OVERVIEW
Improving your data quality
Ensure every data point counts. Clario’s eCOA Science experts help you capture high-quality, regulatory compliant data from the right participants, at the right time, in clinic or at home.
Partnering with eCOA Science helps you with:
Strategic guidance
Develop endpoint models, refine protocols, and select instruments that measure what truly matters.
User focused design
Build intuitive, accessible, and timely eDiary experiences that fit real-world use.
Validated insights
Utilize cognitive debriefing and usability testing to ensure comprehension and reduce study risk.
Expert training
Deliver targeted instruction that sets up participants, caregivers, and raters for success.
Proactive oversight
Enlist advanced analytics and central monitoring for early issue detection and actionable insights.
End-to-end support
Collaborate with a dedicated scientific advisor that guides you through every stage of the entire study lifecycle.
Our services
Protocol consultation and eCOA strategy development
Maximize label potential and reduce regulatory risk by building endpoint models and measurement frameworks guided by Clario’s dedicated eCOA science team.
Endpoint strategy and development
Build clear, evidence-based endpoints from the beginning to guide better decisions and streamline regulatory alignment.
Translate regulatory guidance into practical study decisions, align endpoints with FDA/EMA expectations, and prepare COA documentation that’s inspection-ready.
Instrument selection and protocol input
Our scientists help select the validated instruments most suitable for your population and study goals. Expert COA input, clear modality recommendations, and practical implementation guidance strengthens protocol clarity and site compliance.
eDiary design and modality consultation
Transform complex protocol requirements into intuitive eDiary experiences that boost compliance and accuracy, using best-practice design to deliver ALCOA-compliant, low-burden data across any device.
Cognitive Debriefing / Usability Testing (CD/UT)
Validate understanding and usability across your target population, resolving concerns early and producing evidence to support PRO acceptance.
Expert screen review
Conduct expert reviews that ensure COAs transitioning to eCOA or mixed modes remain accurate, compliant, and comparable.
Study start-up, conduct, and close-out
Drive confident, data-driven decisions throughout your study with comprehensive training, independent review, and advanced real-time monitoring.
Participant and caregiver training
Strengthen engagement and data reliability through clear, timely eCOA training that improves reporting accuracy and reduces variability.
Rater training
Ensure consistent, reliable clinician-reported measures across sites with certified training that standardizes scoring, builds skill through scenario practice, and maintains audit-ready records.
Independent rating
Employ blinded clinicians for virtual endpoint assessments to centralize expertise, reduce site burden, improve signal detection, and keep your trial on schedule.
Central Monitoring (CM) – Central review
Maintain consistent scoring and regulatory confidence with continuous review, early drift detection, and proactive remediation across raters and sites.
Advanced Analytics
Gain real-time insights into clinical and operational trends across sites and studies to drive faster, data-based decisions and meet regulatory expectations for data monitoring.
Speak with our science team to see how we can help you improve your data
eCOA Science Team
eCOA Science is a highly experienced team of experts with expertise across all therapeutic areas, including industry-recognized KOLs and physicians. We apply scientific rigor to inform recommendations on safety, quality and efficacy measurements, as well as patient burden and quality of life, while enhancing patient accessibility.
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Kelly Dumais, Ph.D.
Senior Director and Global Head of eCOA Science and Consulting
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Lorie Scrabis Yaccino
Director, Scientific Operations, Clinical Science and Consulting
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Laura Khurana, M.P.H.
Senior Principal Scientific Advisor
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Prateek Verma, M.D.
Director, eCOA Science and Consulting