Electronic Clinical Outcome Assessments (eCOA)


Electronic Clinical Outcome Assessments (eCOA)Accurate patient data does more than support claims, it supports the work of your entire organisation

Whether needed to support pre-approval endpoint acquisition, or for payers requiring post-approval proof and value for treatment and patient results, our innovative technology provides access to the high-quality patient metrics you need, in a secure and validated environment.

Bring your own device

We offer a convenient bring-your-own-device (BYOD) solution to patient diaries and clinical outcome assessments via mobile, tablet, voice or web access. This “device agnostic” approach alleviates the patient and sponsor burden of provisioning and managing additional hardware.

Our leading-edge technology affords the ability to send notifications across all modalities (phone, text, SMS messages and email) to remind patients when to take their medicine, complete a diary, and take part in other critical study activities.

Additional features:

  • Patient compliance and engagement
    Patients can conveniently use their own devices to access and participate in clinical trials, using secure and compliant credentials.

 

  • Integrated platforms and state of the art technology (IXRS®)
    A central web portal for sponsors and sites to manage and coordinate clinical trial & patient management, eCOA & patient reminders are available as a stand-alone solution or as part of a shared architecture in the IXRS® platform.

 

  • Patient preferences
    An intuitive web portal can be utilised to maintain current patient information, featuring access to diary details and contact information.

 

  • Data integration and accuracy
    Data is captured and stored in the cloud, enabling you on-demand access, while also giving the option of exporting for any IT or reporting requirements.

 

  • Real-time data monitoring
    By accessing the business intelligence engine, you can view actionable  dashboards with drill down reporting capabilities at a study, site or patient level.

 

In addition to offering world-class technology solutions for patient reported outcomes, we are committed to advancing their quality and overall adoption. This is achieved through leadership and subject matter expertise in the Critical Path Institute’s ePRO Consortium of which we are a member.

Electronic Clinical Outcome Assessments (eCOA)


More Details

eCOA Features
eCOA Reporting
Statistical & Psychometrical Services for eCOA
eCOA Features

eCOA Features

  • Shared architecture with IXRS®
  • Patient Reported Outcomes and Validated Instruments for clinical trial endpoints
  • eDiaries and Quality of Life Assessments (QoL) for Phases IIIB and IV
  • Built-in data checks to ensure data accuracy
  • Biostatistical and psychometric testing support for eCOA studies
  • Multi-lingual capabilities to support global trials

eCOA Reporting

  • Real-time access to patient outcomes and clinical events
  • Alerting and monitoring to support any metric within your protocol
  • Standard and customised reports available
  • Integration with all data management systems including EDC, CTMS and other data systems

Statistical & Psychometrical Services for eCOA

Our in-house eCOA team of experts will assist in all stages of your clinical trial by:

  • Delivering professional consultation to identify the most favorable measurement strategies for your clinical trial: population, endpoints and minimal clinically important difference (MCID)
  • Offering literature searches to assist in the use of Quality of Life and other standardised questionnaires
  • Evaluating validity and historical usage of selected measurement scales
  • Providing the author, contact, or copyright holder details of the measurement scale to gain permissions for use
  • Offering psychometric testing and validation studies for conversion of paper instruments to electronic use, (e.g., phone, web)
  • Incorporating supporting information in regulatory submissions
  • Designing customised ePRO reports



More Details

eCOA Features
eCOA Reporting
Statistical & Psychometrical Services for eCOA
eCOA Features

eCOA Features

  • Shared architecture with IXRS®
  • Patient Reported Outcomes and Validated Instruments for clinical trial endpoints
  • eDiaries and Quality of Life Assessments (QoL) for Phases IIIB and IV
  • Built-in data checks to ensure data accuracy
  • Biostatistical and psychometric testing support for eCOA studies
  • Multi-lingual capabilities to support global trials

eCOA Reporting

  • Real-time access to patient outcomes and clinical events
  • Alerting and monitoring to support any metric within your protocol
  • Standard and customised reports available
  • Integration with all data management systems including EDC, CTMS and other data systems

Statistical & Psychometrical Services for eCOA

Our in-house eCOA team of experts will assist in all stages of your clinical trial by:

  • Delivering professional consultation to identify the most favorable measurement strategies for your clinical trial: population, endpoints and minimal clinically important difference (MCID)
  • Offering literature searches to assist in the use of Quality of Life and other standardised questionnaires
  • Evaluating validity and historical usage of selected measurement scales
  • Providing the author, contact, or copyright holder details of the measurement scale to gain permissions for use
  • Offering psychometric testing and validation studies for conversion of paper instruments to electronic use, (e.g., phone, web)
  • Incorporating supporting information in regulatory submissions
  • Designing customised ePRO reports


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