2024-05-10

Q: Can you explain the impact of AI on managing the vast data generated in modern clinical trials?

Gaurav Josan: Over the last decade, complexity in clinical trials has increased tremendously with an average of 3.6 million data points per trial. AI offers advanced capabilities to quickly analyze vast amounts of data and perform complex calculations within seconds or even milliseconds. It’s like a superpower for humans, equipping us with quick decision-making capabilities by feeding AI-based complex analysis of the vast data points. In clinical trials, using more accurate data to make faster decisions means we can help patients by accelerating the pace at which life improving therapies can be made available.

Q: How does Clario ensure the quality and security of data in decentralized clinical trials?

Gaurav Josan: Quality and security are front and center in everything that we do here at Clario. We are in a highly regulated industry, and our customers trust us with their valuable data. The work we do at Clario is mission-critical and we have various safeguards in place every step of the process. We deploy AI, encryption, checksums, and manual human oversight to ensure robust data privacy and data quality in decentralized clinical trials. Our technology has been refined over time through the thousands of trials we have supported, ensuring it meets the highest standards of consistency and security.

Q: Can you provide insights into how AI algorithms are used to assess spirometry loops?

Gaurav Josan: The quality of spirometry data measuring the patient’s pulmonary functions can vary significantly between multiple attempts. ArtiQ AI technology addresses this issue by providing near real-time feedback related to the quality of data, allowing for instant improvements if needed. The spirometry data is analyzed using this advanced AI model in full compliance with regulatory guidelines. Clario’s recent acquisition of ArtiQ further strengthens our respiratory solutions capabilities and will ultimately expand the innovative use of AI across all our data endpoint solutions.

Q: What is Clario's strategy for scaling AI technologies across different types of clinical trials?

Gaurav Josan: When scaling AI technologies, Clario has a breadth of data endpoint solutions, scientific expertise, and global regulatory experience. This combination enables us to scale effectively and lead the advancement of AI across different types of clinical trials. We have contributed to over 800 regulatory approvals and supported more than 26,000 varied clinical trials. Our AI team works closely with Clario’s scientific and regulatory experts around the world to ensure our AI strategy is finetuned to solve complex industry problems across various types of clinical trials.

Our portfolio features over 50 AI models that provide us with a strong foundation that spans various therapeutic areas. Our AI roadmap is focused on expanding our capabilities in existing trials and further advancing into additional types of trials. Our solutions cover a wide range of data endpoints, including eCOA (electronic clinical outcome assessment), cardiac safety, medical imaging, respiratory, and precision motion. Leveraging AI, we aim to offer harmonized solutions for our clients that consist of comprehensive data endpoints to unlock better clinical evidence that can support the approval of new medical treatments for patients worldwide.

Q: How does Clario maintain a balance between technological innovation and human oversight in trials?

Gaurav Josan: Our AI models are being deployed in conjunction with human oversight, where the goal is to enhance human capabilities and accelerate clinical trial execution with quality intact. AI is a pivotal technology, but the balance withhuman oversight is critical. All of our workflows consider the balance of using technology to automate complex tasks and feed into human decision-making.

Last year, Clario made a public commitment to employing AI in a responsible way, governed by the highest ethical principles. To that end, we established a series of responsible use tenets. Those tenets are part of our triple-faceted approach for developing and analyzing the application of AI through the synthesis of technological, scientific, and legal oversight. This approach ensures Clario’s AI models and algorithms are responsibly developed and continuously refined for better quality control, better accuracy of data endpoint collection, and better patient privacy protection for our customers.

Q: What steps does Clario take to keep up with the rapid advancements in AI and ML technologies?

Gaurav Josan: At Clario, AI is not new to us. We have implemented machine learning and deep learning-based AI models for over six years. Currently, we have AI models implemented in hundreds of trials. Our dedicated AI team’s focus is not just on keeping up with advances in AI but also actively contributing to them. AI is a team sport, and Clario, given its combination of technology and scientific expertise, is actively pushing the bar of the possible. With the more recent GenAI capabilities, Clario has already implemented solutions leveraging GenAI within our workflow, accelerating initiatives focusing on speed and quality.

Q: How does the eCOA Science risk monitoring analytics solution work and what makes it effective?

Gaurav Josan: Leveraging our deep scientific expertise, we have developed a risk monitoring solution that incorporates advanced analytics to ensure the integrity of eCOA data. This solution aims to minimize risk by monitoring and analyzing trial data in near real-time. These insights equip our clients to address any issues proactively and enhance the integrity and reliability of the collected information, avoiding surprises down the road when these issues might be more challenging to resolve. At Clario, we are fully invested in the success of our customers, driven by our dedication to delivering innovative solutions that provide earlier insights and empower decision-making using robust quantitative data.