Beaconcure Podcast: Clinical Trial Innovation – Spotlight on Quality, Review, and Collaboration

In this video podcast, Névine Zariffa, leading voice in biometrics and data science, and Beaconcure Co-Founder and COO Ilan Carmeli, discuss the future of technology in improving clinical trial efficiency and quality during statistical analysis review. Névine and Ilan discuss some of the challenges reviewers currently face using traditional review processes, and Ilan demonstrates new Verify features that streamline delivery review processes and enhance transparency, traceability, and predictability. The conversation concludes with a glimpse into near-future Verify feature releases to automate statistical output generation, manage resources, and enhance GenAI capabilities.

This transcript has been edited for clarity.

Névine Zariffa: Hi, and a warm welcome to all of you. My name is Névine Zariffa, and today on my first ever podcast, we will be discussing the future of clinical trials, and how technology can really, truly make them faster and better. 

With over 25 years in Pharma, hundreds of people on my teams, hundreds of clinical trials, I can tell you that we often heard from technology experts: “Hey – I know how to make your world better.” That wasn’t always the case when we looked under the hood. However, my guest today, Ilan Carmeli, of a company called Beaconcure, will show us that actually the future is here.

They’ve done the hard work of building something that is concrete that brings value. And I’m delighted to have you with us, Ilan. Could you please say a few things about yourself, and your company and your product, and then we’ll get into the conversation.

Ilan Carmeli: Sure. First of all, thank you for having me. My name is Ilan Carmeli, I’m the COO and Co-Founder of Beaconcure. That means that I’m in charge of the fun stuff – execution, product, and R&D within Beaconcure. Today we are going to talk about Verify’s new modules and roadmap, and I’m pretty sure it’s going to be a very interesting discussion about these topics.

Névine Zariffa: Okay, so let’s back up just a second and explain why we care about clinical trials. Clinical trials are the way we generate evidence, data, and statistical results that tell us – does the drug work in improving the clinical outcomes for patients with a particular disease? And what safety issues can we expect, and how would we deal with them? 

What’s important about that is, if that’s the way we find out if we’re going to get a new medicine out to a patient, we want to do this work well, and we want to do it quickly, so that we get to them the medicines that really matter for their disease. Tell us more about how you got to care about statistical analysis.

Ilan Carmeli: You can imagine today, a very smart person actually needs to validate the titles, the footnotes, the formats, the standards, and so forth, instead of focusing on making sure that efficacy or the safety of the study is according to the company guidelines. Our first module, validation, actually helps this person to get rid of their administrative tasks, using technology. 

During our discussion today, we are going to talk about the second module for the draft review process, to help you to communicate, collaborate, and to manage your statistical analysis review end-to-end in an efficient way. Again, using technology – having everything in one place under a digital framework, vs. today, which is based heavily on Excel, Word documents and emails –  elements that were not created for such complex processes.

Névine Zariffa: So we’ve got smart technical people – statisticians, programmers, there are clinicians on these teams or regulators, there are clinical operations, there’s project management, there’s safety experts, etc. They need a one-stop-shop where they can look at all of the draft outputs and talk with each other in real time about what they’re seeing, what concerns they have, any changes they want made, so that at the end of the day, this clinical trial is reported accurately, and we know what the drug does or doesn’t do for patients.

And today you’re saying that it’s a very manual process. We’re not using these experts’ time in a smart way, and that’s not good,  ultimately, for patients. Right?

Ilan Carmeli: Exactly.

Névine Zariffa: Tell me more about how you bring all these – we used to call them cross-functional experts: they’re on a clinical trial, they’re in the team. How is it that they can get value out of your product in that cross-functional space?

Ilan Carmeli: Let’s start from a high level, and then we have a deeper dive into the product. Our product goals are based on 3 items. One is transparency. Making sure, for example, that you can get an answer to a simple question: What is the real status of my delivery? The next is predictability. I would like to predict when the outputs and when the delivery is going out. For example, if I’m a CRO, a senior executive, I would like to make sure if we are on time. The third is about traceability. I would like to make sure not only who did what and when, but what was the logic behind subject matter experts’ decisions. So these are our primary goals.

Within Verify, you can get all the outputs under one digital framework. What does that mean? The system parses all your outputs under one delivery, so all your outputs are going to be visible to any internal stakeholder.

Then you can just press a button, ready for review, and invite all your stakeholders into the same space under Verify. Then a medical writer, for example, can actually review all of the outputs at once and create an issue:  The title is not correct, the footnotes are not informative, and so on. Instead of reviewing output by output, you can create an issue on 100 outputs in a second. Once the medical writer  places an issue, their issue is saved in one place, called the Activity Log, or audit trail. And then it’s added automatically into the task management of the statistical programmer.

Now, going back to the current state of the industry – today, a statistical programmer needs to aggregate all of the issues, coming from emails, Excel sheets, comments, etc., into one Excel sheet. It takes a lot of time just to aggregate everything in one Excel sheet. And coming from the software industry, we said, Hey – why not just bring all the methods from our industry into the important clinical review process.

Névine Zariffa: And that’s something that I really like about Beaconcure, and one of the reasons I agreed to be a scientific advisor to the company: you took the time to really understand and work with experts in clinical trials. You didn’t just come in with your technical software know-how, pretend like you knew – you took the time to educate yourself. That’s impressive, and I’m glad that the market is seeing the value of your tool now.

I’d like to close out with a question for you around what’s next: What are you going to tackle next? Because you took a very methodical, some might call it slow, path to make sure that your AI was working properly, that your automation was hitting the mark. You trained on hundreds of clinical trials to convince yourself and potential clients that you had it right. That’s for validation, then you put a layer on it for communication, then you put a layer on it for dashboards. What are you hoping to solve next?

Ilan Carmeli: We are going to offer to the market three main things. One is generating the statistical outputs automatically. The second is offering a resource management platform for CROs and sponsors, to manage their resources in an agile approach instead of a linear process. And the third is the infrastructure that supports such elements – implementing, modifying, and training current LLM to fit our industry.

Névine Zariffa: Those sound like fantastic offerings. They’re going to hit the mark at multiple levels throughout the layers of big, complex companies. And I guess you’re going to promise us to do that work just as methodically and accurately as you’ve been working to date.

 Ilan Carmeli: Yes, this is our promise. Thank you very much for the great discussion and looking forward to the future. 

Névine Zariffa: Absolutely, and good luck to you and your team.

Ilan Carmeli: Thank you.