A People-Focused Approach to a Risk-Based Future in Clinical Trials

ICH E6(R3): Shifting the Paradigm from Process to Purpose

In this episode, we pull back the curtain on the monumental effort required to reshape global clinical trial standards. Manny and guests Lisbeth Bregnhoj and Cheryl Grandinetti explore why ICH E6(R3) is the catalyst the industry has been waiting for.

The Unstuck Industry: A New Equitable Model for Pharma

Brian Johnson, former head of R&D technology at Takeda, now consultant, shares his unique perspective on a topic that’s top-of-mind for many: how do you introduce new technologies and processes without alienating the people who need them most? He and Manny also tackle the critical issue of health equity, examining how technology can help diversify clinical trials and, in turn, create a more equitable future for all. Join us as we explore the business case for change and the crucial steps needed to unstick the industry from its current trajectory.

Innovation from the Inside: How Sites Are Redefining Clinical Research

Manny is joined by co-host Denali Rose and MSKCC’s Joe Lengfellner, to discuss the shifting focus from a one-size-fits-all approach to redefine site centricity. They talk about how the role of a clinical trial coordinator is changing, the challenges of managing data and protocol amendments across different systems, and the promise of technologies like EHR-to-EDC to streamline workflows.

Patient vs. Process: Bridging the Gap for a Better Trial Experience

Join host Manny Vazquez as he sits down with Joyce Moore, leading voice in patient recruitment with over 25 years of experience in the industry, most recently at Allucent. In a field often focused on the logistics of data collection and study processes, Joyce offers a crucial perspective: seeing patients not as subjects, but as collaborators. She and Manny discuss the delicate balance of collecting essential data for clinical endpoints without overwhelming patients.

Recorded at R&D and Quality Summit 2025 in Madrid.

Biggest Risks (and Possible Rewards) of AI in Clinical Data

Are we any closer to working out the human-machine relationship needed to embed AI in clinical development? To discuss this and all things automation, Veeva’s Chief Technology Officer Drew Garty joins host Manny Vazquez as he kicks off the new season with two innovators in the industry: Doug Bain, founder and consulting partner at Clinflo, and Robert Bergann, clinical digital innovation leader at Bayer.

Is a Heavy Tech Burden the Price of Progress for Sites?

Richard Young passes the torch to Manny Vazquez, our new podcast host, and shares his reflections before turning off his mic for the final time. Later, Manny is joined by renowned industry thinker and site leader Brad Hightower, owner of clinical research center Hightower Clinical in Oklahoma. They discuss whether the growing tech burden is the price of progress for sites, plus tips on how sponsors can make sites’ lives easier. Brad also explains a few implications of the recent FDA draft guidance on DCTs and the upcoming site conference he helped to set up, ‘Save our Sites’.

AI and Clinical Transformation: High-Value or Hype?

Novo Nordisk’s Vice President for Clinical Data Operations and Insights Ibrahim Kamstrup-Akkaoui joins Richard this week’s episode. As Ibrahim explains, the pace of innovation in clinical development is accelerating, sometimes generating billions of relevant data points for study teams to manage. AI is already adding value and can help organizations sustainably manage this growth. They discuss how to start small and think big with AI and concrete examples of where it is delivering for Novo Nordisk, such as generating meaningful test data and study builds.

Does Data Science Require Data Perfection?

Pfizer’s Vice President for Data Monitoring and Management Demetris Zambas joins Richard to discuss the evolution of data science, the potential applications of AI, and whether we still need to strive for data perfection. Although the tools have changed, the mission and successful traits of a strong data scientist remain consistent — and could soon be enhanced by an AI assistant.

The Launch of Boehringer Ingelheim’s One Medicine Platform

Nicole Raleigh hosts this special episode on-site from Boehringer Ingelheim’s Human Pharmacology Center in Biberach, Germany. Andrea Kloeble and Daniel Schwenk are part of the team reimagining drug development at Boehringer Ingelheim through the One Medicine Platform. And Richard is in the guest seat this week to put this transformative initiative into industry context: as he explains, life sciences is no longer willing to accept single-use data.

Against All Odds: Finding a Treatment for SPG50

In a deeply personal and moving episode, two patient advocates share their stories of working tirelessly to deliver safe and effective gene therapy for children suffering from spastic paraplegia 50 (SPG50).

Are We Too Risk Averse in Clinical Research?

This week, Richard Young speaks to Ken Getz, executive director and research professor at Tufts Center for the Study of Drug Development. In this episode, Richard and Ken debate whether clinical research is striking the right balance in its approach to risk and innovation, the problem-solving role played by sites, and CISCRP’s work to improve public trust in scientific advances.

Putting Patient Data at the Heart of Your Strategy

In this episode, Richard Young speaks with Terttu Haring and Leonie Christianson from Syneos Health. Nowadays, clinical data managers have the tools to collect insights from large volumes of data. But has this influx of data and tech caused us to move farther away from the patients we serve? This episode outlines the major opportunities for life sciences organizations to put patients back at the heart of clinical strategy.

Sites Are Voicing Their Concerns, But Are We Listening?

In this week’s episode, Richard Young speaks to Vivienne van de Walle, medical director and founder of PT&R (an independent research site in the Netherlands), and Bree Burks. In this episode, Vivienne and Bree explain the tangible ways that sites (and patients) are hurt by inconsistent technology and the steps to make it better.

Transforming Clinical Operations: What Comes Next?

In this episode, Richard Young speaks with Bayer’s Head of Clinical Trial Management Services and Solutions, Emma Earl. Together they outline the major opportunities and the missing ingredients for delivering efficient and patient-centric clinical trials.

The State of Clinical Trials in the U.K. and Europe

We have a special episode for you this week! In a twist to our usual format, Nicole Raleigh of Pharmaphorum is in the host seat interviewing Veeva’s Chris Moore about his outlook on clinical trials in the U.K. and Europe.

Clinical Data Innovation In A Non-EDC Centric World

This week, Richard Young speaks to Patrick Nadolny, global head of clinical data management, Sanofi.

Takeaways from Veeva’s R&D and Quality North America Summit

They discuss learnings from Veeva’s recent North American R&D and Quality Summit — including observations and trends from hundreds of biopharmas.

Evolution du Data Management Clinique

Vincent Rolland d’Idorsia et François Caijo de Veeva, deux passionnés de la data clinique, échangent autour de l’évolution du Data Management Clinique et se projettent dans l’avenir..

Debunking the Myths of AI

Does ChatGPT understand data from clinical trials? Andy Cooper, CEO of Cluepoints, explains why industry context will be critical for the success of AI and machine learning initiatives in clinical data.

Does Patient Choice Equal Site Headaches?

This episode covers novel ways that sites are using technology to expand patient choice in clinical research without compromising operational efficiency.

Why We Need to Expand Patient Choice in Clinical Trials

This week, Richard Young speaks to Tim Davis, Vice President of Strategy for MyVeeva for Patients. In recent years, decentralized clinical trials, patient centricity, and site centricity have become buzzwords for sponsors and CROs. But positive change starts with expanding patient choice during clinical trials.

How Can We Prepare for the Future of Clinical Trials?

This week, Richard Young is joined by Rhona O’Donnell, VP, Data Management Systems and Standards at Novo Nordisk. They discuss the evolution of the data management role, and how we can prepare for the future through collaboration and more effective training for the next generation.

Are We Any Closer to Patient-Centric Trials?

This week, Richard Young speaks to Alan Morgan, CEO Advisor of Excelya. In recent years, sponsors and CROs have invested heavily in “big data” tools for site selection and productivity. But has that investment paid off?

Is Data Management the Glue of Modern Clinical Trials?

Listen to how data managers can prepare for the future of clinical trials by adopting new technologies and skills that will keep decentralized clinical teams connected.

Data Managers: Driving the Future of Clinical Research

In this week’s conversation, hear how clinical data professionals’ roles are evolving in a world of decentralized data. It’s a great time to be a clinical data professional, they agree, as a once invisible role moves front and center to optimize trial protocols, operations, and results and speed patient access to better treatments.

How Will RTSM Impact Clinical Data?

Richard Young speaks to Natalie Townsend, the global lead for Randomization and Trial Supply Management (RTSM) strategy at Veeva. They discuss the evolution of ‘digital’ clinical trials from the early days of phone-based and spreadsheet-centered activities to the role technology is playing today.

How Clean is Your Data?

Richard Young speaks to Trevor Griffiths, senior director for clinical data management at Syneos Health. Data management is becoming much more complex for CROs, as trials become larger and data sources more diverse.

Will Traditional EDC Exist 10 Years From Now?

Richard Young speaks to Doug Bain, chief technology officer at KCR, a contract research organization (CRO). They discuss the role of electronic data capture (EDC) in today’s complex, dynamic clinical trial landscape.

What Should Be in Your Digital Trial Toolkit?

Richard Young speaks to Tanya du Plessis, chief data strategist and solutions officer at Bioforum the Data Masters, a data-focused CRO. The old days of linear trial processes and pushing paper are thankfully over, presenting exciting opportunities in clinical data management.

Life Sciences in Europe: Breaking Down the Barriers

After more than two years apart, European life sciences came together in Zurich in June. There are big advances underway that will make clinical research faster, better connected, and more patient-centric. But there’s also frustration at the silo-driven approach.