Season 2 Introduction

We're back with The ConcertAI Podcast for Season Two!

In our first episodes, we delve deep into RWE's role in regulatory applications, such as designing registrational clinical trials and developing robust data sets that shape trial designs and submissions. We're exploring the evolving landscape of efficacy, safety, and the use of external control arms, especially in light of recent FDA guidance.
But that's not all. Season Two also highlights incredible progress in clinical trial networks and technologies, especially those facilitating trials in community settings. We're excited to feature Exigent, a key partner in the development of ConcertAI's Digital Trial Solutions.

Moreover, we're expanding our focus on multimodal data. From discussing its significance and new analytic approaches like AI and causal inference, to exploring real-world applications in study design and analyses. Expect deep dives into patient responses, patterns of resistance to treatments, and how these insights are revolutionizing study designs.

Join us for insightful discussions, expert interviews, and a journey into the future of healthcare and clinical research. Listen to The ConcertAI Podcast on Apple Podcasts or Spotify, and immerse yourself in the latest innovations in healthcare technology.

Website
www.ConcertAI.com

LinkedIn
www.linkedin.com/company/concertai/

Twitter
www.twitter.com/concertai

Transcript

Hello and welcome back to the ConcertAI Podcast, Season Two. We're going to start off this season with a returning ConcertAI colleague, Jennifer Rider, and we're going to talk about the area of RWE with a particular emphasis on regulatory applications. This would be design of registrational clinical trials, developing underlying data sets that inform the trial design, producing data sets that accompany the trial submission itself that may be covering the current standard of care outcomes, both from an efficacy and safety, and external control arms. On the occasion of the FDA's guidance, this has actually become a much more important area.

In addition to that, there's been an incredible progress made in a variety of areas. Clinical trial networks have matured. Technologies that support doing clinical trials in the community have also advanced considerably. So we're going to spend quite a bit of time on that, both from the perspective of the technologies, what they're enabling, but also talking to some of the trial locations and trial networks themselves. And we're going to feature Exigent first, who we've worked with over the entire course of developing ConcertAI's digital trial solution.

In addition to that, we are now expanding the work in multimodal data, whereas we talked about the importance of multimodal and that it actually allowed application of new analytic approaches, AI and causal inference-based approaches, now use cases have accelerated, and we're really seeing the value that it can bring in a variety of different areas; study design, analyses to inform who's going to respond, non-respond, why they're non-responding, how patterns of resistance to current available treatments actually develop and how that should be accommodated in a variety of different analyses and study designs.

While we will, in fact do more than that, I wanted to give that overview just to give you the flavor and the context of what we're doing as we go into this year.
Thank you again for taking the time to listen to the podcast. Wherever you are, good morning, good afternoon, and good night.