EMA Wellness and Mira Analytics Enter into Exclusive Partnership to use Proprietary AI to Validate Endpoints in Clinical Trials

EMA Wellness and Mira will team to leverage EMAW's market leading data capture platform to run the most advanced LLMs validated in today's global CNS registration trials

BOSTON and PRAGUE, May 14, 2026 /PRNewswire/ -- EMA Wellness (EMAW), a leading clinical trial data platform for AI-enabled eCOA, central ratings and analytics, today announced an exclusive partnership with Mira Analytics to deploy AI-driven endpoint validation and rater surveillance across global CNS clinical trials. EMAW's platform standardizes the collection of multimodal data - including eCOA, audio/video, EMA, digital biomarkers, and passive sensor data - within a unified architecture. The EMAW single stack platform enables real-time analytics and AI-driven signal detection to enable Real Time Clinical Trials, inform precision study design and drive enhanced subject selection/stratification, and endpoint reliability. EMAW's single code platform has been validated across multiple Phase 2 and 3 global trials, and is HIPAA, GDPR and 21 CFR part 11 compliant.

Mira Analytics' AI models are grounded in its founding team's experience working to assess and independently score thousands of recorded clinical interviews in Phase 2 and Phase 3 global CNS trials. This experience and access to data, unparalleled in the market and combined with one of Europe's most sophisticated engineering teams, separates Mira's ability to deliver AI enabled rater surveillance with improved accuracy, speed and cost. Mira's AI models generate independent scores and quality assessments which automate flags where there is discordance from primary ratings, thereby helping sponsors improve rater consistency and reliability in real time, and make better inclusion, stratification and remediation decisions during the course of a trial.

"Our focus is on ingesting high-quality, multi modal clinical data and making it actionable in real time," said Colin Bower, co-founder and CEO of EMA Wellness. "By integrating Mira's models directly into our platform, sponsors can move from retrospective review to continuous quality assurance across their trials. This effort, combined with the API access we provide our sponsor partners for real time data access, also enables our partners to use AI to signal detect across data modalities at a study and enterprise level – something sponsors and the FDA are seeking today."

"We're delighted to partner with EMAW, whom we view as the leading data capture platform active in clinical research today," said Mira co-founder and CTO Miguel Pinheiro. "Their platform will allow us access to the required audio standards as well as enable us to work with more sponsors to accelerate the use of our models in trials." 

"We've worked with Mira founders for several years, and our workstreams analyzing, assessing and adjudicating recorded interviews have had a real impact on endpoint quality while generating substantial ROI for our sponsor partners", said Bower, "and our integrated AI solution has the added benefit of being turn key – no need for additional test scripts, data transfer specifications or validation of quality management systems."

"Clinical interviews remain the most information-rich data we collect in CNS trials, and also the hardest to measure consistently," said Mira co-founder and CEO, Adam Kolar. "That's the gap our models are built to close. Working alongside EMAW means we can apply that precision at scale, across more programs and more therapeutic areas."

About EMA Wellness

EMAW has achieved a strong ROI for sponsor partners, including the ability to capture and quality assure 100% of all clinical interviews and remediate poor quality sites and raters. AI-driven flagging enables targeted, real-time review by clinicians, significantly reducing manual effort and cost while improving ratings quality and consistency. 

EMAW's web-based technology and singular code base drive the feature functionality of its proprietary GIANT™ platform. GIANT™ standardizes multimodal data collection in clinical trials, including eCOA, EMA/diary, sensor, passive and other real-world data sources, via its proprietary application, browser-based interface, SDK, or API. Standardization of these data enables real time AI enabled analysis and signal detection for enhanced subject selection, endpoint reliability and phenotyping for treatment effect. EMAW uses AI tools vigilantly to enhance data ingestion, platform configuration, testing and analyses. Sponsor partners can access the data in real time via rights-based access to the platform or in their own environment via API to actively leveraging EMAW's unique data sharing capability by integrating EMAW's platform with their own systems for proprietary AI driven insights. 

EMAW's multi modal platform is being used to more effectively assess data, signal detect, and phenotype patients for faster readouts as well as to predict treatment effect and define inclusion/exclusion criteria in smaller, higher powered follow-on trials. The platform provides full audit trails across data and the patient journey, enhancing how sponsors report to the FDA. 

EMAW is leading the charge toward precision insights, treatment and medicine, and will continue to work to be a leading factor in substantially reducing drug approvals timelines, cost and risk. EMAW was founded in 2018 by clinical research leaders, technology experts, and industry executives to improve outcomes in CNS clinical trials through contemporary, validated technology. The EMAW platform is being used in more than 25 countries and by over 250 sites.

About Mira Analytics

Mira Analytics builds AI models that bring precision and consistency to clinical measurement in CNS trials. Its models analyze recorded clinical interviews — across text, audio and video — to generate independent, reproducible scores used for rater surveillance, quality assurance and endpoint validation. By flagging discordance from primary ratings in real time, Mira helps sponsors improve the reliability of primary endpoint data, reduce variance, and accelerate decision-making in study.

Mira's approach builds on findings presented by its founders at a leading CNS clinical trials methodology conference [1], showing that AI models can independently score clinician-rated interviews at a level comparable to expert human raters. Building on this foundation, Mira develops models for rater surveillance and endpoint validation, with ongoing validation across different measures and conditions. Models can be trained on retrospective data or on rater training materials, and standardized at trial outset or generative in study.

Beyond individual scoring, Mira's platform surfaces trends across raters, sites and studies — giving sponsors an analytical view of measurement quality that has historically been difficult to access. These insights help identify systematic rating patterns early, support targeted training, and improve consistency across global programs.

Mira's models are grounded in its founding team's deep experience training AI across thousands of clinical interviews in Phase 2 and Phase 3 global CNS trials. Mira Analytics is headquartered in Czechia, and works with leading biopharma sponsors and CROs running global CNS programs.

Contact: Colin Bower, CEO, [email protected]

SOURCE EMA Wellness