Eligibility Solution

Clario's Eligibility Solution is a cloud-based platform designed to centralize and manage participant screening and eligibility criteria for clinical trials. It is intended for sponsors, clinical research teams, and site staff who need to collect, track, and review participant data across multiple sites and regions with full transparency into eligibility status.

The platform replaces manual processes and paper-based or spreadsheet tracking systems with customized, automated workflows that support the full screening lifecycle, from initial data collection through enrollment decisions.

Custom Workflows and Screening Efficiency

• Workflows can be customized by country or region to simplify case flow administration, and can be configured as simple or complex, single or straight-line, and include concurrent reviews to reduce time in the screening process.
• Role-specific permissions restrict worklist access so that each stakeholder remains focused on their relevant tasks, supporting enrollment goal management.
• The user interface supports language localization, allowing team members to screen patients in their local language and apply region-specific eligibility criteria.
• Customizable dashboards provide sponsors and team members with real-time global metrics and reporting for performance monitoring.

Centralized Cloud-Based Tracking

• Eliminates manual touchpoints and spreadsheets by harmonizing data from multiple sources into a single platform, enabling tracking of all participants and sites in one place.
• Provides a central repository for inclusion and exclusion criteria data, with built-in data verification to reduce errors and support full review of enrollees and required information.
• Data can be entered from anywhere in the world and accessed by all approved stakeholders, reducing extraneous data transmission, unnecessary communication channels, and time to decision.
• Supports transition away from paper-based or legacy tracking systems to a global, cloud-based infrastructure.

Compliance, Transparency, and Audit Support

• The platform is compliant with 21 CFR Part 11 and EU GDPR, tracking all de-identification actions in an unalterable audit trail that provides complete traceability of the decision chain, including site-level and external data sources.
• Custom reporting allows stakeholders to define the content of their reports, covering questions such as site performance, current enrollment numbers, and inclusion/exclusion criteria profiles across sites.
• An image repository supports compliant storage and sharing of 21 CFR Part 11 and GDPR-compliant images from any device, anywhere in the world, for use in future clinical trial projects or audits, with retention for up to 25 years.

Support

• A multilingual customer support team is available 24/7/365 via chat, email, or phone to assist users globally.

The Eligibility Solution is positioned as part of Clario's Trial Enablement offering, targeting clinical trial teams that require a configurable, compliant, and globally accessible platform for participant screening and eligibility management.