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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 [email protected]

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