In this episode of Unblinded, host Manny Vazquez is joined by Leianne Ebert, Head of Data Operations at Alcon, and co-host John Acampado, Senior Director of Clinical Strategy for Veeva MedTech. Together, they 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 Veeva’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.

From the intense complexity of dialing in language across regional borders to the latest push for a truly risk-based approach to clinical trials, the discussion highlights:

• A shift in strategy: Why the industry is finally moving away from "one-size-fits-all" in favor of flexibility and high-level data governance
• Defining quality: Breaking down what Critical-to-Quality (CtQ) factors actually look like in practice and how to align that understanding between sponsors, service providers, and investigators
• The future of inspections: It’s not just a change for sponsors – regulators are also facing a major shift in how they harmonize inspection techniques in a risk-based world

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.

They debate the potential of LLMs to revolutionize patient recruitment and widen access to clinical trials, addressing the critical issue of reaching more diverse patient populations.

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. Joyce also highlights the critical role of technology in enhancing the patient experience and the importance of keeping participants informed about their progress and the purpose behind the data being collected.

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, 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.

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