Why GCP E6(R3) Is a Turning Point for Clinical Research and Why FutureMeds Is Now a TransCelerate Certified GCP Training Provider
- FutureMeds
- 3 days ago
- 5 min read
By Melissa Kerr, UK Quality Manager
A personal journey from clunky training slides to human-first compliance, and how E6(R3) can finally empower, not encumber, the people across research.
Regulatory training once meant eight-hour marathons of unreadable slides and warm rooms. As the latest revision of Good Clinical Practice arrives, it offers a chance within FutureMeds to bring something rare in compliance: a genuine opportunity to lift the people who make research happen.
Compliance Is Changing, And It Should
In 2016, I sat through the GCP E6(R2) training as a budding Quality Manager. The experience was typical: one PowerPoint deck crammed edge to edge with tightly packed little black text, and a flat delivery that made eight hours feel eternal.
I squinted, scribbled, and promised myself one thing: if I ever had the chance to deliver GCP training, I’d do it differently. Because while that session was packed with value, and delivered with the generosity of a seasoned expert, it lacked something critical: engagement.
And that, to me, is what GCP E6(R3) offers a chance to restore. Engagement across the board.
Let’s Be Honest: GCP Rarely Sparks Joy
For most people, the words “GCP update” don’t exactly quicken the pulse. Regulations are often perceived as overly complicated, filled with jargon, and loaded with grey areas that often leave us pondering, overthinking, and unfocused.
But it doesn’t have to be this way.
In my opinion, E6(R3) isn’t just about regulatory compliance. It’s about people:
It’s about our participants who dedicate their time and commitment to our research.
Our teams, who dedicate their time, passion and energy in investigating and delivering better medicine for millions of people around the world.
Our shared goal to make better medicine while upholding the most ethical practices and protections.
It’s about every researcher, whether they’re designing a trial, monitoring it, or delivering it on the ground, having the confidence and tools to do the right thing, first time, without second-guessing ambiguous language or outdated processes.
Where R1 & R2 Lacked: Real Life Doesn’t Fit Neatly Into Protocols
I started my career at a clinical research site in 2008. And I’d like to think that means I understand the realities of what happens day to day, not just the textbook version. I don’t feel like I have a black-and-white mindset about compliance, I have experienced what it’s like in the grey, or rather sometimes colourful regulatory landscape, and I hold no judgement when it comes to the weird and wonderful.
I’ve had participants disappear into the depths of Guatemala or Goa to take advantage of the study destination to extend their gap year, using their stipends from stool samples and had the craziest reason for becoming lost to follow up.
I’ve been at the site juggling multiple protocol deviations that hit all at once, thanks to an ash cloud, and an earthquake, and they were the most unusual protocol deviation reasons.
My commitment to sites has seen me stand in the middle of a muddy football field at the tail end of a hurricane, supporting a DCT site in a trailer vehicle to be ready for an audit that was happening that day. I kind of think I’ve navigated some weird and wonderful real-world chaos with some very human compliance challenges.
Why am I mentioning these stories? Regulations matter. But practicality matters too.
And GCP E6(R3) finally reflects that. It gives us the confidence and clarity to weather those unexpected storms without drowning in red tape when we are trying to put things right when things haven’t gone according to plan.
Training That Respects Time and Intelligence
When I joined FutureMeds, the timing was perfect. Our network was expanding fast, and E6(R3) was landing with a message we truly believed in: fit-for-purpose, clear, and outcome-focused.
Joining the company also offered me an opportunity to make good on the promise I made almost 10 years ago. Determined not to inflict another 60-slide death-by-PowerPoint, I explored video formats. But it still wasn’t quite right.
So I tried to invoke the passion and energy of a training team I have been lucky to have worked with in the past. I’ve led a variety of incredible, inspiring teams, some of who, are Instructional Designers. I’ve listened to what doesn’t work. And I’ve learned one thing loud and clear. ‘If your training makes people groan… your message is already lost.’
“People’s time is precious because once its spent, you don’t get it back, and when someone invests their time in completing mandatory training, the least we can do is deliver something meaningful, with a lasting impact in return.”
Ahead of the deadline for R3 implementation, based on these lessons I learnt, at FutureMeds, we’ve created something better, modular, visual, interactive training with light gamification.
And now, FutureMeds is also a recognised TransCelerate GCP Training provider. Our training isn’t just “good enough.” It’s respected externally.
Decluttering the Internal Rulebook of Compliance
We didn’t stop at training. SOPs, too, needed an overhaul. Instead of bloated documents written like regulatory encyclopedias, often to impress, we asked: what do site teams actually need to succeed?
The answer?
Plain language
Clear guidance
Tools that help people get it right, first time
Because less confusion means fewer errors. -> And fewer errors mean better outcomes -> Better outcomes lead to better quality. Isn’t that the whole point?
“Procedures aren’t supposed to be written and read like a regulatory textbook. They should help people on the clinic floor get it right, the first time. Not dense. Not overwhelming. Not there just for the sake of it. Procedures should be crystal clear guidance.”
Culture Makes Compliance Stick
Even the best-designed systems fall flat without the right culture. So we launched something simple:
Bite-sized, visual newsletters with plain language and clear takeaways.
On top of this, we dug into our quality data, not to judge, but to spark conversations. To ask: What can we learn? What can we improve?
“Culture doesn’t change with policy/SOP updates or new training. It changes when people talk about what matters transparently, often, and without fear.”
R3 Is More Than a Revision. It’s an Invitation.
From my early days struggling through regulatory slides to helping lead a global site network through the R3 transition, one truth remains: people make progress and research possible.
When we simplify compliance, when we make it meaningful, we raise the standard.
To me, the journey from R2 to R3 is like building a bridge. From complexity to clarity. From tick box exercises to collaboration. From fear of non-compliance to confidence in purpose.
R3 is an invitation to evolve. To create a culture of empowered researchers, participant-first thinking, and meaningful quality. So GCP isn’t just compliance. It’s compassion. It’s clarity.
It invites us to evolve from checking boxes to building trust. From training rooms to empowered teams. From regulations to real, human-first research.
And that’s a future worth showing up for.
About Melissa Kerr
Mel brings over 17 years of experience in clinical research, with a strong track record of compliance oversight, strategic leadership and innovation for operational excellence. A recipient of the CEO VIP Gold Award at Synexus for improvement initiatives in the UK that became global standards. Mel has led high-performing global departments to support study operations and global expansion and served on the HRAs Research Ethics Committee during and beyond the pandemic. At FutureMeds, Mel champions quality for the UK and continuous improvement to support FutureMeds' growth as a leading and trusted research partner.
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