CDISC Standard

CDISC Standard

A proposed uniform CDISC standard intended to address the life-cycle of a clinical trial (protocol representation, capture of source data, submission of the data to the FDA and archiving), using a set of fully integrated and consistent models, terms and controlled vocabularies derived from the current set of CDISC standards.
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Another important CDISC standard is the Study Data Tabulation Model (SDTM), a standardized representation for clinical trials observations using a set of standard data variable names and table structures.
Are data standards on your radar screen? And will they affect your manufacturing processes?
We are impressed by WIL's commitment to create more value for their clients through these enhancements and as the leading provider of SEND solutions, with more than 30 licensed sites in 11 countries, we are especially encouraged to see WIL supporting a critical FDA-adopted CDISC standard in preclinical.
WIL Research Partners with Instem for Global Harmonization Project
OTCQX: DTRK), a leader in developing cloud-based, unified eClinical technologies and delivering related services for the clinical trials industry, today announced the addition of the CDISC Standard for Exchange of Nonclinical Data (SEND) Registered Solutions Provider to existing CDISC registrations.
DATATRAK Recognized for CDISC Leadership
They invested significant in-kind resources to remap the retrospective data to the new format that is now the CDISC standard.
Critical Path Institute and Clinical Data Interchange Standards Consortium Announce Release of Data Standard for Alzheimer's Disease Research
This environment will enable FDA pharmacologists / toxicologist reviewers and statisticians to access, manipulate, and analyze nonclinical regulatory submissions in electronic formats including the CDISC Standard for the Exchange of Nonclinical Data (SEND).
PointCross Life Sciences to Provide the FDA With Nonclinical Study Data Software and Services
CDASH is the CDISC standard for case report forms (CRFs) that is harmonized with SDTM and other CDISC standards.
Critical Path Institute and Clinical Data Interchange Standards Consortium Host International Program at New Training Facility
xml metadata description file in CDISC standard format.
Phase Forward Announces WebSDM[TM] Release 3.0, with Support for CDISC Version 3.1.2 Standard
Late last year, FDA issued a mandate that studies starting after December 17, 2016, must be submitted electronically and in conformance with CDISC standards.
FDA Renews Pinnacle 21 as Software Provider for DataFit
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.
United States : MUCH-AWAITED version of TRANSFORM for TRIALMASTER launched
The adoption of CDISC standards has greatly helped this situation by creating several formats to facilitate data exchange.
The evolution of clinical integration: David Stein and Solomon Shacter, ClinPhone, discuss the bebefits of an integrated clinical trial
CDISC standards are vendor-neutral, platform-independent, and freely available via the CDISC website.
ACRO Executive Director Elected To Clinical Data Standards Group Board
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.
Pinnacle 21 CEO Max Kanevsky Named to PharmaVOICE 100

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