Internal Sponsor Systems

Sponsors achieve internal research system interoperability by adopting FHIR for R&D information exchange.

This workflow outlines how clinical research sponsors leverage internal systems, structured authoring tools, and technology providers to streamline protocol development, data collection, and reporting using FHIR (Fast Healthcare Interoperability Resources) standards. The goal is to enhance efficiency, data quality, and regulatory alignment across the clinical trial lifecycle. Connecting a digitized protocol to the EDC is exciting related to the ability to accelerate the creation of the standard CRF’s to support Clinical Research.

Outcomes and Benefits:

  • Structured Protocol Design: Accelerates authoring, reduces ambiguity, and aligns with regulatory expectations.
  • Interoperability with FHIR: Enables seamless data exchange between sponsors, sites, and regulators.
  • Improved Data Quality and Reuse: Facilitates use in downstream systems, for this use case, the digitized SOA is provided to OpenClinica to automate the creation of the standard Case Report Forms in the EDC.
  • Operational Efficiency: Reduces rework, improves timelines, and supports adaptive trial capabilities.

What

Sponsors can achieve internal research system interoperability by adopting FHIR for R&D information exchange, including:

  • Digitized clinical protocols
  • Structured Schedules of Activities
  • Adverse event data sharing
  • RWD utilization

Why

Research systems used by sites and sponsors (e.g., EDCs, CTMS, IVRS, Trial Master Files, etc.) can move beyond point-to-point integrations and manual duplication of data.

Increased industry alignment with the rest of the healthcare ecosystem will benefit from ongoing investment in FHIR-based Health IT tools in pursuit of a “write once, run anywhere” ecosystem.

Benefits

  • Improved data quality and data collection efficiency
  • Streamline study planning, startup, and execution
  • Alignment of clinical care and clinical research to benefit patients and reduce site burden
  • Move from siloed systems into a cohesive infrastructure, with improved ROI and ability to leverage AI/ML

Internal Sponsor Systems Workflow

Resources & Implementation Guides

A program of work was initiated under Vulcan to deliver an Implementation Guide for this topic

Schedule of Activities Implementation Guide

For more information on this use case, please contact Cal Collins at [email protected]