How a phased CRO partnership built on ICH E6(R2) and E6(R3) principles supported a multi-indication biotech portfolio.
|Articles|November 30, 2016
CDISC FDA Binding Guidance In Effect Soon
The Clinical Data Interchange Standards Consortium (CDISC) is reminding the clinical research community that the FDA Binding Guidance goes into effect in December.
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The Clinical Data Interchange Standards Consortium (CDISC) is reminding the clinical research community that the FDA Binding Guidance goes into effect in December. Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog.
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