Platform-Implementation

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