Beyond the Protocol: The Why, The Vision & What’s Ahead

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 – A sneak peek at upcoming guests, topics, and why this podcast is for YOU

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.

The Research Associate group
Architecting Clinical Success | One Blueprint at a Time Pharmaceutical Manufacturing

Disclaimer: This post contains affiliate links. If you make a purchase, I may receive a commission at no extra cost to you.

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.

Chapters

• 0:00 Welcome to Beyond the Protocol
• 1:44 Melody’s Career Journey
• 3:14 Finding Purpose in Clinical Operations
• 4:29 Lessons from Consulting
• 5:44 The Real Focus: People, Culture, Process
• 6:44 Why This Podcast?
• 8:14 What’s Ahead for the Industry
• 9:44 Guest Teasers & Format
• 11:54 A Call for Innovation & Community
• 12:59 Show Details & Final Invite

Transcript

Melody Keel: 
 
So welcome to Beyond the Protocol, the first episode of this series that I'm so excited to bring to you. I needed a platform. I wanted a way to continue the conversations that I've been having with incredible people from this industry that I feel chose me. And so here we are. I'm planning to bring some great guests and share all our insights about clinical operations and the day-to-day and the real nitty gritty of how we get the work done and how we can do it better, and what the future of our industry looks like for us, and most importantly, for the patients that we serve.

And so let me tell you a little bit about myself. Welcome to Beyond the Protocol. I am Melody Keel and I've been in the industry for over 20 years now, which I shudder just a little bit when I say that 'cause I feel like it ages me, but I fell in just like most of us do. I came outta grad school, planned to go into a teaching program in Raleigh, North Carolina.

And I come from a family of teachers and preachers and I just thought that was the path that I was going to take, but. Plans were different for me, and that funding fell through. And I was a recently graduated student with not a lot of funds and an apartment lease that I was committed to. And so I scrambled to find work and I applied to INC research every day for about 36 days.

I faxed my resume to them every day. Finally I got a call from this wonderful HR lady and she said we want you to come in and interview. We finally have a opening and we are sick of getting your resume on our fax machine every day, and the rest is history. I like to tell people that I am a failed pre-med student.

I didn't focus on academic studies as well as I should have my first semester of undergrad. And so this industry gives me the joy of being in medicine. In a different way and merging science, which I love, and having an impact on patients and being able to work with doctors and nurses and people that have a mission that's similar to mine and this industry has provided that for me.

And so I haven't looked back. I took the CTA role and learned as much as I could and got the opportunity to move into a CRA role, and it was at that hate space in my career that a mentor. Shared with me that she felt I should become a consultant and that I had great problem solving skills and the ability to work with all kinds of people.

And she felt like I shouldn't just limit myself to one employer, which honestly was one of the best things that could have happened to me because it gave me the opportunity to work in different organizations and see how they work, how they, big organizations, small startups, everything in between. How their processes work how they support their people, train their people, hire their people and what seems to make companies successful in terms of running trials from a clinical operations perspective versus those that are chaotic and stumbling and fumbling and oftentimes fold, especially when they're new because they didn't understand the importance of clinical operations and the people behind them.

And here I am. The last six or seven years I've been in leadership director level roles, and I had the wonderful opportunity of supporting teams and helping them deliver trials. I. And with that viewpoint, I've had the chance to engage with individuals who are rock stars and they know what they're doing and they're very successful.

And then I've had the opportunity to work with people who are wonderful and they can be successful and be those rock stars, but they just didn't have enough support or development or training or even the culture from leadership to give them what they needed to be successful in the role. And so here I am.

The research associate group is a company that I started years ago that allowed me to do my consulting with companies, and now I've decided it's time to make the pivot and begin to be able to offer what I do. In a larger capacity so that more people can gain the benefit of feeling supported and having a strategy to be successful in clinical operations.

And so my focus is people, culture and processes. That's what I'm all about. And I think for the people that know me have worked with me, they can vouch for me and say, it's about service for me. How can I help you? How can I make you better? How can we win together? And that's where we are. And I'm launching this podcast or this show because I wanna continue to have these conversations.

I wanna make our industry do better. And I think we get really caught up in the idea of it's all, it's always been what we've done. Even though it might not work. It never work, or it's not working anymore. We just keep doing it. 'cause that's what we know. This series gives me an opportunity to have conversations with the people that know it's time to move away from that practice and become innovative and outside of the box on how we can do better for the patients at the end of the journey, who get to benefit from these amazing therapies and drugs that we're developing.

What's going on in our industry? I think that's a conversation that is being had. Every day I talk to friends and colleagues and I see messages and posts on social media and everyone's kind of feeling, there's almost an uneasiness about where are we headed? And we know that in our industry it takes a while for things to change.

We know it needs to happen, but it could be another five years or 10 years before we really see the needle move. We begin to do things differently, which I think is fascinating. Knowing that we're a research-based industry and we have data that shows us what doesn't work and what does, but yet we continue to do the things that don't work amazing to me.

But here we are. We're gonna talk about it. We're gotta find the people who are just as passionate as I am about clinical operations, clinical research development. And what we can do individually and collectively to make this better. And so that's where we are. And the podcast aims to be something different.

I didn't wanna just have another show where you walk away and you feel like. That was entertaining. I think there's some amazing podcasts out there in our industry but a lot of times they don't really focus on clinical operations and the companies that are on this side of it, the sponsors, the biotechs, the CROs that are partnering with the sponsor companies to get the work done.

And so that's what this is about. That perspective of it and how we can collaborate and connect with vendors, Andys and people who push this train forward rather heavy and clunky train, but amazingly, we get the job done and that's what ClinOps is all about. I. So in upcoming episodes, we will have people from all walks of life that are connected to clinical operations, clinical research.

I have some wonderful people that I've worked with over the 20 years. I. I've been in this industry and I'm asking them all to come be part of this show because I think they have a perspective and insight and experiences and knowledge that can help us all take nuggets, take them back to where we are with our own professional careers and where we are in leadership and how we're training the next generation of clinical operations professionals.

All of that can come together in this space. And be a resource for us and a talking point, and help us to maybe open up the curtains behind the scenes of clinical operations and really talk about maybe some difficult topics that we just aren't comfortable talking about. This is the space for that, and I'm really, I.

Excited to do that. I think we all know there's a lot of challenges within clinical operations and research from a clinical trial perspective. And those changes aren't those issues aren't going away anytime soon. And so why not start tackling them as a community? Bring people from all different levels in, and so I have vice presidents of operations that I'm gonna bring into the fold for this show.

I have recruiters, wonderful recruiters, wonderful business development people from CROs, their perspective. I have CRAs who have been on the front lines and have been doing this. For years. Literally one of my colleague friends calls himself a CRA dinosaur. But just imagine what he's seen and how he's seen our industry evolve over the last 25, 30 years that he's been a monitor.

And he loves it. He chose to stay in monitoring. He doesn't wanna go into management. He likes being in the trenches and out in the field. I think those are the perspectives that we would like to hear from. Like, why did you choose to stay in monitoring and not come out and move into some of the other roles that get you off the road where you're not hopping a plane three or four times a week.

So that's what's planned, and those are the types of guests that we'll have on. In addition to some other founders and consultants, I think. We are moving to understanding that specialized expertise is so undervalued and there are incredible consultants and smaller companies that can have such an incredible impact for the organizations that are responsible and taking on delivering data to be able to get therapeutic drugs and therapies approved.

And why not have them come join us and give us their perspective and share what their subject matter expertise is and how they envision improving things in this landscape of clinical trials. I'm so excited. I just think it's endless what we can do in this space. And what's to come for our industry.

That's another side of it. We're moving at a fast pace and things are changing quickly. We have the introduction of ai. There's so many things that in five years we'll look back and we'll feel like this was a turning point for us. Similarly to when Covid happened, which was five years ago, right?

I can't believe that. But our industry changed drastically as a result of that world of Ben, and I think we're in the same space today. So this is a mark on the timeline and I think we should make the best of it and come together and collaborate and really set out to be innovative and think outside of the box and not just do things the same way that we always have.

So if you have thoughts or ideas or suggestions about the show or you would love to be a guest, I would love to have you reach out to me and join me. I think it would be fantastic. And also. We'll continue to have our show air every Friday at 10:00 AM Eastern and so come and give feedback and comments connect with me on LinkedIn to continue the conversation, and I look forward to you joining me on Beyond the Protocol every week to have continued discussions about clinical research operations and the trials that we're running and delivering and how we can do it better in a more successful way.