Paradigm Health is uniquely positioned to help sponsors participate in the FDA's RTCT pilot, covering everything from study selection and proposal development through implementation into medical centers and live signal transmissions to the FDA, powered by Paradigm Health's AI-native infrastructure.
The FDA's RTCT program enables sponsors to transmit pre-defined reporting signals to the Agency on a near-real-time basis during an active study, allowing regulators to review emerging signals as the trial unfolds rather than at submission.
The Clinical Trial Reporting Schema (CTRS) defines which safety, efficacy, data quality, and operational signals are captured, transmitted, and reviewed, including the cadence at which each occurs.
Participation requires a credible proposal, a technology partner who understands the data infrastructure, and an operating model that works for sites without creating undue burden.
Through our role in shaping the Real-Time Clinical Trials initiative and our ongoing Research Collaboration with the FDA, Paradigm Health is uniquely equipped to guide trial sponsors from interest to participation.
Paradigm Health is the technology and execution layer that makes sponsor participation in the RTCT pilot operationally viable, from proposal through the life of the pilot.
Two primary packages layered on top of core Study Conduct infrastructure, scoped to the full lifecycle of an FDA RTCT pilot.
Study portfolio assessment, CTRS strategy, site readiness evaluation, and submission-ready FDA pilot proposal with defined success metrics.
Upfront engagementFull technical data pathway from site capture through CTRS signal generation & validation, sponsor review workflow, and FDA-facing transmission, operated for the full pilot duration.
Ongoing supportDirect data capture via EHR-embedded forms, structured EHR extraction across labs, vitals, medications, and encounters, plus unstructured source material extraction.
AI-EnabledSource data verification, data cleaning, discrepancy detection, and protocol compliance monitoring calibrated for near-continuous signal transmission.
Site LevelFrom initial portfolio review through first live signal transmission and Sponsor Interface delivery for signal and corresponding source data review.
Pilot timeline
Portfolio intake and assessment against RTCT criteria, site network overlap analysis, and go/no-go recommendation.
Define candidate CTRS signals across safety, efficacy, and operational domains. Map to available data sources and surface gaps.
Submission-ready narrative covering study rationale, CTRS framework, Paradigm Health's technology role, proposed site model, and defined success metrics.
Configure the technical transmission pathway, validate source data mapping, establish FDA-facing API connectivity, and confirm go-live readiness.
Translate finalized CTRS into executable signal logic, configure generation against the normalized data layer, and support first live transmission.
Role-based sponsor visibility, signal routing and escalation, FDA-facing access, audit trails, and correction workflow configuration.
Full pilot operations including signal monitoring, CTRS change control, and Sponsor Interface delivery for signal and corresponding source data review.
We will walk through the FDA pilot model, how your study portfolio fits, and what Paradigm Health's involvement looks like from day one.
