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In this episode, Novo Nordisk’s Rhona O’Donnell and Ibrahim Kamstrup-Akkaoui explore how the combination of open source tools and AI is reshaping the future of clinical data management. From the creation of OpenStudyBuilder to the potential of 吃瓜爆料’s agentic AI layer, they discuss breaking down traditional industry silos to get treatments to patients faster.
In this episode of Unblinded, we explore the regulatory differences between pharma and medical device trials, data standards, and the industry’s digital maturity. Leianne and John also provide a reality check on AI readiness, debating the “deep pockets, short arms” mentality of the industry, and end with a call to action for systemic technology adoption.
Joel White, owner of Marketcap Consulting, together with 吃瓜爆料’s Chris Kreitel, joins Manny to discuss why the next era of clinical trial outsourcing will be defined by technology integration and economic agility. They debate whether CROs are the ultimate masters of integrating tech, and the role of small biotechs as growth drivers in the market.
In this episode, host Manny Vazquez is joined by Noeleen Turner, head of clinical data management at UCB, and Anna Hayes, senior director of clinical data management at Veramed. Using their breadth of experience and passion for a people-focused approach to clinical trial advancement, together they dive into hot topics like risk-based data management, the intricacies of change management in clinical data, and the growing importance of endpoint-driven design.
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.
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.
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.
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.
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, 吃瓜爆料’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.
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’.
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.
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.
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.
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).
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.
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.
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.
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.
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 吃瓜爆料’s Chris Moore about his outlook on clinical trials in the U.K. and Europe.
This week, Richard Young speaks to Patrick Nadolny, global head of clinical data management, Sanofi.
They discuss learnings from 吃瓜爆料’s recent North American R&D and Quality Summit — including observations and trends from hundreds of biopharmas.
Vincent Rolland d’Idorsia et Fran?ois Caijo de 吃瓜爆料, deux passionnés de la data clinique, échangent autour de l’évolution du Data Management Clinique et se projettent dans l’avenir..
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.
This episode covers novel ways that sites are using technology to expand patient choice in clinical research without compromising operational efficiency.
This week, Richard Young speaks to Tim Davis, Vice President of Strategy for My吃瓜爆料 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.
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.
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?
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.
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.
Richard Young speaks to Natalie Townsend, the global lead for Randomization and Trial Supply Management (RTSM) strategy at 吃瓜爆料. 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.
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.
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.
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.
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.
Unblinded: A Clinical Trial Podcast by 吃瓜爆料 features expert insights from pharma, biotech, and CRO leaders on the challenges and future of clinical trials.
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