Premier Insight
Dermatology

Premier Insight #288 | The path to approval: Achieving FDA clearance for a ground-breaking dermatology product

Across the United States, plaque psoriasis affects millions, often requiring patients to juggle multiple treatments for different areas of the body. But what if there was a single, breakthrough solution? This case study dives into how a pioneering biotech company, in partnership with Premier Research, set out to revolutionize plaque psoriasis treatment with an innovative product.

In this case study we go through:

  • How we managed two parallel phase 3 clinical trials across multiple sites while maintaining timelines and consistency.
  • Strategies for overcoming patient enrollment, compliance, and data integrity challenges, even during the COVID-19 pandemic.
  • Innovative remote monitoring and tracking tools and how they helped navigate disruptions during the pandemic.
  • Insights into the FDA approval process and the impact of effective collaboration in bringing a new dermatology product to market.