Envisioning AI’s Risk Identification and Mitigation

Raj Indupuri, CEO, eClinical Solutions

Pharmaceutical Executive: How do you envision AI improving risk identification and mitigation, and what impact might this have on trial outcomes and regulatory compliance?

Raj Indupuri: This is another big area as an industry. We have been having conversations for more than a decade, terms of taking risk-based strategies and embedding quality all along the value chain, and there is guidance as well for regulatory authorities. So as we work with customers, we have seen a trend, I would say, beyond a trend, strong push to embed quality right up and also think of risk right from protocol design as we start the trial, conduct the trial, and when it comes to cleaning the data right, getting insights right.

So having this risk-based strategies is important, because we talked earlier in terms of the amount of data that’s increa sing, right? In other words, like, you made a count earlier, in 13 years, you’ve gone up from 900k data points to 6 million data points. If you don’t have, if you cannot take, or if you don’t take risk-based strategies, it’s going to be very critical, or it will difficult, I would say, to focus on quality and also manage risk, right?

The guidance and also the industries now, approach is to take different strategies based on criticality of the data, right? So that’s a big push or a change. So risk based strategies and thinking about quality management and risk management integrated with data review is going to become an imperative approach, and we as a company are well positioned to do it, because on top of our strong data infrastructure, we have different data products to support data review, do risk based quality management, do help with overall conduct, with capabilities like React.

So we have an advantage here, where we have all these data products that coexist and they’re integrated, and we are also leading this intelligence I referred to so we firmly believe it has to be an integrated approach, where you think about risk upfront, and it not only yields to better results, but also can reduce costs and also increase quality.

Raj Indupuri

CEO, eClinical Solutions

A technologist with over 25 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions. Raj is responsible for the overall direction and management of the company and is a Mechanical Engineer with an MBA from Boston University who firmly believes data is the new fuel that will drive human progress.