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CDISCClinical Data Interchange Standards Consortium
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CDISC Standards were originally developed to enhance the review of safety and efficacy data, and most recently have been extended in specific disease areas.
Beyond migrating or mapping proprietary data to CDISC standards, respondents said that a number of challenges pose significant demands on their already stretched resources, including: Development and support for new standards, processes and infrastructure; developing standards governance structures across functional areas; training people to implement the standards; and putting management processes in place to verify compliance with the new standards.
Leading to faster and 'smarter' research, the CDISC global TA standards can streamline how clinical research is conducted to allow data to be readily shared among clinicians, researchers and regulators across the world.
Kanevsky created an open source, freely available toolkit that enabled the implementation of CDISC standards, which revolutionized the way the life-sciences industry exchanges clinical data.
According to the purpose of how clinical trial data is used, CDISC provides various standard models.
The scope of CDISC was initially focused on defining new data standards to support the electronic acquisition, exchange, submission, and archiving of clinical trials data, primarily in commercially-sponsored studies.
The CDISC Lab Team, composed of representatives from central clinical laboratories, pharmaceutical companies, CROs, and technology-application developers, has developed a model to support the acquisition and interchange of clinical laboratory data from a performing, reference, or central laboratory into an operational database at a central laboratory, sponsor pharmaceutical or biotechnology company, or CRO.
I am pleased to represent ACRO on the CDISC Board of Directors and offer the voice of the global CRO industry," said Peddicord.
This CDISC Therapeutic Area standard was funded with support in part by grant U24FD005243-01 from the US Food and Drug Administration and developed through the Coalition for Accelerating Standards and Therapies (CFAST) initiative, a partnership of CDISC and the Critical Path Institute (C-Path), with participation from the US NIH National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), FDA, TransCelerate, the Japan Pharmaceutical and Medical Devices Agency and additional stakeholders.
True bi-directional interface support of HL7, CDISC LAB, and other standards
As a CDISC Gold member, Algorithme Pharma can further collaborate with global leaders and contribute toward the development and release of new standards.
CEO of Formedix, Mark Wheeldon, said : 'By collaborating with OmniComm, not only can our customers take advantage of Formedix's ability to reduce study specification times by over 60% but, with this new level of integration, all customers can benefit from automation from vendor neutral CDISC standards on an even greater scale.