DECODE CRS is a pre-competitive system-wide effort to reduce hospital stays and intensive care use, and enable broader patient access to immunotherapy.
PENASCOLA, FL, April 20, 2026 – Ametris, a global digital health solutions provider transforming real-world patient data into validated clinical evidence, and the Digital Medicine Society (DiMe), a global nonprofit organization advancing the safe, effective, equitable, and ethical use of digital technologies, today announced the launch of the DECODE CRS coalition. Alongside major pharmaceutical organizations across oncology and immunology, the coalition aims to reduce barriers to immunotherapy access by enabling remote patient monitoring of the most common adverse event, cytokine release syndrome (CRS). DECODE CRS will advance continuous remote monitoring approaches that leverage real-time data from wearables and standardized clinical protocols to reduce variability in care, support earlier clinical escalation of adverse events when needed, and enable more scalable, real-world workflows, particularly outside major centers. By advancing a shared approach to CRS measurement and management, DECODE CRS seeks to support safer outpatient immunotherapy, reduce burden on healthcare systems, and improve patient outcomes, while supporting sustainable adoption at scale.
The DECODE CRS coalition brings together pharmaceutical sponsors, clinicians, regulators, payers, patients, technology developers, and healthcare systems to address this industry-wide challenge. Building on DiMe’s foundational work in digital measures for CRS, the coalition combines Ametris’ expertise in continuous sensor-based data analytics with DiMe’s cross-sector leadership and the global immunotherapy development experience of leading biopharmaceutical partners. Through its pre-competitive model, DECODE CRS aims to reduce risk, avoid duplication, and build a shared infrastructure to support improved CRS detecting and management.
“The DECODE CRS coalition is a system-level effort to build shared evidence that no single organization could generate alone,” said Samantha McClenahan, PhD, Associate Program Director, at DiMe. “The challenges of identifying and monitoring CRS are not unique to one therapy or one sponsor, they are broader constraints across bispecific antibodies and CAR-T cell therapies. Addressing them requires coordinated, cross-sector collaboration that can generate clinically meaningful evidence, support regulatory decision-making, and be applied across multiple types of immunotherapy modalities.”
The coalition will be organized around two workstreams. The first, launching April 20, 2026, will define the clinical, commercial, and regulatory requirements for CRS monitoring solutions. The second will support a prospective study of at least 150 patients receiving approved CAR-T and TCE immunotherapies to build a robust dataset for early CRS detection.
“Through a unique, pre-competitive approach, DECODE CRS aims to make CRS monitoring more scalable and efficient across care settings to accelerate innovation and expand access to immunotherapies,” said Christine Guo, Chief Scientific Officer at Ametris. “With two previous DECODE initiatives currently underway, we are excited to apply this proven collaborative framework to another shared industry challenge.”
The DECODE CRS coalition is welcoming additional members to help shape the future of CRS measurement and management. For more information, visit the DECODE CRS Project Page.
