What happens when you tell the FDA "Monitoring my clinical trials is not your jurisdiction". The FDA is known for many things, but in the world of clinical trials, we know that if you F*** around, the FDA will find out. 

Episode 6 part 1 of Wild FDA audit stories. 

 In this episode, we uncover the shocking and often tragic history of clinical trials gone wrong. These cases exposed the dire need for ethical oversight in medical research. But from these dark moments came progress: the Belmont Report, informed consent, and strict regulations that protect patients today. Join us as we explore how past mistakes shaped the ethical frameworks that safeguard clinical trial participants now. 

Brittney is back with the Tea in STEM to discuss what she wished she knew as a new coordinator. 
Some common issues or struggles, and some ways to overcome them.

The FDA is known for many things, but in the world of clinical trials, we know that if you F*** around, the FDA will find out. 

Episode 5 of Wild FDA audit stories. 

 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. 

Brittney joins us again for another episode of Interview with a CRC. Today we discuss some of the common problems and issues facing new CRC's and lessons we wish we learned earlier on in our careers. 

Welcome back to Daniel, an accomplished CRA, as he tells us some of his horror site stories! 

Bonus:  Daniel discusses his side gig.

The CRA Coach - CRA Training, Clinical Research Associate Training

Join us as we interview Daniel, a CRA with an impressive career. Anna and Daniel discuss trials and tribulations of the CRA role and the training program Daniel has created to help support CRA's.

The CRA Coach - CRA Training, Clinical Research Associate Training