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Today, we dive into the nitty-gritty world of clinical trial compliance with our fabulous guest, Teresa Davis, who brings over 15 years of experience to the table. If you’ve ever wondered about the behind-the-scenes magic that keeps clinical trials running smoothly, this episode is for you!

In this episode, Teresa shares her journey from an English and art background to becoming an Associate Director of Clinical Operations, specializing in clinical compliance. Inspired by her sister and motivated by her niece’s life-saving clinical trial, Teresa's path into the industry is both heartwarming and inspiring.

Teresa’s passions within the industry are Site Monitoring, Risk-based Quality Management (RBQM), Clinical Compliance, and Vendor Governance. She is currently an Associate Director (contractor) of Clinical Operations within a ClinOps Compliance Team.

She is a wife and mother to two children: a son, and a daughter. She spends her time outside of work shuttling kiddos to taekwondo, t-ball, and gymnastics events. Her husband is a full-time football coach.

Highlights of the Episode:

• Teresa’s introduction to clinical research through her sister and the Healthcare Business Women's Association.
• The life-changing impact of her niece’s participation in a clinical trial for pulmonary arterial hypertension.
• Teresa’s deep dive into risk-based monitoring (RBM) and risk-based quality management (RBQM).
• The role of a Clinical Research Associate (CRA) and the transition from paper to electronic medical records.
• Insights into the importance of compliance, quality processes, and regulatory adherence in clinical trials.
• Fun and informative stories about working with cutting-edge technologies like oncolytic viruses and genetically modified organisms.

Key Takeaways:

• Understanding Compliance: Learn about the compliance funnel that blends regulations, company SOPs, and protocols to ensure patient safety and data integrity.
• The Power of Data: Discover how risk-based monitoring and quality management improve clinical trial efficiency and safety.
• Career Pathways: Teresa’s advice for aspiring professionals includes certifications, joining CRA programs, and building a robust LinkedIn profile.
• Networking and Growth: The importance of networking, volunteering, and staying updated with industry changes to advance your career in clinical research.

Episode Highlights:

• [0:01] Suzanne’s enthusiastic welcome and introduction of Teresa Davis.
• [0:30] Teresa’s career journey and the pivotal moments that shaped her path.
• [2:00] A deep dive into risk-based monitoring and quality management.
• [10:00] The transition from paper to electronic systems in clinical trials.
• [18:00] The importance of compliance, training, and documentation.
• [30:00] Teresa’s advice for breaking into the industry and growing your career.
• [40:00] Exciting advancements in personalized medicine and clinical research.

📞 Connect with Teresa:

• LinkedIn: www.linkedin.com/in/teresasuedavis
• Email: TeresaSueDavis08@Gmail.com

📞 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!

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Join the always energetic Suzanne Turner as she dives into the intricate world of drug safety with industry veteran Janet Cummins! With over 20 years of experience, Janet shares her journey from a high school vocational tech class to becoming a director in pharmacovigilance. Get ready for a whirlwind tour of what really goes on behind the scenes in clinical trials.

Janet brings a wealth of knowledge and a healthy dose of humor to topics like adverse events, regulatory requirements, and the unexpected twists and turns in drug development. Did you know that a hypertension study led to the creation of Viagra? Or that some participants in trials have had their stool samples sent all the way to Switzerland? These are just a few of the fascinating stories you'll hear.

In this episode, Suzanne and Janet discuss:

• The nitty-gritty of drug safety and pharmacovigilance.
• Janet’s unconventional path into the industry and her passion for ensuring drug safety.
• The importance of regulatory bodies like the FDA and their impact on clinical trials.
• Hilarious and surprising moments from Janet’s extensive career, including a clinical trial involving gas collection in jars!

Whether you're an industry insider or just curious about the human side of healthcare, this episode is packed with insights and entertainment. Janet’s enthusiasm and Suzanne’s engaging hosting style make for a compelling listen that sheds light on the dedicated professionals working tirelessly to ensure the safety of new medications.

So, buckle up for an informative and fun ride through the trials and tribulations of clinical research. Tune in to discover the heart of the trial!

✨ Episode Highlights:

• [0:02] Suzanne welcomes listeners and introduces Janet Cummins.
• [1:20] Janet’s career journey and the role of pharmacovigilance.
• [10:35] Real-life anecdotes from clinical trials.
• [18:50] The evolution of drug safety and its regulatory framework.
• [30:00] Hilarious trial stories – from fart jars to unexpected drug effects.
• [45:15] Closing thoughts and contact information for Janet Cummins.

📞 Connect with Janet:

• Email: Janet@JanetLKoontz.com or KoontzJL@gmail.com
• Linkedin: https://www.linkedin.com/in/janetlkoontz/
• Phone: 619-895-5439

📞 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!

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Hello, lovely listeners! In a delightful twist, today’s episode of Heart of the Trial flips the script as Suzanne Turner, your beloved host, becomes the guest! Guest host Phil Pelucha from Billionaires in Boxes takes over to interview Suzanne, revealing the heart and soul behind the podcast.

Highlights of the Episode:

• Role Reversal: Phil Pelucha takes the reins, bringing a fresh perspective to the show as he interviews Suzanne.
• Heart of the Trial’s Mission: Suzanne shares her vision for the podcast, aiming to bring positivity to the pharmaceutical industry and highlight the passionate individuals working behind the scenes.
• Personal Journey: Discover Suzanne’s unique path into the clinical trial industry, from a travel agent to a TMF (Trial Master File) specialist, and how a leap of faith led her to a rewarding career.
• The Importance of TMF: Learn about the crucial role of the Trial Master File in clinical research and why documentation is key to the success of clinical trials.
• Bridging the Gap: Suzanne discusses the challenges and improvements in the industry, emphasizing the importance of understanding and collaboration between sponsors and CROs.
• Inspiring Positivity: Despite the negative perceptions often associated with the pharmaceutical industry, Suzanne highlights the good and the dedicated professionals striving to make a difference.

Key Takeaways:

• Transparency and Trust: Understand the importance of transparent documentation and how it impacts the success of clinical trials and drug approvals.
• Advocacy and Impact: Suzanne’s passion for advocating within the industry and her hope to inspire others by showcasing the positive aspects and dedicated individuals in clinical research.
• Educational Insight: Gain insights into the various roles within clinical trials, the significance of the TMF, and the challenges faced by professionals in the field.

Episode Highlights:

• [0:03] Phil introduces the episode and takes on the role of guest host.
• [0:30] Suzanne shares her motivation behind Heart of the Trial and the importance of showcasing the positive side of the pharmaceutical industry.
• [4:35] Suzanne’s accidental entry into the industry and her journey from a travel agent to a TMF Subject Matter Expert.
• [7:15] The role and significance of the Trial Master File in clinical research.
• [10:50] The evolution and challenges within the industry, including sponsor oversight and electronic TMFs.
• [18:00] Suzanne’s vision for the podcast and the types of guests and stories she hopes to feature.
• [27:00] Phil and Suzanne discuss the public perception of the pharmaceutical industry and the impact of COVID-19.
• [32:07] Suzanne’s final thoughts on the goals of Heart of the Trial and her hopes for the audience and guests.

📞 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!