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  1. Center for Drug Evaluation and Research | CDER

The KickStart service provides nonclinical reviewers receiving datasets in standardized (SEND) format with an assessment of data quality and a data exploration session. This helps reviewers better understand their data and have the information to conduct an effective evaluation of the drug submission.

Kickstart service provides: Preform data fitness checks, Identify key findings, Orientation to outputs and tools, Data exploration

KickStart Benefits and Impacts

KickStart is transforming the scientific and regulatory review process in several ways:

  • The KickStart data quality assessment and data exploration session helps the reviewer take advantage of standardized electronic data and leverage analytic capabilities.
  • The data quality assessment informs reviewers on conformance to the standard and the usability of the data to support regulatory review.
  • The data quality assessment allows reviewers to provide feedback to sponsors on the quality of SEND submissions.
  • KickStart provides reviewers an opportunity to explore modern tools and technologies to increase efficiency of review processes.

 

Most Common Issues with CDISC-SEND Data in FDA Toxicology Review

The KickStart Service provides data quality assessments to pharmacology and toxicology reviewers in the Office of New Drugs (OND).  The webinar covers several examples of substantive data quality issues FDA sees across studies.

Click the below icons to view a webinar or slides on Most Common Issues with CDISC-SEND Data in Toxicology Review.

For more information contact Office of Computational Science.

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