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.

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.

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.

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-functional alignment.

What you’ll learn:

• Why trial delays often trace back to unclear roles—not missing features
• How to spot the early warning signs of tech friction in your ops team
• A practical framework to embed enablement into every stage of study delivery
• What VPs and Directors need to know before their next platform rollout

This episode is a must-listen for clinical operations leaders who are tired of firefighting and ready to align their teams for faster, cleaner execution—with or without a tech upgrade.

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.

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 grounded in the “why” behind the work, this conversation is a must-listen for anyone working at the intersection of people, process, and patient impact.

What You’ll Learn:

• How business development can be a clinical trial success driver—not just a sales function
• Strategies for navigating complexity and alignment in modern trial ecosystems
• Why personal connection can fuel leadership and deepen partnerships
• Ways to lead with empathy while meeting demanding sponsor expectations
• Advice for new leaders building careers in clinical research
  
  

Whether you're building sponsor relationships, leading through complexity, or searching for deeper meaning in your work—this episode offers real-world insights and human-centered strategies to lead with clarity, empathy, and purpose when it matters most.

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.

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 operations strategist Melody Keel addresses how leaders can steady the ship amid change.

She unpacks how to lead with clarity, empathy, and strategy during times of flux, and how to help clinical teams stay anchored in purpose while adapting to what's next.

What You’ll Learn:

✅ How the current federal cutbacks may affect clinical trials
✅ The emotional toll of uncertainty on trial teams—and how to manage it
✅ What adaptive leadership looks like in real-time
✅ How to stay mission-driven in resource-constrained environments
✅ Ways to reinforce team morale, stability, and quality under pressure

Whether you're facing budget cuts, team fatigue, or shifting timelines, this episode offers practical tools to lead with steadiness, empathy, and direction—especially when your team needs it most.

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.

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 building clinical trials that are both efficient and human-centered.

What you’ll learn:

• How patient-focused design leads to better retention and data quality
• Which metrics truly drive meaningful improvements in trial operations
• Ways to align cross-functional teams around shared patient-first values
• Why great clinical leadership starts with listening—to data and people

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.

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 building high-performing teams for some of the industry’s most innovative companies, Bryan shares strategies for optimizing recruitment in a competitive market.

We’ll discuss:

• The role of AI and data-driven hiring in accelerating clinical trials
• Why cultural alignment is a key predictor of long-term success in clinical operations
• The growing demand for specialized talent and the skills shaping the future of biotech
• How hybrid and remote work models are reshaping workforce strategies

Whether you’re leading clinical operations, managing a growing team, or looking to refine your hiring approach, this episode provides actionable insights to help you build stronger, more effective teams in an increasingly complex industry.

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.