The loss of his daughter to a rare congenital disorder in the United States and the passing of his younger brother in India from complications arising from juvenile diabetes had a profound effect on Dr. Harsha Rajasimha. These two life-changing events led him to apply his post-doctoral training at the National Institutes of Health and the U.S. Food and Drug Administration (FDA) to accelerating therapies for both rare and common conditions.
The idea for his company, Jeeva Informatics Solutions, Inc., grew from those experiences and was later guided by a thousands of stakeholder interviews. It also kindled his passion to find new ways for patients with rare diseases or patients in distant areas to have access to clinical trials.
"We wanted to eliminate bottlenecks in the clinical trial process," says Rajasimha. “Initially, the response for remote or virtual solutions was lukewarm from the biopharmaceutical community, but when the COVID-19 pandemic forced people and companies to do things differently, suddenly our idea is gaining accelerated and inbound interest.”
By identifying travel requirements as a major impediment for recruiting and retaining patients in clinical trials, Rajasimha and his team developed the Jeeva eClinical Cloud™ platform to decentralize clinical trials operations at scale. They knew that if they could harness technology while meeting stakeholder needs and regulatory requirements, they could create a patient-centered design to guide their continuous learning digital platform.
Through the George Mason University ICAP program in 2018, Rajasimha.and his partners qualified to participate in the National Science Foundation Innovation Corps (NSF I-Corps) program in 2019, which involved a $50,000 grant. With that grant, they were able to conduct thousands of stakeholder interviews between 2019 and 2021. These interviews included key decision-makers of clinical operations, researchers, influencers, regulators, patients, and end-users. These interviews guided the development of their software platform, which had to have funding to get started.
"Through telling our story over and over again, we were able to convince investors to help us raise the capital we needed," says Rajasimha. "While we were in our first pre-seed round, a stranger who heard me speak at a conference came up to me and said ‘Count me in!’ I had tears in my eyes as we secured our first investor."
Although Jeeva has received investments from more than 20 individual and institutional investors, the team pursued a Prince William County Department of Economic Development IGNITE program grant to further expand their work on the eClinical Cloud technology.
Jeeva Informatics Solutions, Inc. won an IGNITE program grant, a competitive non-dilutive grant offered by Prince William County Department of Economic Development with a $25K cash grant for early-stage companies and $50K for companies with funding.
Jeeva’s vision is to accelerate patient recruitment and evidence generation globally with their human-centric technology. By digitizing and automating manual repetitive tasks and minimizing the logistical burdens on patients and study teams, customers using the Jeeva platform can expect to accelerate patient enrollment in clinical studies by more than three times faster than before.
Traditional screening methods can be expensive, burdensome and time consuming, so the artificial intelligence-driven Jeeva platform enables a remote screening, education and recruitment process that saves both time and money for study start-up, while still providing high-quality data that meets the common needs of many disease areas and trial types. By eliminating the need to stitch together piecemeal tools approach, the Jeeva eClinical Cloud provides a platform technology for conducting these types of studies from one login.
“Helping patients learn about clinical studies that they can participate in from the comfort of their homes is what Jeeva is all about," says says Rajasimha. "We navigate all of the guidelines and constantly update the system, so we continue to meet FDA and relevant regulations.”
The eClinical Cloud works both ways—it helps patients find and learn about clinical trials they can participate in, but it also helps researchers find, screen, educate and enroll the patients they need for their clinical trials. The eClinical software-as-a-service (SaaS) platform allows participants and researchers to access the study from any browser-enabled mobile device, allowing them to minimize travel burden, maximize safety by minimizing risk of exposure to infections during the pandemic, become decentralized, and flexible to ensure continuity and integrity of research studies.
"There are over 88,000 clinical trials going on right now. As we continue to grow and adapt to the market demands, we would like to be a significant part of connecting researchers and patients across the world," says Rajasimha. "We’ll continue to grow our team and maximize patients and researchers engagement. It’s a way to give people real hope in their fight against rare and chronic diseases."
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