Streamlined Site Study Start-Up: Key Components, Perspectives And Research-Based Insights

Explore the critical process of Study Start-Up (SSU) in clinical trials, with an emphasis on the collaborative efforts of sponsors and research sites to enhance efficiency and reduce timelines. From the sponsor's perspective, effective feasibility assessments and site selection are foundational, with the Shared Investigator Platform (SIP) significantly streamlining these processes by reducing redundancy and cutting assessment times. Budget and contract negotiations, often the most time-consuming aspect of SSU, can be expedited through standardized agreements like the Accelerated Clinical Trial Agreement (ACTA) and the use of AI-driven tools such as TrialPro, which simplify budget creation and provide real-time benchmarks.

Regulatory package completion is also streamlined via SIP, allowing for faster submissions and site activations. The article highlights the advantages of central Institutional Review Boards (IRBs) and the benefits of parallel submissions to further reduce activation times. It concludes that while achieving a universal "90-day activation" remains a challenge, advancements in technology and process standardization are paving the way for more efficient SSU, ultimately facilitating quicker access to new therapies for patients.