SUMMA

SUMMA is a self-service Real-World Evidence (RWE) platform developed by Precision Digital Health. It is designed for companies conducting clinical research, offering automation tools to help transform research workflows. SUMMA is a configurable solution that supports the FDA's directive to use real-world data (RWD) to improve efficiencies in clinical research, drug development, and health-related outcomes.

The platform integrates large, disparate real-world data sources into a unified research environment. Supported data sources include electronic health records (EHR), historical clinical trials data, EDC systems, eCOA, ePRO, claims data, disease registries, laboratory data, medical devices, wearables, and Health IoT devices.

Platform Modules and Capabilities

• eConsent: Supports compliant subject e-signatures and co-signature workflows.
• Forms and Surveys: Provides configurable questions and workflows to capture information directly from patients.
• Sensors and Medical Devices: Integrates medical devices into any trial model to capture new data sources.
• Alerts: Delivers automated notifications to system users for key activities, supporting compliance and data quality.
• Task Management: Provides a clinical staff task inbox to prioritize and push workflow activities to clinical users.
• Visit Schedule: Allows configuration, management, and alerting of trial activities through a schedule of activities.
• Enrollment Module: Handles integration for subject enrollment events and associated data.
• Lab Module: Supports integrated lab ordering, tracking, and results delivery, with results sent directly to patients and other system users.
• EDC Integration: Connects to third-party Electronic Data Capture systems to integrate trial data.
• Payment Module: Tracks participant payments across their lifecycle, including financial tracking and reconciliation.
• Dashboards and Reports: Offers role-based and configurable reports and dashboards.
• Exports and API: Supports data extracts and analytical datasets delivered in multiple formats, including CDISC, HL7, JSON, and CSV.

Precision Digital Health holds an AWS Partnership and participates in the Data Privacy Framework (DPF). The company is headquartered in Irvine, California.