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CDISCClinical Data Interchange Standards Consortium
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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.
CDISC is comprised of nearly 200 global organizations including leading Biotech and Pharmaceutical companies, CROs, and academic institutions.
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.
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.
True bi-directional interface support of HL7, CDISC LAB, and other standards
I have been a champion of CDISC for many years and look forward to my continued support of the organization and its vision to 'inform patient care and safety through higher quality medical research.
And the refusal cited above is arguably the highest profile example of the agency stressing the importance of standardized datasets and the implementation of CDISC data standards.
The release of these two standards marks the first time that TA standards have been fully developed through the CFAST partnership using the enhanced CDISC standards development process.
The focus of CDISC SHARE is on integrating the CDISC standards family into an aligned, linked, machine-readable and openly accessible metadata repository.
Our commitment to standards and our customers is exemplified through our continued effort to expand our CDISC capabilities.