eCOA technology is transforming the clinical trial experience for patients, clinicians, caregivers and sites by helping sponsors improve data collection, increase data quality and accelerate development programmes.
eCOAs (electronic clinical outcome assessments) support primary, secondary and exploratory endpoint data and offer many significant advantages over paper-based assessments. eCOAs are rapidly becoming the industry preferred method of COA data collection. Sponsors are harnessing the potential of digital technologies such as smartphones, tablets, wearables, interactive voice response systems, and device applications to help clinicians, patients and their caregivers complete their reporting by:
- Improving compliance and reducing patient burden
- Eliminating inconsistencies seen in a paperbased approaches (missing, illegible, or late entries) to improve data accuracy
- Enforcing a time window for data collection (avoiding the “parking lot effect”)
- Making data available for review in real time
- Increasing patients’ willingness to answer sensitive questions
eCOA development plan
The eCOA development cycle involves a number of complex services, multiple stakeholders and interdependent deliverables that must come together seamlessly in a prescribed sequence of events. Having a carefully considered eCOA implementation plan and working with the right partners can eliminate unwelcome surprises and mitigate the risk of delaying study start up. A single project plan developed, coordinated and managed by an experienced team is critical to successful eCOA development.
End-to-end eCOA implementation
ICON delivers an end-to-end eCOA implementation solution designed as a fully integrated and flexible full-service offering from protocol design to study closeout:
- COA strategy - our consultancy service Patient Centred Outcomes supports the design and review of a COA endpoint strategy.
- COA licensing, early COA assessment, and eCOA Services - direct access to 700+ COAs exclusively distributed by Mapi Research Trust on behalf of COA developers AND support to identify and mitigate any operational risks related to COA/eCOA implementation.
- Linguistic Validation of eCOAs- Language Services provides in-house translation services ensuring the linguistic, cultural and conceptual equivalent to paper versions.
- Digitise and deploy eCOA platform - powered by ICON Digital Platform using a library of pre-approved digital versions of COAs for reduced project timelines.
- User acceptance testing - robust testing is performed by an internal team with strong UAT experience and expertise across all of the major eCOA vendor platforms to verify eCOA system design.