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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!

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Building Clinical Research Careers – with Rudy Malle

Show Description & Notes

What if the key to industry growth wasn’t just talent—but career navigation?

In this episode, Suzanne talks with Rudy Malle, founder of YANA Career Consulting and the Clinical Research Accelerator, about how his unconventional path through the clinical research world—from medical assistant to site director to career strategist—is helping others break in and move up.

They cover:

• Rudy’s 360-degree view of clinical trials from site, sponsor, and CRO perspectives
  
  
• The power of curiosity, adaptability, and asking the right questions
  
  
• Why bridge programs matter and how they help diversify the industry
  
  
• The disconnect between job requirements and real-world experience
  
  
• The importance of mentorship, networking, and mindset in career growth
  
  
• How Rudy is helping job seekers translate transferable skills into clinical research roles
  
  

📘 About the Guest
 Rudy Malle is a career strategist and clinical research expert with over 15 years of experience spanning clinical research sites, academic institutions, pharma companies, and CROs. As the founder of YANA Career Consulting and creator of the Clinical Research Accelerator, Rudy helps professionals transition into and thrive in clinical research careers through strategic coaching, mentorship, and training programs. He is passionate about empowering job seekers and career changers to confidently navigate their career journeys and achieve success in the life sciences industry.

📍 Connect with Rudy Malle
LinkedIn: https://www.linkedin.com/in/rudymalle/
Website: www.yanacareers.com

Email: [email protected]

📞 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!

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Breaking Barriers in Biotech with Suzanne Vyvoda.

From CRC to clinical exec—how betting on yourself can reshape an industry.

In this episode, Suzanne Turner sits down with biotech executive and clinical trial strategist Suzanne Vyvoda to trace her incredible 20+ year journey through the clinical research world. From learning on the fly as a site coordinator to leading clinical operations at top biotech companies, Suzanne shares how she’s navigated pivots, silos, and the ever-changing landscape of drug development.

We talk about:

• Her transition from site to CRO to sponsor
• Why cross-functional empathy is essential in clinical trials
• The rise of fractional leadership in biotech
• How she’s using LinkedIn to build transparency and connection across the industry
• The power of saying yes to yourself—even when the path isn’t clear
  
  

💬 About the Guest

Suzanne Vyvoda is a biotech executive and clinical trial strategist with over 20 years of experience leading development operations across pharma and emerging biotech. She’s advanced programs from IND through pivotal trials in oncology, immunology, infectious disease, and rare diseases, holding senior roles at organizations including Gilead, AbbVie, and Telavant.

She now leads Vyvoda Consulting, offering fractional leadership and strategic support to sponsors and biotech-adjacent companies, and mentoring emerging leaders—especially women—through big career transitions. Passionate about breaking silos in research, Suzanne champions cross-functional collaboration with the patient as the north star.

📍 Connect with Suzanne Vyvoda
 Email: [email protected]
 LinkedIn:linkedin.com/in/suzanne-vyvoda/

📞 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!

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Designing Trials that Actually Work—with Dr. Noah Goodson

What happens when you approach clinical research like a scientist, a strategist, and an entrepreneur—all at once?

In this episode, Suzanne sits down with Dr. Noah Goodson,  Principal, Strategy & Advisory  at THREAD, to talk about how smarter study design and better technology can dramatically improve trial execution, patient experience, and data quality. Noah shares how he went from retinal neuroscience to rethinking decentralized trials—and why the best clinical strategies are rooted in empathy.

We talk about:

• What endpoints really are and why they matter
• Common design missteps (like forgetting who’s actually entering the data)
• How innovative sponsors are boosting recruitment and compliance
• Why protocol isn’t enough—you also need a plan that works in real life
• Advice for newcomers trying to break into clinical research
  
  

📘 About the Guest:

Noah Goodson, PhD
Principal, Strategy & Advisory

Noah Goodson, PhD, is the Principal, Strategy & Advisory at THREAD, a leading eClinical technology solution for eCOA and Decentralized Trials. He designs and deploys clinical trials that work for every user, ensuring studies are accessible, engaging, and deliver high-quality data. 

📍 Connect with Noah
 LinkedIn:https://www.linkedin.com/in/noahgoodson/

📞 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!

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The history of human research isn’t just in the past—it’s in every consent form, every protocol, every rule we follow today.

In this solo kickoff to Season 2, Suzanne takes us on a powerful and personal journey through some of the most defining—and devastating—events in research history. From the Nazi experiments and Tuskegee study to the story of Henrietta Lacks, this episode confronts the ethical failures that led to today’s clinical trial safeguards.

We’ll explore how these moments shaped modern practices around:

• Informed consent
• Independent oversight (like IRBs)
• Vulnerable population protections
• Post-marketing surveillance

Whether you’re in the clinical research world or simply curious about what really drives ethical standards, this episode offers both context and heart.

📚 References and Further Reading:

• The Nuremberg Code
• Willowbrook Hepatitis Studies
• Jewish Chronic Disease Hospital Study
• Tuskegee Syphilis Study
• Henrietta Lacks – The Immortal Life
• Jesse Gelsinger Case
• Thalidomide Tragedy
• Vioxx Withdrawal
• Belviq
• Zantac Recall

💬 Feedback welcome!
 Let me know what resonated—or if you'd like to hear more episodes like this. Email me anytime at [email protected] or connect at https://www.iceconsultingllc.com/.

📞 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!

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Today’s episode of Heart of the Trial is all about the true heart of clinical research—the patients. Joining me is the brilliant Pauline Frank, who has spent years bridging the gap between clinical trial teams and patient advocates. If you’ve ever wondered how to improve patient engagement in clinical trials or why it’s so important, this episode is for you!

Highlights of the Episode:

• Meet Pauline Frank: A passionate advocate for increasing patient engagement in clinical trials, Pauline shares her journey and explains why getting patients involved early in the process is key to the success of studies.
• Breaking the Norm: Pauline discusses how traditional clinical trial designs often miss the mark by not incorporating patient feedback and how this leads to recruitment delays and high dropout rates.
• Changing Perceptions: There’s a common fear among trial teams that engaging with patients will slow things down or increase costs. Pauline breaks down why these concerns are often misconceptions and how true patient involvement can actually save time and money.
• Lessons from the Field: With over 17 years in the industry, Pauline shares eye-opening stories about how listening to patients has improved trial outcomes and reduced recruitment challenges.

Key Takeaways:

• The Power of Patient Voice: When patients are included in trial design and execution, recruitment rates improve, and dropout rates decrease—ultimately speeding up the entire trial process.
• Building Bridges: Pauline emphasizes the need for clinical teams and patient advocates to communicate better and start collaborating from the very beginning of the trial.
• Taking Small Steps: You don’t need to overhaul your entire system to start improving patient engagement—Pauline’s advice is to start small and learn as you go.

Episode Highlights:

• [0:01] Suzanne introduces Pauline Frank and the topic of patient engagement.
• [2:09] Pauline explains the misconceptions around the costs and delays of involving patients.
• [6:15] The reality of why 80% of trials face recruitment delays and how patient engagement can help.
• [11:22] Why getting patients involved early can save time and money in the long run.
• [18:00] Pauline shares success stories of trials that incorporated patient feedback.
• [24:40] The importance of education and communication in bridging the gap between patient advocates and clinical teams.
• [30:20] Pauline’s advice for anyone looking to improve patient engagement: “Start small and learn as you go.”

📞 Connect with Pauline Frank:

• LinkedIn: Pauline Frank
• Email: [email protected]

📞 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!

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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: [email protected]
• 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 [email protected]

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

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Today we’re diving into the exciting world where genetics meets pharmacology. Dr. Emily Cicali will uncover the mysteries of pharmacogenomics (PGX) and explain how your DNA influences your response to medications. Get ready for insights, real-world applications, and a touch of scientific magic!

Emily J. Cicali, Pharm.D., earned her Doctor of Pharmacy from Philadelphia College of Pharmacy in 2015. She completed a Pharmacy Residency at Tabula Rasa HealthCare in Geriatric Personalized Medicine. Afterward, she joined Tabula Rasa HealthCare as a Research Pharmacist and adjunct faculty, focusing on pharmacokinetics and pharmacogenomics.

In 2017, she transitioned fully into academia, completing a pharmacogenomics fellowship at the University of Florida. Cicali is now a Clinical Associate Professor, runs a virtual pharmacogenetics consultation service called MyRx, and focuses on implementing pharmacogenomics and studying phenoconversion for medication safety.

Highlights of the Episode:

• Pharmacogenomics 101:  Discover how this DNA test focuses on liver enzymes to predict your response to medications.
• Why It Matters:  Learn how understanding your genetics can reduce trial-and-error in prescribing, especially for depression and anxiety.
• Emily’s Journey:  Follow Emily’s path from a student fascinated by genetics to an expert in PGX, highlighting her passion and success.
• Clinical Research Impact:  Hear about Emily’s role in clinical trials and how PGX testing is improving patient outcomes in pain and mental health management.

Key Takeaways:

• Personalized Medicine: Understand the importance of personalized medication therapy and how PGX can help tailor treatments to individual patients for better efficacy and fewer side effects.
• Real-Life Applications: Learn about the real-world implications of PGX testing, from reducing opioid use in pain management to improving outcomes for heart attack patients.
• Patient Empowerment: Emily emphasizes the role of PGX in empowering patients by giving them more control over their healthcare and improving communication with providers.

Episode Highlights:
[0:54] Emily explains pharmacogenomics and its significance.
[2:09] The benefits of knowing your genetic makeup before starting medication.
[3:25] Emily’s career journey and her passion for genetics and pharmacy.
[6:34] How PGX testing is integrated into clinical practice at MyRx.
[10:54] Emily’s experience in clinical research and the impact of PGX on patient outcomes.
[17:39] The mechanism of drug metabolizing enzymes and their role in medication efficacy.
[20:23] How to discuss PGX testing with your doctor and insurance considerations.
[26:08] Real-life success stories and patient experiences with PGX.
[30:26] Emily’s hopes for the future of PGX and its broader implementation in healthcare.
[36:43] Resources and advice for listeners interested in PGX testing.

📞 Connect with Dr. Emily Cicali:
Website: https://ufhealth.org/myrx/ 
Email: [email protected]
Phone: 352-273-6415
LinkedIn: https://www.linkedin.com/in/emily-cicali-pharmd-2164b2a4/

📞 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!

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In today’s episode of Heart of the Trial, we’re turning the spotlight on the hilarious and insightful Christine Kanalis, who boasts over 25 years of experience in data management. Get ready for a fun and enlightening dive into the world of clinical trial data! 

 Highlights of the Episode: 

• Meet Christine Kanalis: With a background in statistics and a knack for humor, Christine takes us through her fascinating journey in the clinical trial industry.
• Data Management Magic: Learn what it means to gather, clean, and analyze clinical trial data, and why it’s crucial for the success of any study.
• Unexpected Origins: From dreaming of working in a steel mill to discovering a passion for biostatistics, Christine’s career path is anything but ordinary.
• The Human Side of Data: Discover how Christine’s work impacts the lives of patients, and why she’s so passionate about ensuring the accuracy and integrity of clinical trial data.
• Tech Evolution: Christine shares amusing and eye-opening stories about the evolution of data collection, from floppy disks to cloud storage.

Key Takeaways: 

• The Importance of Data Integrity: Understand why accurate and complete data is essential for the approval of new drugs and treatments.
• Behind the Scenes: Get a peek into the challenges and triumphs of data management, including the sometimes-frantic efforts to keep technology running smoothly.
• Inspiring Journeys: Christine’s story is a testament to the power of passion and adaptability in building a rewarding career.

Episode Highlights: 

• [0:01] Suzanne welcomes listeners and introduces Christine Kanalis.
• [0:25] Christine’s hilarious introduction and her role in data management.
• [1:57] Christine’s journey from a budding mathematician to a director in data management.
• [6:24] The pivotal moment in Christine’s career that made her fall in love with biostatistics.
• [10:50] The evolution of data collection methods over the past 25 years.
• [17:03] The critical role of statisticians and data managers in clinical trials.
• [26:47] Christine’s “why” and what keeps her motivated in the industry.
• [30:19] A heartwarming story of a successful study and its impact on patients.
• [35:11] Christine’s advice for those interested in a career in data management.
• [44:18] Christine’s podcast, The Mental Funny Bone, and where to connect with her.

📞 Connect with Christine: 

• Email: [email protected]
• LinkedIn: https://www.linkedin.com/in/christine-kanalis-5151832/
• Podcast: The Mental Funny Bone https://thementalfunnybone.buzzsprout.com/

📞 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!

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Today we're diving into the fascinating world of clinical trial data management with none other than software expert Sam Rolfe. This episode is a rollercoaster ride through the complexities and innovations in managing the documents and data of clinical trials. Buckle up for an insightful and fun discussion!

In this episode, Sam shares his journey from a sports science degree to becoming a key player in the world of clinical trial data archiving. Discover how the evolution of technology has transformed the way we store and manage critical clinical data, ensuring it remains accessible and usable for decades. Sam and Suzanne discuss the importance of regulatory compliance, the risks of outdated storage methods, and the future of decentralized trials.

Having spent the last 12 years working with SaaS Solutions built for Biotech, Pharma and CROs – Sam has experience in software delivery (project management and implementation), pre-sales and full end-to-end sales of both individual applications and platform solutions. He is passionate about how 'true cloud' SaaS solutions help drive Life Sciences companies to bring drugs and devices to patients faster; with greater efficiency, safety and compliance, while reducing the overall cost of development.

Highlights include: 

• Sam’s accidental entry into the industry and his passion for making a difference.
• The challenges and importance of archiving clinical trial data for the long term.
• Real-life stories about outdated storage methods, including CDs and DVDs, and the risks they pose.
• The impact of COVID-19 on clinical trials and the rise of decentralized trials.
• Why proper data management and system validation are crucial for the safety and efficacy of new drugs.

Sam also reveals some hilarious and eye-opening anecdotes, like the tale of a clinical trial participant using their dog to cheat step count data. This episode is packed with valuable insights, humor, and a genuine passion for improving patient outcomes through better data management.

So, grab your headphones and join us for a deep dive into the techy side of clinical trials. Whether you're an industry insider or just curious about the behind-the-scenes magic that brings new treatments to market, this episode has something for everyone.

✨ Episode Highlights:

• [0:01] Suzanne's intro and welcoming Sam Rolfe.
• [0:30] Sam's background and the importance of archiving clinical trial data.
• [4:00] The risks of outdated storage methods and the transition to electronic systems.
• [10:00] The impact of COVID-19 on clinical trials and the rise of decentralized trials.
• [14:00] Validation of systems and why it's critical for regulatory compliance.
• [20:00] Fun and unexpected stories from the world of clinical trials.
• [30:00] Sam’s advice for new biotech companies entering the clinical trial arena.
• [40:00] Suzanne and Sam wrap up with a discussion on the importance of communication in the industry.

📞 Connect with Sam: 

• LinkedIn: https://www.linkedin.com/in/sam-rolfe
• Email: [email protected]

📞 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!