In this episode of Tea in STEM, we're joined by Nikki Jundt, a seasoned regulatory specialist, to delve into the complexities of Investigator Site File (ISF) maintenance. Nikki shares her expertise and highlights critical challenges faced by research sites, drawing from her recent experience on a CDISC conference panel alongside FDA auditors and CRO representatives. This episode discusses DOA regulations, Re-consenting issues, SUSAR management and Central document distribution. Tune in to uncover how to navigate the evolving regulatory landscape with confidence!

In Part 2 of our discussion on the FDA’s new guidance for clinical trials, we move from theory to practice. Ted B. from Medvector joins us again to dive into solutions for addressing potential challenges when implementing this new flexibility allowing healthcare providers (HCPs) to conduct visits with Principal Investigator (PI) oversight.

In this episode, we dive into the latest FDA guidance expanding flexibility for clinical trials by allowing healthcare providers (HCPs) to conduct visits under Principal Investigator (PI) oversight. What does this mean for patients, research sites, and sponsors? Join us as we sit down with Ted Barduson, COO and Co-founder of Medvector to discuss the practical implications of this groundbreaking change. From improving patient access and engagement to navigating oversight and compliance, we explore how this new guidance can reshape the clinical trial landscape. Tune in for insights and actionable tips to put this into practice at your site.