Optimizing Adaptive Trials for Drug Development
Summary: Early clinical trials are becoming more complex as sponsors face rising regulatory requirements and the challenges of developing advanced drug candidates. Adaptive clinical trial designs offer a faster, more efficient path forward by enabling protocol modifications based on real-time data. When combined with on-demand clinical manufacturing, these flexible designs can help reduce development timelines, minimize manufacturing risk, and lower early-phase trial costs.
This executive summary explores how pharmaceutical and biotech companies can streamline Phase I studies through adaptive trial designs, real-time dose adjustments, and proactive regulatory strategies. Learn how integrating Catalent’s Xpress Pharmaceutics™ platform with a collaborative CDMO-CRO model accelerates IND timelines and improves clinical outcomes.
Download the executive summary to learn how adaptive trial design and on-demand drug product manufacturing can accelerate your path to clinic.