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, M.S., J.D.
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
FAQs
What are Clario eCOA’s Science Services, and how do they support clinical trials?
Clario eCOA’s Science Services provide expert scientific guidance and consultancy to help pharmaceutical, biotech, and CRO partners design and execute high-quality, patient-centered clinical trials.
With these services, our eCOA Science team supports you from early protocol development through study close-out, help you capture reliable, regulatory-compliant data while minimizing patient burden. We provide protocol consultation and eCOA strategy development, including endpoints and instruments, eDiary design and cognitive debriefing and usability testing. At study start up, we provide participant and rater training and throughout the study lifecycle we help you maintain study oversight with advanced analytics, independent rating/review and central monitoring.
How does Clario help improve data quality and regulatory compliance in eCOA studies?
Clario’s eCOA Science experts enable accurate, reliable, and regulatory compliant data capture. We do this by:
- Developing evidence-based endpoint models and measurement frameworks.
- Selecting validated instruments most suitable for your study population.
- Providing clear, consistent protocol input aligned with FDA/EMA expectations.
- Conducting cognitive debriefing and usability testing to validate patient comprehension of the PRO measure and measurement device, and hence reduce study risk.
- Offering proactive oversight with advanced analytics, independent rating/review and central monitoring for early issue detection and actionable insights.
What makes Clario’s eCOA design and implementation user-focused?
Our approach centers on building intuitive, accessible, and timely eDiary experiences that fit real-world use. We transform complex protocol requirements into easy-to-use digital tools, so that participants, caregivers and raters can accurately and efficiently report data. Usability testing and cognitive debriefing are integral to our process, helping users understand and effectively use the eCOA solutions, regardless of device or setting.
How does Clario support training for study participants, caregivers and raters?
Clario delivers targeted, expert-led training to all study stakeholders:
- Participants and caregivers receive clear, timely instruction to improve engagement and reporting accuracy.
- Raters benefit from certified training that standardizes scoring, builds skills through scenario practice, and maintains audit-ready records.
- Our training programs are designed to reduce variability, improve motivation, enhance data reliability, and set everyone up for success from study start-up through close-out.
What ongoing support and monitoring does Clario provide during a clinical study?
Clario offers end-to-end support with a dedicated scientific advisor guiding you through every stage of your study. Our services include:
- Central monitoring and independent review to maintain consistent scoring and regulatory confidence.
- Advanced analytics for real-time insights into clinical and operational trends.
- Early detection of data drift or site issues, with proactive remediation to protect data integrity.
- Independent rating by blinded clinicians for virtual endpoint assessments, reducing site burden and improving signal detection.