Beyond The Protocol

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 ongoing training, operational cracks erode not only team confidence but also trial credibility. In this episode, Melody Keel sits down with Cornelia Baumgartner , founder...

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 2025 Top 10 OnCon Learning & Development Professional, to explore how pharma and clinical organizations can transform training into a powerful leadership pipeline.  Drawing from her...

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 Clinical Research (BWICR) . we go into the operational impact of building leadership that reflects the communities trials serve. We explore how representation isn’t just a DEI initiative, it’s a business-critical...

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 Alyssa Beck , Account Management Lead at 1nHealth and former Creative Strategist, we explore what access truly means in 2025 and why patient recruitment must evolve beyond convenience and assumptions....

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 deeply personal when her father achieved remission thanks to a therapy approved through a clinical trial. In this episode, Melody Keel sits down with Denise , founder of Empactful Ventures, LLC and a leader at the intersection of science, equity, and st...

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 Suzanne Vyvoda , Founder and CEO of Concordia BioStrategies and a seasoned Clinical Operations Strategist. With a track record of leading trials across 40+ countries and 500+ sites, Suzanne shares what i...

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 operations leaders can keep pace with AI-driven innovation while investing in the people who make trials happen  • How AI is transforming trial design, data analysis, and patient engagement  • Why...

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 delivered.  Across every conversation, one message was clear: progress in clinical trials doesn’t come from process alone, it comes from people. In this episode, we reflect on...

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 demands In this episode, Melody Keel sits down with Jason Spivey , Founder of Unifora and clinical tech strategist, to unpack how even the best technology can cause clinical operations to break down without the right leadership, workflows, and cross-function...

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 empathy, strategy, and purpose. Karen breaks down what it means to lead with intention in the high-stakes world of clinical trials. From navigating complex sponsor partnerships to staying...

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 higher. But while the environment may feel unpredictable, our commitment to patients—and the teams who serve them—remains steady. In this solo episode, Clinical operati...

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 experience, shares how she blends data-driven decision-making with deep empathy for trial participants.  From reducing burden to leading cross-functional teams, Andrea offers a fresh perspective on buil...

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 this episode, we sit down with Bryan Blair , a leader in biotech and pharma recruitment, to explore the evolving landscape of clinical hiring.  With a background...

In this episode, we sit down with Elizabeth Tabor , clinical research leader and industry super connector, to discuss: • The biggest misconceptions about clinical trials and how to address them • Why diversity in clinical research is more than a buzzword—and how to drive real change • The role of networking in accelerating careers and innovation in the field • Practical strategies for leadership a...

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, and professional development in the industry.  Jess shares insights on: •𝗟𝗲𝗮𝗱𝗶𝗻𝗴 𝗶𝗻 𝗮 𝗛𝗶𝗴𝗵-𝗦𝘁𝗮𝗸𝗲𝘀 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆: How clinical research professionals can develop strong leadership skills while managing complex projects. •𝗠𝗲𝗻𝘁𝗮𝗹...

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 support and develop their clinical operations teams. Key Takeaways: The Human Side of Clinical Trials – Why putting people first transforms operational success Leadership Development Crisis –...

Welcome to the very first episode of Beyond the Protocol ! In this solo pilot, Melody Keel shares the vision behind the podcast, the industry challenges we’ll tackle, and what listeners can expect in the episodes ahead. Key Takeaways: Why This Podcast? – The inspiration behind Beyond the Protocol Clinical Operations Today – The biggest challenges and opportunities in the industry What to Expect –...

Welcome to Beyond the Protocol —where authentic conversations about clinical research happen. Hosted by Melody Keel , bringing together diverse professionals from across the industry to share insights and experiences about what it really takes to deliver successful clinical trials. From operational challenges to industry innovations, we dive deep into the real discussions that matter to clinical r...