Heart of the Trial
Welcome to a podcast delving into the personal narratives within the clinical research industry. Through candid interviews, we'll learn about the personal journeys and motivations of individuals who have chosen this profession. What I like to call 'their why'.
My aim is to spotlight the often overlooked heroes of clinical trials, showcasing their passion and dedication that extends beyond the spotlight of 'big Pharma.' These conversations will illuminate the heartfelt narratives of those driving advancements in medical research.
This podcast is not just for industry insiders; it's for everyone curious about the human side of healthcare. Beyond the industry's negative reputation, we'll shed light on the dedicated professionals behind clinical trials.
Join us as we uncover the heart and passion of those working tirelessly behind the scenes in clinical research. Welcome to Heart of the Trial!
Heart of the Trial
Season 2, Episode 5: The Heart of the TMF with Ann Ackley-Fifer
The Heart of the TMF with Ann Ackley-Fifer
Show Description & Notes
What started in a file room became a 20-year journey of transforming how trials are documented, connected, and inspected.
In this episode, Suzanne sits down with fellow TMF expert Ann Ackley-Fifer to talk about her evolution from paper-based Trial Master Files to digital strategy, system configuration, and end-user empowerment. Ann shares what’s changed in the last two decades of TMF management—and what hasn’t.
Together, we cover:
- How paper roots shaped Ann’s digital TMF philosophy
- Common misconceptions that still slow teams down
- What E6(R3) means for sponsor oversight and CRO transparency
- Why end-user understanding is the hidden key to TMF quality
- What keeps Ann passionate after nearly 20 years in the field
📘 About the Guest
Ann Ackley-Fifer’s TMF journey began in 2006. With experience at CROs, sponsors, and now as a consultant, she’s witnessed the evolution from paper to digital—and everything in between. Her philosophy centers on user-friendly systems and practical training, ensuring that TMFs aren’t just compliant, but clear and usable. A Veeva-certified expert and TMF consultant for the past four years, Ann believes even the best system fails without empowered users.
📍 Connect with Ann Ackley-Fifer
LinkedIn: https://www.linkedin.com/in/annackleytmfsme/
(Yes, she’s the one with the awesome blue hair.)
📞 Connect with Suzanne:
- Website: https://www.iceconsultingllc.com/home
- LinkedIn: https://www.linkedin.com/in/turnersuzannem/
💌 Feedback and Questions:
- Email Suzanne at podcast@iceconsultingllc.com
🎙️ Tune in and get to know the passionate professional behind Heart of the Trial!