Electronic Clinical Outcomes Assessment (eCOA)


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Electronic Clinical Outcomes Assessment (eCOA)

eCOAs (electronic Clinical Outcome Assessments), including ePROs (electronic Patient Reported Outcomes) and electronic ClinROs (Clinician Reported Outcomes) and ObsROs (Observer Reported Outcomes), are used increasingly in the collection of patient data as part of clinical trials and observational studies. ICON’s eCOA practice is a market leader in electronic observational measure development and validation. Our UK and US teams bring together opinion-leading scientific expertise, knowledge of marketplace and regulatory landscapes, together with consultancy skills and deep understanding of client needs.

Case study thumbnailCase Study: Wearables for a large multinational trial Read the Case Study

We have conducted a number of development and validation studies and provide the following services:

  • Strategic advice and trial design
  • eCOA development
  • Migrating COAs to eCOA format
  • Cognitive debriefing and usability testing
  • Exploring patient views of technology platforms
  • Mobile phone based applications
  • Equivalence studies
  • Psychometric validation studies
  • Integrated linguistic validation and eCOA cognitive debriefing studies

We are able to conduct validation studies across a broad range of national markets to meet regulatory and/or scientific publication standards. We are also able to integrate eCOA validation, translation and linguistic validation processes, achieving overall time and cost savings for our clients.

Our team contributes to the scientific advancement of eCOA services; ICON’s Willie Muehlhausen is the Vice Director of the ePRO Consortium within the Critical Path Institute, a group charged with developing best practices and standards within the eCOA industry. This group has developed guidance for PRO developers and vendors.