From Startup to Launch in Just One Month, With Study Start-Up

Presented by

Meghan Donahue, Study Start-Up Product Owner, Remarque Systems & Andrea Ochoa, VP, Global Study Start-Up, Premier Research

About this talk

Start-up is a crucial time in any clinical study. It can also be chaotic. Developing protocols, choosing sites, onboarding patients—every step can have a profound impact that ripples through the length of the trial. Mistakes can take months to uncover—and then totally derail or significantly delay a trial. Although increasingly complex trial designs have led to increasingly complex start-up activities, more than 81% of operations teams still use spreadsheets to organize their study start-up. That’s time-consuming, susceptible to human error, difficult to troubleshoot, obstructive to regulatory compliance—and the need for multiple hand-offs creates a lack of immediacy that slows decision making. Remarque saw an opportunity to streamline the process. Its Study Startup (SSU) application automates collection of all trial data, then optimizes that data to decrease cycle times and intervals between steps. That minimizes errors and compresses timelines. Step-by-step, this webinar will explore how Remarque’s approach to SSU eliminates bottlenecks, improves quality and increases visibility. • Centralized document tracking supports collaboration • Workflow management highlights critical path items, helping prioritize tasks, meet timelines, and ensure consistency. • Built-in templates simplify country-specific regulatory compliance Finally, with a real world example, learn how SSU helped a large CRO move a crucial phase three trial to launch in less than a month.

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Premier Research is a clinical research company, dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments. As a global company, Premier specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors. Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.