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Innovation Meets Expertise: TRYAL's eCOA Solution

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.


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