Episode 08 - The Audit Advantage: Ensuring Trial Success with Elizabeth Nelson

Heart of the Trial

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Today we’re talking to Elizabeth Nelson, a powerhouse in the clinical research industry with over 25 years of experience in auditing, consulting, and training. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.

Her services have been requested by, and provided to, US federal agencies and military organizations, academic medical centers, industry Sponsors and Contract Research Organizations (CROs), Institutional Review Boards (IRBs), Clinical Investigators/clinical research facilities, and non-profit organizations. Buckle up for a thrilling conversation as we dive into the high-stakes world of clinical research compliance and hear jaw-dropping stories from Elizabeth’s career!

Highlights of the Episode:

• Meet Elizabeth Nelson: A clinical research quality expert, Elizabeth shares how she transitioned from a laboratory scientist to a clinical research auditor, driven by a passion for protecting patients and ensuring trial quality.
• Whistleblowing Wonders: Hear about the time Elizabeth and her team turned in a sponsor and two CROs to the FDA for unethical practices — a rare and courageous move in the industry!
• The Evolution of Clinical Quality: Learn how quality standards and auditing have transformed over the past two decades, and why independent oversight is more critical than ever.
• Auditor vs. Enforcer: Elizabeth reveals why she prefers to be a mentor rather than a “gotcha” auditor, emphasizing education over punishment to drive real change in clinical trials.
• Battling Bad Data: From finding identical blood pressure readings across multiple studies to uncovering falsified patient data, Elizabeth’s stories will leave you on the edge of your seat.

Key Takeaways:

• Protecting Patients First: Auditing is more than checking boxes; it’s about safeguarding the rights, safety, and well-being of trial participants.
• The Power of “Why”: Elizabeth’s work is rooted in a strong personal mission to ensure that research is conducted ethically and in the best interest of patients.
• Industry Shifts: The landscape of clinical trials is evolving, with more companies seeking mock audits and quality assessments upfront to avoid regulatory pitfalls.

Episode Highlights:

• [0:00] Suzanne introduces Elizabeth Nelson and her extensive experience in clinical research.
• [2:14] Elizabeth’s career journey from the CDC to clinical quality management.
• [5:35] The shocking story of turning in a sponsor and two CROs to the FDA.
• [11:21] Why training is often overlooked but critical in compliance.
• [14:43] When training isn’t the answer: Why audits matter.
• [20:56] Auditing IRBs and the complexities of ethical review oversight.
• [27:15] Hilarious (and horrifying) stories of poorly calibrated equipment and clueless staff.
• [36:30] Why consistency is key: Elizabeth’s mantra for maintaining quality in clinical trials.
• [42:19] Elizabeth’s advice for new auditors and the future of quality management.

📞 Connect with Elizabeth Nelson:

• Email: [e-mail]
• Phone: 304-6

📞 Connect with Suzanne:

• Website: https://www.iceconsultingllc.com/home
• LinkedIn: https://www.linkedin.com/in/turnersuzannem/

💌 Feedback and Questions:

• Email Suzanne at [e-mail]

🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!