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  1. Drug Information for Consumers

How JumpStart Works

JumpStart represents a critical step in the creation of an integrated review environment that allows data experts to support data quality assessments and enables regulatory reviewers to focus their safety analyses.

The data fitness portion of the JumpStart service helps reviewers:

  • Assess clinical trial data quality

  • Determine what types of analyses can be performed and what review tools can be used

  • Identify where there are gaps or inconsistencies in the data that may have an impact on the review

Safety analyses give reviewers:

  • A global view of the safety profile of a drug

  • Insight to areas that may warrant further analysis during the review process

The table below describes key JumpStart functions and their purposes, and the corresponding benefits. 

Purpose

 

Benefits

1. Assess and report on whether data is fit for purpose

  • Quality
  • Tool loading ability
  • Analysis ability
1. Understand data, analyses that can be performed, and identify potential information requests for the sponsor
2. Load data into tools for reviewer use and run automated analyses that are universal or common (e.g., demographics, simple AE) 2. Improves the efficiency of review by setting up tools and performing common analyses, which provides time to focus on more complex analyses
3. Provide analyses to highlight areas that may need a focus for review 3. Points to a possible direction for deeper analysis

 

More Information on JumpStarting Drug Review

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