Platform Implementation
Full Service Souutions by Industry Experts
Tailored Solutions
Meeting the Needs of Today's Studies
The EMAW platform is a ‘white box’ system which provides a complete audit trail for sponsor, regulatory and other quality assurance purposes. This includes all platform engineering, configuration, rules, flags, alerts, AI models and reports. The platform is GDPR and 21cfr compliant and has been validated in global phase 2 and 3 trials.
The EMAW platform can be in production in under two weeks once rights have been obtained and the protocol has been finalized.
The platform is rights based and can be administered by sponsors, CROs or sites.
Because our platform was designed specifically to include these features, we are able to activate sites, raters and studies much more quickly, at lower cost and with much higher data integrity than other platforms constructed by piecemeal or for adjacent purposes.
Selection data sources and measures
Define and engineer rules, alerts for signal detection and reporting
Integrate adjudication processes and APIs
Sandbox environment and SOP based testing prior to going live
2 weeks once all rights are gathered
Library of more than 200 APIs to integrate device and sensor data collection
Data moved directly into a safe and structured environment
Data checks and validation
Dashboard for Adherence/compliance information and alerts
Signal visualization
Structure by site, rater, subject and study
Flags and alerts generate an automatic review of data by a qualified and training clinician
Clinicians and sponsors are notified and access files and data via their own device through the EMAW portal
Escalation path followed for remediation, further tracking and/or issue resolution
Each step is shown on the dashboard in real time (instant insight); All rights based access
Data for each study is stored in a structured, time stamped environment with full redundancy and disaster recovery capabilities
Data extracts can be scheduled as regularly as requested
Bilateral data extracts in various formats
SAPs and final reports are regulatory ready and provide full audit trail
The EMA Wellness platform has been validated by top 20 sponsors and bio pharma partners, used in 20+countries, 15+ languages, across all phases of clinical trials
- Rapid Setup: Get your trial up and running in as little as two weeks.
- Independent Video Review: Detect adverse events (AEs) with advanced video review capabilities.
- Integrated Adjudication: Seamlessly integrate adjudication functionality for streamlined trial management.
- Simplicity: Our EMAW platform is designed for easy adoption, minimizing complexity and maximizing results.
- Enhanced Subject Quality: Improve subject quality without negatively impacting enrollment rates.
- Cost-Effective Solutions: Achieve full-feature capabilities even under constrained budgets.
- Flexible Licensing: License and administer the platform independently from additional services.
- Smart Alerts & Flags: Drive enrollment quality and enhance endpoint accuracy with real-time notifications.
- Multiple Observer Inputs: Allow for multiple observers to provide input for each patient, ensuring comprehensive data collection.
- AE-Triggered Assessments: Automatically initiate assessments based on detected adverse events.
- Rich Data Collection: Collect critical audio files to capture a broader spectrum of patient data.