The pandemic is a disruptive force like never experienced before. COVID-19 is significantly impacting clinical trial oversight and the ability for on-site monitoring. Regulators have come out with guidance that recommends the use of centralized monitoring and remote monitoring tools and technologies. This is an area where ThoughtSphere excels. Established in 2015, the company offers an application that is a comprehensive analytics and risk-based monitoring solution for clinical trial oversight. The organizations who have been leveraging ThoughtSphere capabilities for clinical monitoring are relishing highly efficient processes and cost savings up to 30%.
Regulators have encouraged the biotechnology industry to adopt new technologies to transform processes, but for a variety of reasons, the industry has been slow to adapt. This could be because of perceived risk, internal organization or cultural barriers, or the recognition that technology alone doesn’t solve these problems. The people and process challenges can be significant. Sudeep Pattnaik, CEO and Founder of ThoughtSphere expresses, “But, I think everyone is having to rethink their operations and their business models and I think the ultimate long term effect is the acceleration of the digitalization of clinical trials. You’re going to see more of a hybrid approach with clinical trials including virtual trials and a focus on how risk-based monitoring can support remote/centralized monitoring.”
ClinHUB: A Patented Source-System-Agnostic Data Collation
ThoughtSphere started with the mission to help life science companies develop and deliver treatments to patients faster and smarter using data science. At the core, the company wants to transform clinical trial processes to increase patient safety, improve trial quality, and decrease the cost of bringing new treatments to market. ThoughtSphere Cloud is a clinical data and analytics platform that has four fundamental product offerings.
ClinHUB is at the core of the platform—a patented source-system-agnostic data collation and aggregation hub, enabled by AI and ML, that can be deployed in days or weeks. A ThoughtSphere customer has publicly described an order of magnitude difference in the time to integrate data using its platform versus traditional methods. On top of this, ThoughtSphere offers risk-based monitoring and analytics, budget planning and site payments, and data management, review, and reconciliation. The three unique reasons that make the platform exclusive from others are:
- Patented Data Integration – Recently, the platform received a patent because of how it leverages AI and ML to provide a 360-degree view of clinical trial data and adapt to any data source or format it is ingesting.
- Intuitive and Easy to Use – The platform was built keeping business users in mind in areas such as data ingestion, analytics and visualization.
- Time to Value – Clients report ThoughtSphere Cloud implementations can take only days versus standard implementations which might take weeks or months.
Making a Real Difference in the Lives of Patients
“I was running products and delivery for a large CRO and realized with big data technologies and the advances in artificial intelligence and machine learning, data science expertise could be used to significantly increase R&D efficiency,” says Sudeep. There are so many challenges facing the industry with the complexity and costs of bringing a new therapeutic to market. Sudeep feels that with technology we can start to help solve some of these challenges and make a real difference in the lives of patients. Since the inception of ThoughtSphere, Sudeep’s role has been to set the vision and strategy for the company and to see that it executes that strategy. He is pleased about where the company is today.
The company has a great set of customers and employees who are motivated and experts in this area. Motivating the team is not a big challenge. Sudeep says, “It has been a stressful few months. But, think about what’s happened in the world this year and how this has put our industry front and center.” Sudeep says all of the employees realize they have a chance to make a real difference in the world by helping their clients bring treatments to market faster and by helping to save people’s lives. ThoughtSphere has some important customers and the employees thoroughly enjoy working with them on a daily basis to help solve their problems.
Digitizing and Transforming Clinical Trial Processes
Over the years, one of the big changes in the biotechnology industry is the adoption of eSource and other electronic capture technologies. This has created a big data effect in clinical trials that requires a different approach to capturing and integrating these data. ThoughtSphere has also seen regulators respond and encourage change by removing barriers to innovation with guidance on clinical trial monitoring. The company is coping with these changes by introducing next-generation technology that leverages data science with artificial intelligence and machine learning to help solve these problems. It works closely with its customers and partners on how to use new technology, and also works with them on how to think about processes and people and how the organization needs to change and adapt.
The digitalization of clinical trails is inevitable with so much value for the industry to gain in developing new business models and by using data to drive insights and decision making. As part of the future, ThoughtSphere is looking at areas such as virtual assistants with a conversational UI that will allow business users to interact with its applications in human terms. The company is looking at how to incorporate real-world data with machine learning models for areas such as trial feasibility, optimizing trial design, patient recruitment, and safety signal detection. Furthermore, it is also looking at how to automate the very manual study build process, specifically the protocol to edit check process. The company will continue to look at how AI and ML can help digitize and transform clinical trial processes.
