In this webinar, a team of expert panelists will answer key questions around the importance of clinical outcome assessment (COA) data in early phase trials. They’ll take a deep dive into frequently asked questions around effective COA collection strategies including the debate between paper vs. electronic diaries, electronic COA (eCOA) collection in decentralized and hybrid trials, regulatory requirements and guidance on patient-reported data, benefits of real-time data access and more!
Join the speakers as they explore issues which impact data quality and patient burden for biotechs, pharma and CROs.
Donna L. Reed, Consultant to the pharma industry
Donna is a graduate of Elizabethtown College (biology/chemistry medical technology) and has a York Hospital Med Tech certification. She had her first introduction to clinical research at the University of Penn women’s health in 1980 exploring biomarkers for tumor metastasis. After that Donna joined DuPont Life sciences, researching inflammation and virology as a Protein Chemist before joining their HIV research team (1985) which led to the discovery of new diagnostic tools. After moving to Geneva, Switzerland, in 1988 to launch HIV diagnostics in Europe, Middle East, Asia and Africa she developed rapid tests, ELISA and western blot products with a start-up company based in Singapore. From 1997-2000 Donna was a Strategic Account Manager for Covance Central Lab and joined PHT Corporation (eCOA) to expand their market into Europe where she worked closely with the product management and science teams to optimize solutions. She is now a consultant within the pharma industry.
Bryan McDowell, MSc, MBA, Vice President, eCOA Clinical Science & Consulting
In his role as VP, eCOA Science and Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug and device development programs. Bryan is a thought leader and recognized strategist and visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug and device development and life cycle management.
Kelly Dumais, PhD, Principal Scientific Advisor
Dr. Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient-reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
(Moderator) Chris Vogel, Executive Director, eCOA Solutions, Clario
Chris Vogel is an eClinical Solutions leader focused on helping improve the clinical research experience through patient-centered technology. For the past 16 years, he’s focused on evolving the role of eCOA within the clinical trial ecosystem and specializes in consulting on eCOA lifecycle and solution design. As Executive Director of eCOA Solutions, Chris and his team help sponsors and CROs review protocol requirements to determine the optimal way to collect key eCOA study endpoints taking into consideration regulatory and therapeutic area best practices on a global scale.
Who Should Attend?
Senior Professionals from Biotech, Pharma and CROs, including:
- Clinical Operations, Clinical Development, Clinical Research
- Clinical Scientists
- Regulatory Affairs
- Clinical Data Managers
- Clinical Drug Development
- Clinical Program/Project Manager
- Clinical Trial Lead
- Sr. Manager, Trial initiation
- Data Science
- Digital Health
- Digital Operations
What You Will Learn
- Understand the importance of capturing clinical outcome assessment (COA) data and what global regulators require
- Gain insight into the pitfalls with paper diaries and their impact on trial data quality, timelines and cost
- Realize the impact of electronic COA (eCOA) capture on data quality and patient burden
- Understand what a decentralized or hybrid trial is and how this impacts COA collection
- Understand why real-time data is valuable in early phase clinical trials
Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives. Through Trial Anywhere™, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clario’s global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.