eCOA & Endpoint Surveillance

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Innovative technology and clinical expertise to optimize your clinical trial endpoints.

 

Our proprietary multi-modal eCOA solution integrates tablets, handhelds and wearables to electronically collect source documents, as well as capture audio, video, and clinician notes. We provide a collaborative platform in which raters are supported by their colleagues in maintaining the high inter-rater reliability achieved during training. Our focus is on corroborating key data elements while providing raters with timely, relevant, and culturally-competent feedback.

Endpoint surveillance is used as a standardized and empirically-based methodology for streamlining collection and improving the accuracy of outcome data by:

    • Diagnostic adjudication
    • Patient selection
    • Endpoint adjudication and monitoring
    • Ongoing monitoring of all data points in-study
    • Independent remote assessment

We use our extensive global network of clinical experts, anchored by clinical leads in each key region, to coordinate with the pools of expert trainers, reviewers, and independent raters, who are working with raters in their native language. The adaptive nature of this approach ensures that reviews are used only as needed as frequency and extent of the review can be modulated on a variety of risk factors at the trial, site and rater level. Raters who are struggling to translate key measurement principles to their context are provided with enhanced clinical decision support, while the sampling of successful raters continues at a safe, efficient level.

Our rater support starts with the first screening visit and, at the discretion of the sponsor, can range from reviewing screening visits only, all visits, or any fraction of visits based on a fixed formula or a risk assessment. Our operational and project management teams ensure that turnaround time for review and consensus discussions occur with raters promptly and efficiently.

About Our Technology

    • Multi-modal: tablet, handheld, ePRO, eDiary, biometric wearables, audio, video, notes
    • Proprietary, secure, 21 CFR Part 11 compliant
    • Site and rater approved

 

 

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