Powering Real-Time Clinical Insight for Coya Therapeutics’ Phase 2 ALS Study

At Miracle, we’re proud to partner with Coya Therapeutics, a clinical-stage biotechnology company focused on developing multi-modality Treg therapies for neurodegenerative diseases. As Coya executes its Phase 2 clinical trial in amyotrophic lateral sclerosis (ALS), real-time visibility and seamless access to study-, site-, and patient-level data are critical to maintaining rigorous medical oversight and operational efficiency.

Miracle is supporting Coya by serving as the central control room for the study, bringing together fragmented clinical trial data into a single, real-time platform that empowers clinical operations, medical review, and leadership teams alike.

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‍The Challenge: High-Stakes Medical Review in a Complex ALS Trial

ALS trials present unique challenges. Patient populations are small, disease progression is heterogeneous, and timely, accurate interpretation of inclusion criteria and safety data is essential.

For Coya’s Phase 2 study, data was being captured across multiple systems, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), central labs, electronic Clinical Outcome Assessments (eCOA), and manually maintained Excel spreadsheet trackers, making it difficult to quickly assemble a comprehensive picture of each participant.

Key challenges included:

• Fragmented data across systems, slowing medical review and increasing operational burden
• Manual Excel-based trackers, requiring teams to log into EDC, IRT, and lab portals and routinely update and reconcile information by hand
• Manual eligibility review, creating delays during screening and increasing coordination overhead

With increased screening activity underway, Coya needed an approach that could enable faster, real-time decision-making without adding operational overhead.

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“Miracle has fundamentally changed how we interact with clinical trial data. In prior roles, obtaining patient data required setting up meetings with an operations and data management team, and it could take weeks. With Miracle, we can review patient-level safety, labs, and clinical data in real time with a single dashboard. The transparency and accessibility of the platform meaningfully improves the speed and quality of medical oversight.”

Fred Grossman, DO, FAPA
Chief Medical Officer, Coya Therapeutics

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Enter Miracle: A Unified, Real-Time Control Room

With Miracle’s out-of-the-box integrations, Coya was up and running quickly with dashboards designed specifically for clinical and medical stakeholders. As screening ramped up, Miracle provided immediate value by consolidating all relevant patient data into a single, intuitive interface.

Miracle enabled Coya to:

• Streamline Medical & Eligibility Review: Provide the medical monitor with direct, real-time access to patient profiles and targeted views for eligibility review, eliminating delays and dependency on manual data pulls.‍
• Centralize Patient Profiles: Combine study progression, demographics, labs, disease characteristics, dosing, and safety data into one cohesive view.‍
• Support Enrollment & Scenario Planning: Model enrollment projections, protocol amendment scenarios, and site-level trends.‍
• Empower Self-Service Analytics: Enable non-technical users to interact with data, build custom visualizations, and answer questions on the fly without waiting on reports from their CRO.

By replacing manual trackers and siloed systems, Miracle allowed Coya’s team to focus on interpretation, strategy, and proactive intervention.

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“For the first time, we have a truly comprehensive, real-time dashboard that brings together data from across multiple systems into a single, intuitive view. Instead of manually tracking information in Excel, our team can immediately access the insights needed for decision-making, and we’re even a step ahead of our CRO with respect to enrollment! What used to take days, if not weeks, now takes minutes, and the responsiveness of the Miracle team has been exceptional.”

Karen King, MS
SVP, Program Management & Clinical Operations, Coya Therapeutics

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‍Early Impact

As patients entered screening, Miracle quickly became embedded in Coya’s daily workflow, supporting real-time collaboration between clinical operations, medical leadership, and external partners.

What previously required days of coordination across teams can now be done independently, in minutes, with confidence that the data is current and complete.

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“Miracle has significantly streamlined how we work with clinical trial data. What previously required extensive manual tracking in spreadsheets is now fully automated in a single, intuitive platform. The dashboards are easy to use and allow us to quickly access the information we need, which has meaningfully improved efficiency across the team.”

Tyrell Simkins, DO, PhD
Senior Director, Clinical Development, Coya Therapeutics

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‍Looking Ahead

Coya Therapeutics is advancing a critical ALS program where speed, precision, and insight matter. We’re honored to support their team with the infrastructure needed to run a modern, data-driven clinical trial, and excited to continue expanding our partnership as the study progresses.

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About Miracle

Miracle is reimagining clinical trial management by serving as the control room for clinical trials. Our platform integrates data from multiple clinical systems into a single portal, delivering real-time automated insights that reduce manual spreadsheet trackers, improve oversight, and accelerate data-driven decision-making across clinical teams.

For more information, visit miracleml.com or contact sales@miracleml.com.