clinivation ClinicalSuite^®

Clinical Apps for Connected Workflow.

Clinivation ClinicalSuite enables connected workflow with flexible, personalized applications that connect all stakeholders across the entire clinical development lifecycle.

Unlike centralized systems, personalized applications deliver relevant analytics to the point of action and empower teams, investigators, and patients to participate, learn, and work together with synchrony and simplicity.

New Development Models and New Healthcare Environments Create Disconnected Workflow.

Clinical development cannot function if it is disconnected from patient care.

In fact, connected workflow is the single most important success factor in clinical trial recruitment. And disconnected workflow has been shown to decrease the quality of patient care, to decrease physician trust and participation, to reverse any efficiencies gained by EDC, and to increase EDC data entry errors by 1,100%.

Increasingly, major secular trends are disconnecting workflow as clinical development and patient care evolve in different directions. New development models employ new development workflows, which address contemporary adaptive trial designs, risk‐based monitoring, outcomes instruments, comparative endpoints, and patient engagement requirements. By contrast, new healthcare environments are shaped by new care workflows, which are driven by contemporary meaningful use objectives, accountable care outcomes, clinical quality measures, and value‐based health care metrics.

Connect into Workflow and Work Together with Synchrony and Simplicity.

Clinivation ClinicalSuite applications are built to connect knowledge and people into workflow‐ with flexibility, personalization, and modular interoperation.

Unlike centralized systems, personalized applications deliver relevant analytics to the point of action and empower teams, investigators, and patients to participate, learn, and work together with synchrony and simplicity.

The clinivation Encounter Mining application connects care workflow with development workflow‐ empowering teams, investigators, subjects, and study volunteers with multitudes of opportunities to participate, learn, and work together across the entire clinical development lifecycle.

• Interoperating Clinical Applications Connect People and Knowledge Into the Entire Clinical Lifecycle including Recruiting (CTRSS), Electronic Data Capture (EDC), Adverse Event Reporting (AERS), Clinical Data Management (CDMS), Clinical Trial Management (CTM), and other applications for total support of web‐based, hybrid, and paper‐based studies.
• EHR Integration and Validated Device Applications Connect People and Knowledge Into Complex Workflows with mobile, tablet, laptop, desktop, server, network‐attached storage, PACS workstation, film digitizer, and electronic medical devices, as may be required.
• 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.
• Software That’s Ready for Your Teams, Your Infrastructure, and Your Business Processes and seamlessly adapts to your needs‐ leveraging cloud, hybrid, and on‐premises architectures.
• Built for Rapid Integration with medical device, clinical development, electronic health record, and enterprise infrastructure, including EMR/EHR, EDC, CDMS, CTMS, CTRSS, CRM, CMS, and ERP systems.
• 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 international standards for clinical development of regulated medical products.
• The clinivation clinStart^℠ 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.