Background:
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Our client needed a workforce solution that would not only deliver difficult-to-find clinical talent, but also foster collaboration, provide scalability, and enhance retention.
The decision was made to consolidate a multi-supplier Clinical Operations workforce into a single-supplier, managed solution to increase retention and promote efficiencies in training, communication, and professional development.
The challenge:
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The main challenge that the sponsor was facing was that many of the studies were in different phases. This included one study that was a single/multiple ascending dose phase 1 study, and two other studies that were legacy and managed by a different vendor with different SDTM mapping approaches.
The solution:
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VGS developed pooled SDTM datasets from the studylevel SDTM datasets in order to generate the integrated ADaM datasets. These ADaM datasets were then used as a source to create the Tables, Listings and Figures. As Vita Global Sciences was the primary vendor for 6 of the 8 studies, and these were deemed “submission-ready.”
The outcome:
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After Vita Global Sciences was complete with this project, the sponsor was able to file the regulatory submission, as planned. Vita Global Sciences continues to work with the sponsor on regulatory response, as well as providing statistical programming on other clinical trials.
