Rancho Cordova, California (PRWEB) June 28, 2013
CareLex, a non-profit public advantage organization for BioInformatics analysis and development, these days announced that it has submitted the CareLex eTMF Reference Model for health sciences content classification to regulatory agencies worldwide, including the FDA in the USA, the European Medicines Agency, the Ministry of Wellness, Labour and Welfare in Japan and the State Meals and Drug Administration in China.

Created for use in clinical trials for pharmaceutical and medical device research organizations, the CareLex content classification model addresses BioPharma sector electronic content classification and content interoperability concerns. The CareLex model makes use of a standards-primarily based content material classification model that permits sharing and exchange of clinical trial digital content material among organizations globally.

As clinical trial stakeholder organizations seek to move from paper-primarily based research to electronic, network driven approaches, information interoperability, information standards and agency compliance are important variables in accelerating the secure delivery of therapies to individuals globally, said Zack Schmidt, Executive Director of CareLex. With the CareLex Model normal, clinical trial investigation organizations can electronically share clinical trial content material among globally distributed analysis teams.” The CareLex model specification is offered for totally free download at http://www.CareLex.org

The CareLex Reference Model provides an interoperable foundation that all stakeholders in the clinical trial worth chain can develop upon. By adopting the CareLex Model, clinical trial stakeholder organizations can seamlessly share clinical trial information utilizing a requirements-based model to collaboratively raise the effectiveness and efficiency of clinical trials. CareLex is a versatile model that can be adapted to meet organization certain organization models, whilst at the identical time offering content exchange interoperability. The CareLex Model is proposed as a guideline for use by stakeholders all through the clinical trial process who create, handle or exchange clinical trial regulated content.

CareLex Reference Model Functions
The CareLex Reference Model for the Electronic Trial Master File (eTMF) domain offers clinical trials stakeholders with the following foundation to create clinical trial details interoperability:

A standards-primarily based foundational architecture consisting of 3 layers that are obtainable in a machine readable database:

-1st – Use of requirements-primarily based published vocabularies or terms developed and curated by top overall health science organizations, such as the National Cancer Institute, HL7, CDISC, FDA and other industry resources.

-Second – A published, machine-readable content classification layer that is operating method and application independent.

-Third Adoption of world wide web standards for information classification and exchange.

In addition to the CareLex requirements-based foundation, the CareLex Model consists of assistance for the following:

-Workflow and organization procedure support the CareLex Model involves help for use of the Business Method Modeling Notation (BPMN) standard

-Audit trail assistance Help for record timestamping and audit trail detail capture

-Digital Signature assistance

-CareLex technologies are freely licensed to any organization under the terms of the Apache two. open supply license.

The CareLex Reference Model can be employed with any electronic record maintaining method: From straightforward file technique and folder approaches all the way to sophisticated electronic content material management systems.

The CareLex Reference Model provides clinical trial stakeholder organizations with an interoperable strategy to accelerate data exchange for worldwide clinical trials, lowering paper, enhancing compliance efforts, and enhancing clinical trial technologies collaboration.

The CareLex Model is published on-line at the US National Center for Biomedical Ontologys (NCBO) BioPortal website. The CareLex model can be viewed, commented on and downloaded at: http://purl.bioontology.org/ontology/CareLex

About CareLex
CareLex is a non-profit public benefit organization for BioInformatics study and improvement. Organized in 2012 by a core group of clinical trial domain and bioinformatics specialists, CareLex gives open supply technology for BioPharma content material classification and management. CareLex is open to any individual worldwide. For more information, visit http://www.CareLex.org.

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Trademarks
CareLex is a trademark of CareLex

Copyright 2013 CareLex, a non-profit public advantage organization for BioInformatics investigation and improvement.

Media Contacts
Zack Schmidt
CareLex 
admin(at)CareLex(dot)org





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