First-in-Human (FIH) Studies Cost: What Sponsors Need to Know

First-in-Human (FIH) studies are the critical first step in testing a new drug, therapy, or medical device in humans. While these trials generate essential safety, tolerability, and dosage data, they also represent a significant financial investment for sponsors.

The cost of FIH studies varies widely based on several factors, including study design, number of participants, trial duration, and the complexity of data collection. Expenses typically include site setup, patient recruitment, regulatory approvals, investigator fees, clinical monitoring, and data analysis. For medical device FIH studies, additional costs may arise from prototype development and specialized testing.

Partnering with an experienced Contract Research Organization (CRO) can help sponsors optimize budgets and streamline timelines. CROs leverage their expertise, established clinical site networks, and regulatory knowledge to reduce operational costs while maintaining high-quality data and compliance with global standards.

Investing wisely in FIH studies not only ensures patient safety but also accelerates the pathway to later-phase trials and ultimately, market approval. With careful planning and the right partners, sponsors can control costs while advancing innovation. Visit us: https://www.bioaccessla.com/bl....og/7-essential-first