Choosing an eCOA Vendor for Clinical Trials

What are the characteristics of an effective eCOA offering?

In today’s fast-paced and competitive clinical research environment, data quality and speed are primary considerations for conducting effective and efficient clinical trials. For these reasons, many sponsors prefer to use electronic clinical outcome assessment (eCOA) solutions to capture data from clinicians, patients, and other trial participants.

By adopting an eCOA solution rather than pen-and-paper assessments, sponsors can achieve more accurate, secure, and efficient data collection, ultimately leading to more reliable study outcome measures and a smoother path to regulatory approval. We explore this topic in more detail in this paper.

However, selecting the right eCOA vendor is not always straight-forward, yet it is crucial for success.

Meeting the needs of modern clinical trials

To balance the needs of all clinical research stakeholders in today’s trials, an effective eCOA solution must meet many requirements of a pharmaceutical company or clinical research organization (CRO) evaluating eCOA vendors. These often include:

Technical Infrastructure & Security

• Data security regulation compliance (HIPAA, GDPR, 21 CFR Part 11)
• System uptime/reliability guarantees
• Data backup and disaster recovery capabilities
• Authentication and access control features
• Comprehensive, searchable audit trail
• Data encryption standards

Patient-Facing Features

• User interface intuitiveness and accessibility, and proven usability
• Proven suitability for diverse patient populations
• Alarms and reminders, and completion monitoring solutions, to aid on-time completion
• Built-in patient engagement features to guide the study journey
• Flexible hardware solutions, globally – BYOD and provisioned devices
• Multiple language capabilities
• Patient-facing helpdesk support in multiple languages
• Site-based and home-based completion options

Operational Capabilities

• Protocol design flexibility – fitting the needs of any study
• Credible in-house scientific and operational expertise
• Mature operational processes
• Established relationships with COA authors and license holders, with in-house license management capabilities
• Established processes with translation vendors, and in-house localization specialists
• Reliable implementation timeline estimates
• Robust logistics capabilities
• Integration with other eClinical systems (EDC, CTMS, etc.)
• Real-time data monitoring and visualization
• Suitable data export formats and options
• Robust, audit-trailed, DCF (data change) process

Implementation & Support

• Mature and transparent implementation methodology
• Experienced project management with established processes
• Training programs (site staff, patients, study team)
• Technical support availability (24/7 global support)
• Help desk capabilities, including patient and site access
• User acceptance testing (UAT) support

Regulatory Compliance

• Successful regulatory audit history
• Ability to support documentation for regulatory submissions
• Validation documentation
• Change control processes
• Full compliance with regulatory guidelines

Scalability & Flexibility

• Ability to implement and support multiple studies simultaneously
• Scale to transition from early phase to global phase III solutions
• Operational teams in the Sponsor/CRO’s timezone
• Rapid mid-study change implementation processes (e.g., Protocol amendments)
• Comprehensive, flexible capabilities to fully support all study designs

Signant’s eCOA Philosophy: The Four S’s

While many eClinical vendors offer an eCOA solution, few are resourced adequately to support these requirements throughout the full journey of the clinical research lifecycle from early-phase, local trials to pivotal multinational trials and on through regulatory submission.

As a global eCOA vendor to sponsors and CROs for nearly 30 years, we approach eCOA using our “Four S” framework in which each pillar addresses the requirements outlined above:

Solution
A robust eCOA technology solution is essential for successful implementation. It should meet all the needs of modern clinical trials without compromising study requirements. Signant SmartSignals^® eCOA is built from 25 years of experience across approximately 5,000 clinical trials, ensuring comprehensive features and capabilities for seamless study management.

Science
Scientific expertise is crucial for implementing eCOA that provides high-quality clinical evidence for regulatory submissions. Signant Health's dedicated science and medicine specialists support customers in ensuring optimal measurement strategies, designing the best-fit solutions for each study, and ensuring alignment with industry best practices. They assist with eCOA strategies, custom instrument design, and provide input on regulatory submissions.

Scale
Global scale is vital, especially for multinational pivotal trials. Having Signant project teams in your time zone facilitates efficient working. Global scale also applies to the ability to support multiple languages and localizations, deliver global device logistics, 24/7 multilingual support, having the operational capacity for parallel studies, and having robust infrastructure that meets the needs of regulatory bodies around the globe. Signant Health operates in over 135 countries, supports over 600 live eCOA studies, and has conducted the industry's largest BYOD study with over 47,000 participants.

Service
Excellent service is key to trouble-free eCOA implementation. This encompasses responsive staff, COA measure version selection and licensing management, streamlined translation processes, comprehensive logistics, multilingual helpdesk support, and experienced project teams following mature operational processes. Signant Health provides comprehensive service as an essential element of our eCOA offering.

Take the next step in modernizing your clinical trials:
Learn more - eCOA in Clinical Trials: A Complete Implementation Guide>