Clinical Documentation, Clinical Research, Disease Management

 

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eSphere is a complete clinical trial and data management system serving the needs of physician investigators, monitors, clinician caregivers, safety and regulatory monitors, data and project managers.  It is designed and built with protocols at its core rapidly accelerating the clinical research process.   eSphere assures the security and integrity of the research data while providing the researcher with real time access on demand.

 

Web based forms collect and verify data

Protocol Authoring, Tracking and Monitoring

 

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Assures that requirements for proper preparation of the clinical research protocol are met

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Follows process for protocol submission and IRB approval process

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Library of standard forms can be easily adapted, reused and shared across multiple protocols

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Maintains version control of the protocol and all amendments and automatically tracks history of all changes

 

Accelerated Research Study Design 

 

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Simple drag and drop environment allows you to define database, metadata criteria, design form and test in real time. 

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Ability to model complex patient and data flow processes, matching the actual protocol precisely.

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Incorporate instructions, reminders, and warnings into the data entry screens.

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Library of standard forms can be easily adapted, reused and shared across multiple protocols.

 

Real Time Data Capture and Quality Data 

 

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On-line patient registration and assignment to protocol facilitates easy identification of cohorts and eligibility determination.

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Coordinated collection of data assured elimination of wrong forms, errors of omission and prevalence of N/A’s.

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Same patient, same encounter coordination increases patient safety.

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Interfaces acquire data from other clinical databases eliminating redundant data entry errors.

 

Centralized Data Repository 

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Data Dictionary built upon unique, highly flexible data structure or “model” that enables users to exchange, compare, query and report on data from one protocol, across protocols, even from data originating in independent systems.

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Enables a single longitudinal patient record to integrate all data across current and prior studies

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Coordinated central knowledgebase of protocols

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Allows researcher’s to access data and export to specialized database – with 100% protection of their ownership of data

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Capability to manipulate and analyze data via without impacting the original source

 

Effective Trial Control and Monitoring 

 

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On-line forms enable instant source document verification

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Compliance with protocol flow and timing of events assured.

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Ability to conduct independent data quality checks from remote locations

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Automated triggers improve response to unplanned and adverse events

 

Analyses and Reporting

 

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Powerful, yet easy to use wizards provide tools for ad-hoc queries and analyses

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Data can be easily extracted and exported to Excel, SPSS, or SAS or other tools for sophisticated statistical analysis

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Web based portals are user defined, protocol specific, or defined by clinician location

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Standard reports are grouped into research reports and analyses, regulatory reports, clinical reports and      administrative counts

Hierarchical Display of Research Study

 

A PDF version of this eSphere brochure
is available for viewing by clicking on the following link: 


pdf  eSphere for Clinical Trial Brochure


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Clinical Documentation, Clinical Research, Disease Management

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