PK Submit Introduction

PK Submit is a Phoenix Plugin designed to automatically generate the CDISC domains and supporting documentation relevant to non-compartmental analysis (NCA) used in electronic submissions to regulatory agencies as part of an Investigational New Drug (IND) or New Drug Application (NDA).

PK Submit supports the generation of CDISC domains in either the SDTM (Study Data Tabulation Model) or the SEND (Standard for Exchange of Nonclinical Data) format.

CDISC SDTM is a unified way of transmitting information in drug studies with precise column names and a common file format. The CDISC STDM implementation in PK Submit is compliant with the standards in the SDTM Implementation Guide: Human Clinical Trials version 3.2/3.3/3.4.

CDISC SEND is an implementation of SDTM for nonclinical studies and specifies a consistent format for presenting and exchanging nonclinical data. The CDISC SEND implementation in PK Submit is compliant with the standards in the SEND Implementation Guide: Nonclinical Studies Version 3.0/3.1/3.1.1.

The CDISC ADaM implementation in PK Submit is compliant with the standards in the Analysis Data Model Implementation Guide Version 2.1.

For further information, please visit the Clinical Data Interchange Standards Consortium Web site at www.cdisc.org.

Note:    When updating the PK Submit Phoenix Plugin, be sure to uninstall the previous version of the Plugin before installing the newer version.

Data Preparation Wizard
Analysis Wizard
Slope Selector
Finalize PK Data
CDISC Data