The transition from preclinical to clinical testing is a pivotal moment in drug development. It’s also one of the most challenging development milestones, beset by unknown risks, unexpected data, and potential regulatory hurdles to overcome. In this article, Quotient Sciences experts discuss how proper planning can avoid missteps in first-in-human studies, looking at trial design, CMC, and regulatory considerations.
Quotient Sciences is dedicated to Phase I trials and early drug development, providing the insights you need by offering comprehensive clinical pharmacology services for all Phase I study programs. Our services encompass expert clinical study design, thorough data analysis, and detailed reporting. With our fully integrated approach, we ensure seamless execution and deliver high-quality results safely and quickly.
Partnering with an experienced first-in-human specialist such as Quotient Sciences is the key to navigating early development with confidence. Through our work with small molecules and biologics, we provide the expertise, infrastructure, and agility needed to move your novel therapy forward, faster.
Dr. Andreas Reichl, Senior Drug Development Consultant, and Dr. Kevin Schaab, Senior Drug Development Consultant, both from Quotient Sciences, present a practical breakdown of how early-phase experts design programs to mitigate risks and efficiently move novel molecules into PoC assessments.