eCOA

Signant Health's eCOA (SmartSignals) is an electronic Clinical Outcome Assessment platform designed to deliver reliable, high-quality patient-reported outcomes (PRO) and other COA data across clinical trials of any size or complexity. Built around patient-centered technology, the platform supports sponsors and sites in collecting accurate, submission-ready evidence — from early-phase local studies through large-scale multinational pivotal trials.

SmartSignals eCOA is purpose-built for life sciences organizations that need more than just technology. It combines a comprehensive digital platform with in-house scientific expertise, global operational infrastructure, and a deep eCOA instrument library to ensure studies are set up for regulatory success from protocol design through submission.

Four Core Pillars of eCOA Success

• Solution: A comprehensive technology platform supporting ePRO, complex ClinRO, and the reporting tools required by sponsors and sites — with no surprise capability gaps.
• Science: Over 50 full-time clinical and eCOA experts proactively guide and monitor studies from protocol design through regulatory submission, ensuring best practices are in place to generate reliable evidence.
• Service: End-to-end operational support including translation services, device provisioning and logistics, patient-facing local-language helpdesk, and implementation expertise for simple or complex studies in any indication and any time zone.
• Scale: An end-to-end platform with global project delivery infrastructure enabling seamless scaling from early-phase local trials to multinational pivotal trials.

Data Quality Standards

• Logical: Built-in logic checks and rules keep data clean throughout collection.
• Legible: Digital assessments eliminate the need to interpret handwritten responses.
• Attributable: Unique patient-specific credentials assign every entry to the correct patient.
• Accurate and Timely: Completion windows and time stamps guarantee data is collected at the required time points.

Key Platform Features and Capabilities

• In-House Scientific Experts: Clinical and scientific specialists implement and develop instruments according to established best practices.
• Complex ClinRO Support: The platform uniquely supports both ePRO and complex ClinRO assessments, making it suitable for any therapeutic indication.
• Extensive eCOA Instrument Library: A library of over 50 instruments commonly used in clinical trials, including standard scales for oncology and other therapy areas. Many instruments are pre-approved and pre-validated, eliminating additional author review or testing steps and saving time while ensuring quality.
• Computerized Adaptive Tests (CATs): Supports implementation of PROMIS CAT seamlessly alongside conventional PROMs, with more than 20 domains available including anxiety, depression, fatigue, sleep disturbance, pain interference, physical function, and social function.
• Robust Reporting: The interactive StudyIQ dashboard suite provides real-time data and insights across a wide range of study performance metrics.
• Scale Licensing and Management: Expert support for selecting, licensing, and managing clinical outcome assessment scales throughout the study lifecycle.
• Faster Study Builds: Intelligent automation technologies accelerate study builds and scale management, enabling up to 33% faster eCOA launch timelines.
• Flexible Deployment: Supports provisioned devices, web-based access, or patients' personal devices (BYOD) to suit varying study requirements.
• Global Logistics: Comprehensive device installation, inventory management, and international shipment capabilities ensure devices arrive ready on time in any country.
• 24/7 Helpdesk: Around-the-clock support for patients and sites in local languages, available whenever it is needed most.

Scientific Consulting and Regulatory Support

• Signant provides expert scientific consulting as an integral part of its eCOA offering, combining advanced technology with clinical expertise to set studies up for success.
• The team maintains credibility among instrument authors and license holders, helping navigate electronic implementations effectively.
• With a deep understanding of regulatory requirements, Signant's experts guide clients throughout the full clinical trial lifecycle to protect data quality and support submission readiness.

Associated Solutions and Services

• Language Management: Full study localization and linguistic validation services to ensure assessments are culturally and linguistically appropriate end to end.
• Scale and License Management: Simplified selection and management of appropriate clinical outcome assessments for each study.

Signant SmartSignals eCOA supports flexible deployment across provisioned devices, web platforms, and BYOD configurations, with global logistics infrastructure spanning multiple countries and time zones. The platform is designed to meet regulatory submission standards and is backed by scientific consulting expertise that spans protocol design, instrument implementation, and ongoing study monitoring.