Paradigm Health is uniquely positioned to help sponsors participate in the FDA's RTCT pilot — from study selection and proposal development through live CTRS data transmission to the Agency.
The FDA's RTCT program enables sponsors to transmit structured trial data to the Agency on a near-real-time basis during an active study — allowing regulators to review emerging signals as the trial unfolds, not at submission.
The Clinical Trial Reporting Schema (CTRS) defines which safety, efficacy, data quality, and operational signals are captured, transmitted, and reviewed — and on what cadence.
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.
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, sponsor review workflow, and FDA-facing transmission — operated for the pilot duration.
Ongoing supportDirect data capture via EHR-embedded forms, structured EHR extraction across labs, vitals, medications, and encounters, plus unstructured source material extraction.
Per site, per monthSource data verification, data cleaning, discrepancy detection, and protocol compliance monitoring — calibrated for near-continuous signal transmission.
Per site, per monthFrom initial portfolio review through first live signal transmission and ongoing pilot support.
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, cross-functional issue resolution, and periodic operating reviews.
A walkthrough of our data capture model, CTRS signal workflow, and FDA transmission architecture.
We will walk through the FDA pilot model, how your study portfolio fits, and what Paradigm Health's involvement looks like from day one.