The underlying goal of using master protocols is to increase efficiency and expedite drug development for critical unmet needs. With the US Food and Drug Administration encouraging creativity in trial designs through newly introduced regulatory guidance, it is important for all stakeholders (sponsors, clinical research organizations and vendors) to adapt their processes and ensure medicines are delivered to patients, faster.
In this white paper, 4G Clinical discusses the different types of master protocol studies, addresses the complexities that come with these types of study design, and explores how technology – specifically modern randomization and trial supply management (RTSM) solutions – are critical to run flexible, robust and quality-driven trials.
Download this white paper to learn:
- What are master protocol trials and what are the related global agency regulations.
- Which study type best fits with your clinical trial design.
- How to solve the key challenges of executing master protocol studies.
- Why a modern, configurable RTSM system can help overcome unique processes and quality challenges.
Download your copy now to innovate your clinical trial design.
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