Addwin Consulting
Addwin Consulting Corporation is a health policy, regulatory and health-IT consulting firm with over 20 years of experience. The company provides regulatory and quality affairs support for medical devices, clinical strategy and trial support, international regulatory submissions, business development aligned to regulatory goals, and health IT solutions including EHR integration, clinical decision support, clinical analytics, and interoperability services. The firm has federal and commercial experience and identifies as an Economically Disadvantaged Women-Owned Small Business (EDWOSB).
Industries
Nr. of Employees
small (1-50)
Addwin Consulting
Herndon, Virginia, United States, North America
Products
FHIR-native EHR components and collaborative clinical documentation
FHIR-native web components for building and manipulating FHIR resources to enable live collaborative clinical documentation at point of care.
Real-time clinical decision support engine
Authoring and execution environment for semantically aware rules, guideline encoding, workflows, and models to provide real-time decision support.
NLP-based clinical knowledge extraction engine
Customizable engine to extract discrete data elements from structured and unstructured clinical documents in real time.
Real-time financial and operational costing (TDABC) system
Real-time computation of budgetary revenue and operational cost with time-driven activity-based costing to map costs to clinical process steps.
FHIR-native EHR components and collaborative clinical documentation
FHIR-native web components for building and manipulating FHIR resources to enable live collaborative clinical documentation at point of care.
Real-time clinical decision support engine
Authoring and execution environment for semantically aware rules, guideline encoding, workflows, and models to provide real-time decision support.
NLP-based clinical knowledge extraction engine
Customizable engine to extract discrete data elements from structured and unstructured clinical documents in real time.
Real-time financial and operational costing (TDABC) system
Real-time computation of budgetary revenue and operational cost with time-driven activity-based costing to map costs to clinical process steps.
Services
Regulatory strategy, device classification, testing plan development, submission preparation (510(k), IDE, PMA, EUA, 513(g)), and post-market surveillance.
Implementation and assessment of quality systems, CAPA programs, complaint management, supplier auditing, ISO 13485 implementation, and MDSAP readiness.
Clinical protocol review, statistical plan development, CRO and vendor selection, DSMB/CEC support, clinical trial safety reporting, and investigational product management.
Regulatory strategy and submission support for Health Canada, EU MDR/CE marking, PMDA (Japan), and harmonized FDA–Japan activities.
EHR and clinical system deployment, interoperability and integration, semantic modeling, system optimization, and program management for federal and commercial clients.
Development and deployment of real-time analytics, cohort and episode analysis, clinical decision support engines, and NLP-based knowledge extraction.
Regulatory strategy, device classification, testing plan development, submission preparation (510(k), IDE, PMA, EUA, 513(g)), and post-market surveillance.
Implementation and assessment of quality systems, CAPA programs, complaint management, supplier auditing, ISO 13485 implementation, and MDSAP readiness.
Clinical protocol review, statistical plan development, CRO and vendor selection, DSMB/CEC support, clinical trial safety reporting, and investigational product management.
Regulatory strategy and submission support for Health Canada, EU MDR/CE marking, PMDA (Japan), and harmonized FDA–Japan activities.
EHR and clinical system deployment, interoperability and integration, semantic modeling, system optimization, and program management for federal and commercial clients.
Development and deployment of real-time analytics, cohort and episode analysis, clinical decision support engines, and NLP-based knowledge extraction.
Expertise Areas
- Regulatory compliance and submissions
- Quality management systems (21 CFR 820, ISO 13485)
- Clinical trial design and management
- Health IT implementation and EHR integration
Key Technologies
- FHIR-based EHR components
- Clinical decision support systems (rule engines)
- Natural language processing (NLP) for clinical text
- Machine learning and predictive modeling