joe Dustin, VP/GM of eCOA and Annie Hesslewood, Site & Patient adoption lead at Medable will have an open discussion with a panel of sites and CRAs. The discussion will provide a candid assessment of the site perspective of how upcoming changes in the eCOA landscape can reduce burden on participants and sites to maximize the chance of success in clinical trials.

Key Learnings: 

• Perspectives and guidance for effective eCOA implementation
• Surprises that may occur when adopting eCOAs for use in clinical trials
• An introspective into site resource challenges
• Insights into how training and support can reduce operational barriers

Speakers:

Joe Dustin
VP/GM of eCOA
Medable

Annie Hesslewood
Patient & Site, Global Adoption Lead
Medable

Jimmy Bechtel
Vice President of Site Engagement
Society for Clinical Research Sites (SCRS)

Alisha Lutat
Patient & Site, Regional Adoption Lead
Medable

The session will provide detail on the activities, recent output and future interests of Critical Path Institute’s Electronic Clinical Outcomes Assessment (eCOA) Consortium, a pre-competitive neutral space for eCOA technology and allied service providers to progress the science of eCOA.  The eCOA Consortium includes amongst its membership the overwhelming majority of eCOA service providers, all of whom joined the consortium to collaborate and align on best practice and educational resources to benefit the clinical development community as a whole.  The eCOA Consortium is the only eCOA-centric collaborative entity in existence, and has generated a wealth of resources both independently and in collaboration with the sponsor companies within the Patient-Reported Outcomes (PRO) Consortium that will be illustrated in this session.

Speaker:

Scottie Kern
Executive Director, eCOA Consortium
Critical Path Institute 

• Consolidation of Patient Facing Capabilities (eCOA, Engagement, eConsent & DCT)
• Evolution of BYOD and Hybrid Modalities in eCOA Patient Data Acquisition
• Avenues to decrease build time and Localization

Speaker:

Lance Kupka
Director, Clinical Systems Design (EDC & IRT)
Clinical Data Strategy & Operations
AbbVie