The following are a selection of testimonials from regulatory clinical reviewers that describe JumpStart's effectiveness and efficiency.
“The analyses provided by JumpStart also enabled the review team to have a familiarity with this submission at the filing meeting and the review team was more prepared for the team meetings during the review cycle. This data familiarity, in turn, facilitated completion of preliminary analyses to key questions in advance of the midcycle meeting. These discussions helped the review team better understand gaps in the sponsor’s submission and to provide feedback on protocols that the sponsor had provided during the review cycle. Submission of these completed study results are currently being discussed as potential PMR/PMCs as part of the late-cycle communication.”
“The service gave me the opportunity to get an overall understanding of the quality of the submission and safety signals in a relatively short period of time and [allows] my further review [to be] more focused.”
“Allowed full confidence in data before review started, so did not need to perform independent checks.”
“Data fitness analysis overall was helpful and reassuring; the assessment of the appropriateness of AE coding was especially helpful.”
“JumpStart enabled me to get an overall understanding of safety results and guide my further analysis. MedDRA at a Glance, MAED, and JReview have been proven to be useful tool[s] for identifying particular safety issues.”