Unblinded: A Clinical Trial Podcast

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 Veeva’s agentic AI layer, they discuss breaking down traditional industry silos to get treatments to patients faster.

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