White Paper

White Paper:

FDA Study Data Exchange Standards - The Case for CDISC Adoption

In November 2012, the Food and Drug Administration (FDA) held a public meeting, “Regulatory New Drug Review: Solutions for Study Data Exchange Standards”. The meeting solicited input from industry, technology vendors, and other stakeholders regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. 

The Formedix team - experts in CDISC standards since their inception in 2000 - responded in support of CDISC as the chosen Study Data Exchange Standard.

Download our Technical Expert Opinion Piece to discover more.

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