Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission

While still in the early planning stages of a breast cancer clinical trial, the sponsor set out to proactively identify and mitigate potential risks that could derail the study before it even began. Two concerns stood out as particularly critical: the risk of costly protocol amendments during trial execution and the complexity of clinical trial regulatory submissions at the close of the study. Positioned at opposite ends of the clinical trial life cycle, both issues had the potential to significantly disrupt the sponsor’s aggressive development timeline if not addressed early.

Like many pharmaceutical companies, the sponsor recognized that clinical operations and clinical disclosure teams often operate in silos, limiting visibility and alignment across the trial continuum. This lack of integration can lead to inefficiencies, rework, and avoidable delays. To overcome these challenges, the sponsor turned to Citeline. Citeline’s integrated suite of solutions supports the entire R&D journey — from optimizing clinical trial design and improving patient engagement and recruitment strategies to streamlining clinical trial disclosure — enabling the sponsor to take a more connected, end-to-end approach to trial planning and execution.