clinivation RealWorld^®

Real-World in Real Time.

Clinivation RealWorld leverages the world’s leading platform for EHR interoperability and connected care to deliver fresh, high‐quality data, personalized analytics, and massive economies of scale.

Unlike conventional real‐world evaluations, Real‐ World in Real Time enables industry, third‐party, and public stakeholders to realize the transformative potential of real‐world evaluations.

Conventional Real-World Evaluations are Limited by Stale, Low-Quality Data and High Cost.

Unlike Real‐World in Real Time implementations, conventional real‐world evaluations are limited by low data quality.

Conventional billing and claims data is stale‐ months or years old‐ by the time it’s analyzed and reported. Source data is incomplete from exclusion of the unstructured, textual and m‐Health records, and from data gaps intrinsic to site‐specific reporting that excludes off‐site follow‐up. And closing data gaps can be impossible, because coding and claims adjudication lumps together or ignores many or the actual clinical activities, observations, diagnoses, and events.

This low data quality is well‐documented with contemporary health policy research that has demonstrated, for example, claims‐to‐discharge concordances as low as 70% for certain procedures reported through both the U.S. Medicare claims and the U.S. National Discharge Summary databases.

These national‐level reports of low data quality are consistent with claims‐to‐clinical discordances demonstrated in diabetes, for example, where kappa values of claims‐to‐clinical agreement are generally only around 0.7, and fall to as low as 0.4 for elderly populations. And low data quality has also be documented in surgical specialties, for example, where claims‐to‐clinical kappa values may generally only be around 0.6‐ and even fall to below 0.25 for instances of prosthetic failure, breakage, and mechanical complications. And because ICD‐9 lacks laterality information (i.e., same‐side vs. contralateral side), claims‐toclinical concordances of below 25% for revision total knee and total hip arthroplasty, for example, have also been demonstrated.

Compounding the problems of low data quality is the prohibitive cost of conventional real‐world evaluations, which often exceeds US$10,000 per evaluable subject.

Real-World in Real Time Leverages EHR Interoperability for High-Quality Data and Scalability.

Real‐World in Real Time implementations leverage the world’s leading platform for EHR interoperability and connected care to deliver fresh, high‐quality data, personalized analytics, and massive economies of scale.

Combining breakthrough interoperability technology, world‐class security, access to textual and m‐Health records, and personalized analytics, Real‐World in Real Time implementations enable industry, third‐party, and public stakeholders to realize the transformative potential of real‐world evaluations.

Visualize and explore your critical metrics of utilization, outcomes, and reimbursement with clinivation RealWorld® Interactive Analytics, and gain insights from real time streams of realworld data.

• Connect Knowledge With Cross‐Functional Teams including clinical development, health economics and outcomes research, medical affairs, safety, commercial, marketing, product development, risk management, and more.
• Deliver Insights with Personalized, Relevant Analytics for Specific Functional Requirements addressing premarket, postmarket, third‐party, public, and other initiatives.
• Built for Rapid Integration with medical device, clinical development, electronic health record, and enterprise infrastructure, including EMR/EHR, EDC, CDMS, CTMS, CRM, CMS, and ERP systems.
• Exportable Analytics Simplify Issue Analysis and Presentation and leverage search, user‐defined queries, libraries, and templates, for pivot‐table functionality and exportability to all desktop applications.
• Runs in clinivation Cloud^® to Bring People and Knowledge to the Point of Action and seamlessly interoperate with modular EHR‐Integrated Patient Registry, Clinical Portfolio Strategy, Global Product Value Management, and other clinivation applications.
• World‐Class Performance that’s Built on the InterSystems HealthShare Health Informatics Platform, with advanced technology for strategic interoperability and analytics for action within a single facility, or across a hospital network, or the healthcare system of an entire nation. InterSystems‐ the world’s leading platform for connected healthcare.
• Supports Standards and Profiles Required for Interoperability and document‐based health information exchange with other healthcare organizations, clinicians, and public health agencies. Supported standards include: IHE profiles, CDA and CCD, NwHIN Direct, HL7v2, HL7v3, DICOM, X12, ITK (United Kingdom), NEHTA (Australia), and DMP (France), and applicable terminology standards (i.e., LOINC, SNOMED, and ICD) or custom code sets, as appropriate, to ensure semantic interoperability between systems.
• Robust Data Quality, Security, and Administration with audit trail reporting, electronic signatures, multi‐level administrative and security options, and secure architecture that has been validated to meet or exceed US, EU, Japan, Canada, and other standards for clinical development of regulated medical products.
• The clinivation clinStart^SM Family of Solution Services Immediately Addresses Your Top Priorities and accelerates a priority‐driven implementation of the clinivation CareSite Platform with a proven approach to this specialized area.
• Clinivation Solution Services Deliver Full Support and include planning, architecture, configuration, development, data migration, validation, documentation, training, launch, support, and program management.