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Graph-Based Schedule Of Activities Specification and Management
denoto is a graph-based protocol specification methodology turning protocol Schedule of Activities (SoA) requirements into confirmed FHIR and other interoperability specifications
By leveraging the inherent simplicity of a directed graph—defined by source, edge, and target—this approach enables exceptional flexibility and precision in representing study workflows, capturing not only core visit and activity sequencing but also conditional logic, footnotes, and requirements embedded elsewhere in the protocol text. The resulting graph can be systematically exported and mapped to executable FHIR PlanDefinition resources, enabling seamless integration into electronic health record (EHR) systems at clinical research sites to support protocol-driven study execution. The graph contains all the required data to export the scheduling to CDISC’s Unified Study Definitions Model (USDM).
FHIR Defined and Fully Coded Activity Libraries
actlib is a collection of extensive Activity definitions providing reusable, semantically grounded building blocks for protocol execution.
The Activity Libraries are composed of standardized FHIR resources—including ActivityDefinition, ObservationDefinition, and SpecimenDefinition—that formally describe study activities and data collection requirements in a machine-interpretable manner. Designed for scalability and efficiency, these libraries enable consistent reuse of common study activities across protocols, reducing duplication while ensuring alignment between study design and execution. By grounding these definitions in established clinical care standards such as LOINC and SNOMED CT, the libraries ensure semantic interoperability, guaranteeing that protocol requirements are precisely and consistently mapped to the data across EHR systems.
Study EHR/EMR Emulator for Direct Data Capture Review and Testing
emu is a comprehensive study EHR/EMR emulator for scenario evaluation, data pipeline user acceptance testing, and research site activity workflow optimization.
The emulator supports a wide range of realistic, protocol-driven and protocol-deviant study scenarios, including completion strictly per protocol, early subject withdrawal, screening failures, unscheduled visits, skipped visits or activities. These scenarios enable rigorous evaluation of downstream data flows, operational readiness, and system behavior under real-world conditions. By generating representative clinical research data across key FHIR resources—such as Encounter, Appointment, Observation, Specimen, AdverseEvent, and MedicationRequest—the emulator provides a controlled yet realistic environment for validating EHR integrations, testing interoperability pipelines, and optimizing data management operations during live study execution.