Jeeva Founder and CEO, Dr Harsha Rajasimha shares his personal journey that led him to decide to dedicate his years of postdoctoral research experience at National Institutes of Health (NIH) and US Food and Drug Administration (FDA).
Jeeva Informatics Solutions (Jeeva) is a seed-stage start-up on a mission to develop artificial intelligence (AI)-driven decentralised clinical trials and optimise patient-focused clinical research.
The Jeeva Trials solution reduces patient travel burden by replacing in-person trial site visits with videoconferencing, remote data collection, and digital engagement.
Jeeva is particularly beneficial for both rare disorders and clinical research studies involving long-term follow-ups and safety monitoring.
Jeeva is a member of numerous life science membership organisations, including Virginia BIO, BioHealth Capital Region and the Global Genes Corporate Alliance.
Jeeva Informatics Solutions
AI-driven decentralised clinical trial development platform
Guided by fundamental customer insights gained from more than 300 customer discovery interviews (NSF I-Corps grant) in the last year, Jeeva has validated the key customer pain points and value propositions. The current cost and time to bring innovative medicines to market are unsustainable.
Jeeva’s AI-driven decentralised clinical trials software-as-a-service (SaaS) platform helps investigators and leaders responsible for global clinical trial operations accelerate timelines, saving them more than 60% in costs while reducing travel by 50% to 80%.
Using the Jeeva SaaS platform, customers can rapidly enrol and engage geographically distributed diverse patients from their own home.
We enable our customers with a highly configurable software platform with centralised monitoring dashboards for clinical trial teams to set up, engage and empower their trial participants with the option of participating using the Jeeva’s BYOD (bring your own device) mobile app.
Participants can choose in-person or video conferencing visits based on their preference or as required by the clinical protocol and experience enhanced user experience / satisfaction. Jeeva’s AI engine is set up to learn from past clinical trials to automatically guide the next trial towards operational efficiency and maximise the probability of trial success.
Applications supported by decentralised SaaS platform
Cell and Gene therapies are the most advanced form of one-and-done treatments for patients with rare genetic diseases including cancer. US Food and Drug Administration (FDA) guidelines in January 2020 require sponsors of such therapy trials to monitor patients over extended periods of time to better understand the durability of these treatments.
A majority of existing clinical trial management or electronic data capture tools were designed for traditional brick and mortar clinical trials that usually span under a three-year duration. Jeeva offers bespoke solutions for five, ten or 15-year long-term follow-up studies.
We also deal with real-world evidence studies to collect electronic patient-reported outcomes data for a variety of therapeutic areas with flexible forms and questionnaires.
In advancing drug development programs for rare diseases, high-quality patient registries and natural history databases are often critical prerequisites. Jeeva’s SaaS platform enables patient advocacy groups with limited budgets to collect high-quality patient-level data over long durations of five, ten or 15 years, cost-effectively.
Investigator-initiated single-site studies suffer from a lack of funding and scalable software solutions necessary to conduct certain large-scale real-world evidence or observational or drug repurposing studies. The Jeeva SaaS platform offers a cost-effective solution to quickly establish and conduct clinical studies of any scale or duration with limited or no patients’ travel involved.
Unified, highly configurable and AI-driven platform
Features of Jeeva’s AI-driven platform include:
- A simple user interface (UI) / user experience (UX) for patients and clinical trial teams
- The clinical trial administrator can configure complex clinical trials and schedule of events for all users and participants
- Digital engagement features such as voice-enablement, rewards points, and gamification aimed at long-term retention
- AI assistant and dashboard for trial operations for real-time optimisation
- Highly secure, scalable, and compliance with Health Insurance Portability and Accountability Act (HIPAA), code of federal regulations and General Data Protection Regulation (GDPR) guidelines
- Unified and modular design means a reduced number of vendors and software tools to deal with. You can choose one or multiple modules for supporting decentralised clinical trials, including:
• Pre-screening for subject eligibility
• Electronic informed consent
• Electronic patient-reported outcomes
• Electronic clinical outcomes assessment
• Video conferencing visits
• Electronic diary and adverse event reporting, and
• Multi-way scheduling calendar management.
Decentralised clinical trial technologies in the Covid-19 era
In the Covid-19 era, everything must be virtual, and all clinical trial stakeholders, including regulators, are fast eliminating barriers to the adoption of mobile and decentralised clinical trials technologies.
Jeeva fills an urgent need to maintain trial integrity and continuity.
Jeeva aims to reduce patients’ travel burden in clinical trials and accelerate timelines for cell or gene therapy long-term follow-up studies or real-world evidence.
After suffering the loss of a child to a rare congenital disorder, Jeeva’s founder, Harsha K Rajasimha, decided to apply his years of postdoctoral training at National Institutes of Health (NIH), FDA, and the life science industry, to accelerate treatments for rare diseases by eliminating barriers and bottlenecks in clinical trials.
Headquartered at Fairfax, Virginia, US, Jeeva is supported by venture capital from Pritt Investment Partners, CIT Gap Funds, KiwiTech and numerous angel investors, including senior executives from top 20 biopharmaceutical companies.
Clinical trials are the regulatory mechanisms agencies like the Food and Drug Administration (FDA) use to evaluate and review evidence of safety and efficacy of investigational medicines in humans.
When clinical investigators and study coordinators start planning a new study design in the new normal, speed and efficiency are paramount.
Our Jeeva Clinical cloud-based software provides a seamless solution that improves the experience of investigators and patients by decentralizing clinical trials.
Clinical trials of new drugs and treatments have a high failure rate. Better planning and technology-aided communication, says Dr. Harsha Rajasimha of Jeeva Informatics, can significantly reduce the number of participants who drop out, thus improving the chances of success—for the trials and the therapeutic product itself.
Over the last two years, testing of new drugs, medical devices, and vaccines has increasingly been done outside large medical centers. To benefit both sponsors and patients, Dr. Harsha Rajasimha of Jeeva Informatics, urges further decentralization of the clinical trial process.
Health Tech: Harsha Rajasimha on How JEEVA’s Technology Can Make an Important Impact in Our Overall Wellness
In recent years, Big Tech has gotten a bad rep. But of course many tech companies are doing important work making monumental positive changes to society, health, and the environment. To highlight these, we started a new interview series about “Technology Making An Important Positive Social Impact”. We are interviewing leaders of tech companies who are creating or have created a tech product that is helping to make a positive change in people’s lives or the environment. As a part of this series, I had the pleasure of interviewing Harsha K. Rajasimha.
Patient test groups for new drugs and treatments, notes Dr. Harsha Rajasimha of Jeeva Informatics, tend to be non-diverse. However, recently developed digital health technologies can help broaden participation while reducing the logistical burden on both patients and study teams.
Governor Northam Announces $3.4 Million to Advance Research Commercialization in Key Technology Sectors
34 small technology-focused businesses to receive grants in inaugural round of Commonwealth Commercialization Fund awards
Jeeva is Calling for Early Adoption of their Remote Touchless Participant Recruitment and Electronic Informed Consent Platform
Jeeva is soon launching its Cloud-based HIPAA compliant remote touchless electronic informed consent software (SaaS) to empower you to screen participants for eligibility and securely enrol them in your studies from the convenience of their own homes and mobile devices.
In this interview from Rare Disease Day 2020 at the National Institutes of Health (NIH), Bethesda, MD, Ilana Bean talks to Harsha Rajasimha, the CEO and founder of Jeeva Informatic Systems about how clinical trials can change to better meet rare patient needs-- in the US, India, and across the world.
Startup takes clinical trials to the homes of patients through utilisation of digital health technologies to aid in bringing new medicines to market.