Beyond The Protocol

Melody Keel

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.

  1. Where Does Trust Begin in a Clinical Trial?

    10/17/2025

    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 ongoing training, operational cracks erode not only team confidence but also trial credibility. In this episode, Melody Keel sits down with Cornelia Baumgartner, founder of Cetacea Clinical, to explore how mentorship, professional development, and team culture shape trust across rare disease, early-phase, and lean biotech environments. With over two decades of experience, from study nurse to strategist, Cornelia shares how clinical ops leaders can build resilient teams, embed trust at every layer, and position trials for success. What you’ll learn: • Why trust starts with leaders who mentor, train, and invest in their teams • How ongoing professional development strengthens trial quality and culture • The risks of misaligned outsourcing and the need for empowered internal teams • The connection between mentorship, operational readiness, and regulatory trust • Practical steps for sponsors to embed credibility without unnecessary complexity 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    31 min
  2. How Do You Turn Training into a Leadership Pipeline?

    10/10/2025

    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 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 success leading scalable development programs and integrating AI-powered learning across operations, Celeste shares how smart L&D strategy drives real business impact. In this episode, you’ll learn: How competency-based training can drive measurable promotion and performance outcomesWhat it takes to scale leadership development in GMP-regulated, cross-functional environmentsHow immersive tech (AI/VR) is transforming onboarding and clinical readinessWhy tying learning to culture, feedback loops, and operational systems is key to long-term successIf you're navigating high turnover, readiness gaps, or building internal talent pipelines, this conversation delivers the blueprint clinical ops leaders have been looking for. 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    41 min
  3. When Leadership Looks Like Us

    10/03/2025

    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 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 lever for retention, execution, and trust across trial ecosystems. Why lack of representation drives burnout, turnover, and underperformanceHow BWICR and Noir Research Collective are shifting the clinical leadership pipelineThe link between visibility, mentorship, and promotability in trial teamsWhy inclusive infrastructure is essential for long-term retention and qualityWhat clinical ops leaders must unlearn to create equitable, high-performing teamsThis episode is for everyone who believes that building diverse, inclusive leadership isn’t just the right thing, it’s what makes clinical research work better for all of us. 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    23 min
  4. Redefining Access

    09/26/2025

    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 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 rural and underrepresented communities remain overlooked in clinical trial strategies 👉 How digital-first outreach can drive equity, if it's built with clarity, culture, and care 👉 What most clinical teams get wrong about recruitment messaging and patient trust 👉 How cross-functional alignment (Ops, Comms, Vendors) can close access gaps 👉 What it takes to lead with empathy and make recruitment truly inclusive This episode challenges traditional mindsets and offers real-world insights for clinical leaders ready to rethink how trials reach and respect patients. 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    38 min
  5. When a Trial Saves Your Family

    09/19/2025

    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 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 strategy, to explore why inclusion must be built into the core of clinical research, not added on as an afterthought. What you’ll learn: 👉Why equitable trial design is essential, not optional, for real-world outcomes 👉How Denise operationalized DEI through data, dashboards, and site strategy 👉The emotional and systemic stakes of exclusion in research 👉How post-approval patient stories can uncover overlooked gaps in trial design Whether you’re running a single trial or shaping global research, this episode shines a light on why equity isn’t optional, it’s essential for impact that truly lasts. Make sure to subscribe on your favorite platform 🤍 And leave us a review ☺️ #ClinicalTrials  #DiversityInResearch #ClinicalOperations #InclusionMatters  #BeyondTheProtocol 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    35 min
  6. De-Risking Clinical Trials: What High-Performing Teams Get Right

    09/12/2025

    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 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 it really takes to manage high-stakes studies and guide clinical teams through complexity. In this episode, we unpack the people-driven strategies that accelerate timelines, reduce turnover, and rebuild trust across clinical teams: 👉 Why even well-designed protocols stall due to cultural and coordination breakdowns 👉 How early vendor decisions and internal misalignment quietly derail execution 👉 The true cost of underdeveloped leadership and how to close the gap 👉 Practical tools to reduce firefighting, boost retention, and strengthen morale 👉 How clinical operations leaders can build trial ecosystems that scale without chaos Whether you're overseeing one study or a global portfolio, this conversation reveals what’s often overlooked, and what’s essential for sustainable clinical trial execution. Make sure to subscribe on your favorite platform !! 🤍 And Leave us a review.☺️ This Show is brought to you by The Research Associate Group, Inc. 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    37 min
  7. AI Is Here …Now What? Evolving Teams & Training in Clinical Research

    09/05/2025

    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 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 traditional training approaches are failing in a tech-first environment  • What adaptive, ongoing professional development looks like in 2025  • How to lead teams through uncertainty, fear, and skill gaps  • Why culture, clarity, and curiosity matter more than ever  This episode offers real-world insight for clinical leaders balancing technological disruption with the human need for growth, stability, and purpose.  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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    16 min

  8. 05/09/2025

    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 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 the themes that resonated most and the cultural shifts reshaping clinical operations from the inside out. This isn’t just a recap—it’s a pulse check on the state of our industry, and a preview of where clinical operations must go next.  If you're leading teams, evaluating technology, building partnerships, or just trying to stay grounded amid the chaos—this is the episode you’ve been waiting for. Stay tuned—Season 2 of Beyond the Protocol is coming soon, with new voices, fresh perspectives, and deeper dives into the issues shaping the future of clinical research. Announcement coming soon. 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. This isn't about perfect processes—it's about real people sharing real solutions. Let's go beyond the protocol. That's all for today's episode of Beyond the Protocol—where we explore what it truly takes to deliver successful clinical trials.  If you found value in today's conversation, please subscribe, share with your network, and leave a review.  Have experiences or insights to share? Reach out and be part of the conversation. Join us next week as we continue to discover what lies beyond the protocol. You can catch it on : 📺 LinkedIn Live 📺 YouTube ▶️https://www.youtube.com/@BeyondTheProtocol 🎧 Spotify ▶️https://open.spotify.com/show/5tJlyePbEkmXLEPzSPtBcK?si=d209a257a8224056 🎧 Apple Podcasts ▶️https://podcasts.apple.com/us/podcast/beyond-the-protocol/id1798238612 🎧 Deezer ▶️https://dzr.page.link/Wy8E6rSXR7NpR15W7 🎧 Podcast address ▶️https://beyondtheprotocol.buzzsprout.com/ This Podcast is Sponsored by The Research Associate Group, Inc.

    37 min
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About

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.

Information

  • Creator
    Melody Keel
  • Years Active
    2K
  • Episodes
    18
  • Rating
    Clean
  • Copyright
    © 2025 Beyond The Protocol
  • Show Website
    Beyond The Protocol