IN PARTNERSHIP


and more unified analysis – was critical to the study’s success, the company began looking for a better solution. Following an evaluation of multiple vendors (including ones it worked with previously), the pharmaceutical company chose Prevail’s innovative solution for several reasons. In terms of visibility, this approach provides


a single, unified view with detailed reporting, analytics, and visualisations encompassing clinical and operational data within and across studies – from all data sources including EDC, CTMS, labs, imaging, ECG, safety, IRT, ePRO and more. It offers early observations with access to live study data, without breaking the blind or requiring alpha-spend, and is aligned with a company’s business processes without time and programmers standing between the sponsor and its patients’ data – allowing researchers to apply their experience to adjust data parameters on the fly and see the results immediately. For data reporting, it overlays and integrates


data from any existing internal systems as well as external ones provided by CROs and other service providers in any format, it fully automates the data extraction process, independent of whether a system supports APIs or SFTPs, and can be set up in just 4-6 weeks, regardless of system and study complexity.”


The results exceeded expectations, freeing the Pharma company’s clinical research team from their time-consuming manual effort and providing them with tools to gain unique insights from the study data. The Phase II met its endpoints and was accepted as a pivotal study by the FDA based in part on the quality of the data, allowing the company to conduct a single Phase III study instead of the usual two – saving months of effort and an estimated $20 million in development costs. The rolling submission time of the company’s New Drug Application was accelerated by weeks and the cost and effort reduced because the patient profiles containing all stdy data collected for an individual patient organised by time), and other data needed for the required patient narratives was auto-generated from Prevail’s platform. During the Phase II study, the clinical research team discovered an unlooked-for and promising new drug indication in the data. This allowed the company to accelerate the new


indication into a Phase II study by leveraging the body of work in the other indication for the same molecule. Whether it’s a Phase II being pivotal or a Phase I that sheds cohorts that aren’t responding, a database that locks datapoint- by-datapoint as the study is ongoing can save you months and save you millions.


For more information on Prevail InfoWorks, visit prevailinfoworks.com, reach out to info@prevailinfoworks.com, or call +1(267)797-2001.


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