All trial modalities captured across approved sources.
Platform
One globally validated technology platform to capture, standardize, analyze and action multimodal clinical trial data
EMAW provides sponsor partners important competitive advantages, including: speed to
study activation and database lock; better subject selection; increased site and rater quality;
precision insights; and mitigation of study execution cost and risk.
Legacy eCOA and
digital biomarker platforms trying to integrate multiple data modalities using different
technologies have to customize their platform build for each study, which is why it takes them twice
as long to get into production than the EMA Wellness platform. The complexity of the legacy company
data journey also applies to data extracts and access, often precluding real-time insights and
AI-based derivative data and unnecessarily delaying database lock.
Newer technology
platforms have not been validated in global phase 3 programs, and do not have the quality management
systems or CNS domain expertise required of a data platform collecting primary
endpoints.
The EMAW platform was built to be fully web-based, intentionally agnostic to
device or operating system. This mitigates site and patient burden and while providing access to
eCOA, ecological momentary assessment, audio/video, sensor and wearable, passively collected health
application data from the phone. This data can be visualized in real time and anomalies and flags
actioned.
Unlike today’s fragmented landscape of eCOA, imaging, sensor, and analytics
vendors, EMA Wellness operates from a unified platform architecture — accelerating configuration,
collection, and insight generation while making clinical trial data available for real-time
oversight, AI review, and sponsor-side analysis.
Data flow architecture
Configuration and Standardized data collection, structure, visualization, extracts and transfers
The EMAW platform is configurable according to each study in 4-6 weeks. The platform
standardizes data for use and application across modalities. The canonical database organizes
data across raw, derivative and transformational definitions. The benefits include real-time
data access for sponsors, but also the use of advances statistical programs, LLMs and agentic AI
tools.
EMAW is the preferred enterprise partner for sponsors requiring standardized
data across their programs for ‘big data’ analysis, and sponsors are able to access this raw
data as soon as it is received for their proprietary analysis.
01Stakeholders + Data Capture
02Multimodal Ingestion
03Standardization Layer
04Central Database + AI Signal Detection
05Reporting + Data Access
06Sponsor / FDA Visibility
1. Data capture
Device agnostic and fully web-based
- Sites, raters and subjects can use their own devices
- Data collected via browser, mobile app, API, or SDK pathways
- eCOA, EMA, audio, video, sensor/wearable, phone-based health application data
2. Multimodal ingestion
Structured ingestion of trial data before database integration.
- Normalization across modalities
- Configured per each protocol in 4-6 weeks
3. Standardization layer
Trial inputs converted into one usable clinical data foundation.
- Common schema with rows, columns, timestamps, versions, and field logic
- Data landing standardization
- Cross-modal linking across patient, rater, site, endpoint, and modality
4. Central database
Structured data lake according to raw, derivative and transformation data types
- LLM-independent scoring and agentic AI-supported quality assurance
- Real-time data visualization
- Canonical schema for views within and across sponsor studies
5. Data access
Sponsors can access data in the platform or in their own environments.
- Real-time raw data transfers to sponsors via API
- Conversion to common file formats such as CSV, Excel, or sponsor-defined structures
- Structured batch retrieval according to agreed upon data transfer specifications
- Rights-based SSO study team access
6. Sponsor audits / FDA readiness
Data generates complete audit trails.
- 21 CFR part 11, HIPAA and GDPR compliant
- Full audit trails
- Agile environment for same-day or same-week change requests
Modalities
Data modalities
eCOA
Electronic clinical outcome assessments, including clinician-rated, patient-reported, and observer-reporting outcomes.
EMAs
Ecological momentary assessments collected in the moment to provide precision insights.
Audio & video
Standardized collection according to geographical requirements and across devices.
Sensor Data
Device-generated actigraphy and biomarker data captured from consumer and 510k approved devices via API or SDK (allows access to raw, uncurated data).
Actigraphy
Activity and movement data captured over time as part of passive or device-based study workflows.
Digital biomarkers
Biomarker-derived digital measures structured for interpretation, modeling, and validation.
Passive Health Application Data
Passively collected phone-based health data such as steps, location, sleep-related measures, and other study-defined signals.
EMR / EHR
Clinical record data brought into the broader analysis-ready trial foundation.
Rater Surveillance
Monitoring and reviewing the performance of clinical raters or investigators to ensure they score patient tests accurately and consistently, preventing rater drift.
Data Standardization & Flow
Platform design, testing, configuration and production
EMA Wellness is not only collecting trial data. The platform supports the operational data work needed to configure studies, test outputs, manage ingestions, transfer data, and report cleanly to sponsors.
Configuration
Study-specific setup for scales, visits, modalities, data structures, and reporting requirements.
Testing
Access testing by third parties, EMA, and study teams prior to production.
Production
The platform is able to ‘go live’ in 4-6 weeks.
Change requests
Change requests can be completed in 1-5 days.
Data standardization
Standardized data across every trial modality
EMA Wellness integrates eCOA, EMAs, audio/video capture, sensor data, actigraphy, digital biomarkers, and passively collected Health App data into a standardized clinical data foundation. The platform ingests diverse data types and harmonizes them into a common structure, reducing fragmentation and downstream cleaning while preparing inputs for analysis.
EMA Wellness supports consistent data pipelines, real-time quality assurance, sponsor API access, and operational workflows from site activation through database lock.
Because trial modalities move through standardized infrastructure, teams can review quality during study conduct, detect outliers and anomalies in real time, and generate insights across data modality and type.
The platform is designed to improve the parts of the study timeline it can directly affect: 2–4 weeks for configuration, better quality in the middle through real-time surveillance and anomaly detection, and 2–4 weeks for database lock.
Data standardization
Analysis-ready from ingestion
Diverse data types organized into a common structure.
Raw, transformational, and derivative data structured for use.
Real-time quality checks and data integrity.
Data ready for analysis, insights, and reporting.
What this means
Standardized movement of trial data across workflows.
Quality signals available during study conduct.
Configured support for ingestions, transfers, testing, and reporting.
Cleaner data supports earlier signals and faster decisions.
Timeline + quality
Configuration
Faster on the front end.
Real-Time Surveillance
Real-time anomaly detection.
Database Lock
Faster on the back end.
Build the data layer your study needs.
Collect, standardize, integrate, analyze, access, and report multimodal trial data through one platform.
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