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  1. Office of Medical Products and Tobacco

Kickstart

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  image showing what kickstart service provides

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.

For more information contact Office of Computational Science.

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