The Tea in STEM

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

Not all Scientists match the image of a nerdy, pocket protector wearing, loner, in fact, sometimes they are the ones throwing the biggest parties.

The Happy Accident of how both the understanding and treatment for ED changed.

Join us as we share some stories written in about CRA's that were not so ethical in their practices.

Today we discuss the story of the father of Gastroenterology and his early experiments. TW: Graphic wounds verbally described

Brittney Joins us again to discuss some of the hardships of the CRC role. We talk about sponsor/CRC communication, PI involvement, and some of the struggles in recruitment.

Ever wonder what happens to devices/IP after it leaves the site? Join us as we discuss FDA Audits with J, who has experience with FDA audits in medical device manufacturing, and how these differ from pre-approval research audits.

Bigfoot- the Myth and Legend and the Scientist who gave up his social standing to try to prove its existence.

CRA Horror stories, Catching the bag guy before the FDA does. This Coordinator was caught by their CRA enrolling an ineligible patient as a birthday gift to their boss.

Majority of STEM fields are male dominated, but how close is social media to real life of a new woman entering the STEM field. Join us for Interviewing Carmen, a Project Manager in Construction.

Friendship between scientists that lead to one of the biggest fall-outs in history and also some of the biggest discoveries.

Physicians taking on too much, when it rains it pours, how to handle a divorce and FDA audit at the same time.

Join us for our first interview with a Clinical Research Coordinator. On this episode we discuss Sponsor/Pharma involvement and communication with the site and the inclusivity of technology for patients with diverse backgrounds.

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