Platform

Data Aggregation, Rules Based Data Insights / Triggers and Notifications

The EMA platform aggregates multimodal data for in-depth review and analysis across different levels.

Levels of Data Aggregation

Data is reviewed at multiple levels, including:

Patient

Site

Country

Study Arm

Overall Study

Rules-Based Insights & Triggers

During configuration, study teams define rules that are codified during User Acceptance Testing (UAT). These rules trigger flags in two forms:

Notifications

Provide longitudinal & momentary insights at the site, rater, subject, and study level.

Alerts

Require immediate review and trigger an adjudication path.

Examples of alerts include:

Inclusion/exclusion criteria violations

Adverse Events of Special Interest (AESIs)

Unusual trends in ratings or scoring

Multimodal Data & Its Advantages

Flags are generated across multiple data modalities, leveraging insights from various sources and platforms.

The key benefits of structuring multimodal data within a purpose-built canonical environment include:

Data Collection and Gathering