Over the past two and a half decades, the landscape of electronic Clinical Outcome Assessments (eCOA) has undergone significant evolution. Best practices have emerged and coalesced to make it appear easier to build and deploy eCOA solutions than ever before. However, amidst the influx of new market entrants, challenges remain in striking the perfect balance between innovation and reliable execution.
Built by pioneers in electronic participant data collection with a deep understanding of study team, site and participant workflows, TRYAL has created a comprehensive, regulatory-compliant eCOA platform that is able to deliver innovation without compromising execution.
Reliable eCOA Functionality
TRYAL, using decades of experience and best practices, has created a mature eCOA software and service offering that helps ensure eCOA implementations are delivered according to plan.
In order to execute in a consistent, regulatory compliant, and repeatable way, a number of features and functionalities are incorporated into products and processes:
Real-time Data Capture & Participant Engagement
Ability to configure a wide range of assessment types, complex branching logic, multimedia elements
Configurable schedules for alerts/alarms that can be easily changed & deployed mid-study
Customizable time windows for compliant data entry
Text, email, and native app notifications
Built-in participant-to-site televisit and chat functionality
Standard and customizable reports at the study, site, and participant level
Open API and file exports for seamless integration with EDC and other systems
Online and offline capture via native IOS/Android apps or web browser
In-App time zone switching based on device location
Services & Support
Fully internationalized platform, supporting 100+ languages
24/7 global help desk support
Support for BYOD, provisioned devices, or hybrid models
Established partnerships with eCOA validation, licensing and translation vendors
One assigned project manager & team of experts focused on your protocol
Comprehensive training materials for sites and participants
Flexibility to make study- or site-based changes quickly throughout the study lifecycle (visit dates, site changes, etc.)
Passive, automatic updates to eCOA configuration without need for app upgrade
Single sign-on for sites & study team (eConsent, eCOA, & Home Healthcare)
Data Privacy and Regulatory Compliance
21 CFR Part 11, GDPR, & HIPAA compliant
TRYAL’s Quality Management System is audit-ready and adheres to global regulatory guidelines
Authentication and study data encryption at rest and in-flight
Full audit trail and compliance dashboard
Innovation in Implementation and Delivery
Historically, eCOA build timelines for new questionnaires have a very long development runway. Add in validation and translations, and timelines can get extended even further, causing a lack of transparency and frustration for the study teams trying to meet FPI.
TRYAL eCOA boasts a streamlined process that sets a new standard for efficiency and precision.
Using TRYAL’s proprietary context engine and a variety of AI models, TRYAL Accelerator analyzes a protocol, automatically identifies instruments and licensing authority, and matches them to a pre-built library. This approach drives efficiency in the initial steps needed for the eCOA configuration process. For instruments that are not yet in the pre-built instrument library, study teams don’t have to wait. TRYAL’s no-code, visual configuration interface allows study teams to preview a prototype of eCOA questionnaires at Project Kickoff, rather than at UAT. TRYAL eCOA represents the intersection of innovation and experience for electronic Clinical Outcome Assessments. With unmatched delivery capabilities, real-time data capture and participant communication, and unwavering commitment to regulatory compliance, TRYAL empowers clinical study teams to navigate the complexities of clinical trials with confidence and efficiency.
Ready to enhance your clinical research? Contact our team at info@tryalclinical.com or visit www.tryalclinical.com/ecoa to learn more.