Aligned with CDER's 21st Century Review Process, JumpStart represents a first step in the creation of an integrated review environment that partitions work so data experts can focus on data fitness and exploratory safety analyses, and reviewers can focus on applying their clinical and scientific expertise to analyze study data to complete the review.
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
Exploratory 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.