Beyond The Protocol
Successful clinical trials aren't just about processes and protocols - they're about the empowered teams and supportive cultures behind them.
Beyond the Protocol is a live show and podcast where Melody Keel brings together diverse professionals across the clinical research landscape: from operations teams to industry experts, all sharing insights on what it takes to deliver successful clinical trials
We dive deep into the human side of clinical trials, exploring everything from team dynamics to operational challenges, leadership development to cultural transformation.
Each episode features authentic conversations with industry professionals who understand that true excellence in clinical research starts with supporting the people who make it happen.
Ready to discover how empowered teams drive exceptional trial outcomes?
Join us as we go Beyond the Protocol, where we believe that investing in people is the key to clinical trial success.
Episodes
18 episodes
Where Does Trust Begin in a Clinical Trial?
In clinical trials, trust isn’t a soft skill it’s the foundation of everything. But trust doesn’t just happen between patients and sponsors. It begins with the teams who run the trials. Without strong leadership, mentorship, and ong...
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How Do You Turn Training into a Leadership Pipeline?
What if your training programs didn’t just meet compliance—but built your next generation of leaders?In this episode, Melody Keel sits down with Celeste Brantolino, Senior Director at Exela Pharma Sciences and a 2...
When Leadership Looks Like Us
Building Representation Into the Trial Clinical research can’t scale without inclusive leadership. In this episode, Melody sits down With Danielle S. Mitchell founder of Black Women in Cl...
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Redefining Access
What Clinical Teams Miss About Patient Recruitment Equity in clinical trials isn’t about checking a diversity box, it’s about changing how we think, lead, and communicate. In this episode featuring
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When a Trial Saves Your Family
Why Inclusion Must Be Intentional Clinical trials aren’t just about data, they’re about people. For Denise N. Bronner, Ph.D., that truth became deep...
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De-Risking Clinical Trials: What High-Performing Teams Get Right
Many clinical trials fail quietly. Not due to flawed science, but because of burnout, leadership gaps, and misaligned execution. In 𝗘𝗽𝗶𝘀𝗼𝗱𝗲 𝟮 of 𝗕𝗲𝘆𝗼𝗻𝗱 𝘁𝗵𝗲 𝗣𝗿𝗼𝘁𝗼𝗰𝗼𝗹, we’re thrilled to be joined by
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AI Is Here …Now What? Evolving Teams & Training in Clinical Research
AI in clinical research isn’t just changing how trials are run, it’s reshaping the roles, skills, and support teams need to succeed. In this pilot episode of Season 2, Melody Keel explores how clinical operation...
Beyond the Protocol: Insights That Shaped Season One
As we close out season one of Beyond the Protocol, this special finale captures the collective wisdom, passion, and hard-earned truths shared by clinical research leaders who are reimagining how trials are designed, led, and del...
Fixing the Disconnect: Why Clinical Tech Fails Without Operational Clarity
Clinical trials don’t derail because of technology alone—they fall short when people aren’t equipped with the tools needed to meet real-world demandsIn this episode, Melody Keel sits down with Jason Spivey...
From Pipeline to Patient: Humanizing Business Development in Clinical Trials
In this episode, Senior Director of Business Development Karen Harris joins Melody Keel to share how her two decades in clinical research—and her personal connection to rare disease—have shaped a career rooted in...
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Navigating Uncertainty: Leading Clinical Teams in a Shifting Research Landscape
With recent cutbacks at both the FDA and NIH, the clinical research industry is entering a period of deeper uncertainty. Budgets are tightening, timelines feel even more fragile, and the pressure on operations teams has never been...
Behind the Metrics: Leading Patient-Centered Clinical Trials
What if metrics could do more than track performance—what if they could transform the patient experience? In this episode, Andrea Bredin, a seasoned clinical project manager with over a decade of experi...
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The Talent Equation: Building High-Impact Clinical Teams
In the world of biotech and clinical trials, hiring the right talent is as critical as science itself. A single hiring decision can influence the success of a trial, the efficiency of an organization, and ultimately, patient outcomes.In ...
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Breaking Barriers in Clinical Research: Building Connections for Impact
In this episode, we sit down with Elizabeth Tabor, clinical research leader and industry super connector, to discuss:• The biggest misconceptions about clinical trials an...
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Leadership, Mental Health & Innovation in Clinical Research
In this episode, we sit down with Jess Thompson, MS, MBA, PMP, a leader in clinical research project management, to explore the evolving landscape of leadership, mental health, a...
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Transforming Clinical Operations: A People-First Revolution
In this episode of “Beyond the Protocol”, we sit down with Jeremy Mitchell, MBA, COO at The Research Associate Group, Inc. Jeremy to discuss the unique perspective we hold on transforming how organizations suppo...
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