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.
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.
The Jeeva eClinical Cloud™ was developed by researchers with empathy who listen and learn to help clinical researchers, hospital sites, academic medical centers, CROs, and biopharmaceutical sponsors accelerate patient enrollment by 3x faster.
Delays in patient recruitment and retention, ensuring diversity, equity, and inclusion, generating quality clinical evidence of safety and efficacy of treatments, tracking patients adherence to medication, and compliance with regulatory agencies such as Institutional Review Boards, FDA, EMA, GDPR, and other guidelines are critical factors.
85% of clinical trials are delayed due to the slow pace patient enrollment. 30% of clinical trials fail because they cannot meet their target enrollment. Every day delayed causes biopharmaceutical sponsors a loss of $600K to $8M. Patient recruitment involves identification of patients matching the inclusion & exclusion criteria for the specific clinical trial. Most patients screened do not match. Then, enrolling those small number of matching patients into the study. Only about 3% of matching patients are choosing to enroll in clinical trials. 1 out of 4 patients not enrolling cite logistical burden as the primary reason.
The randomized controlled clinical trials have been historically successful in enrolling Caucasian adult male participants from affluent backgrounds. Less than 10% of clinical trials include children. Women and minorities are less likely to participate in clinical trials as they have more logistical burdens and special needs such as childcare, transportation, and loss of pay.
Clinical research involves generation of high quality reliable clinical evidence of patient safety and outcomes. The traditional model of generating evidence during patients’ in-person visits to brick-and-mortar sites can no longer be solely relied on. Researchers and patients are questioning traditional models and seeking increased flexibility in the post-pandemic world.
Sponsors and regulators rely on the evidence generated by study volunteers’ use of Investigational new therapies as prescribed by their investigators in the approved clinical trial protocols. If patients miss medication routine or deviate from the protocol, that may deny the therapy its fair chance of demonstrating efficacy. Hence, ensuring that study participants adhere to clinical protocol is a critical factor.
Clinical trials are highly regulated at various levels including by institutional review boards (IRBs), human subjects protection guidelines, Good clinical practice (GCP) guidance by international code of harmonization (ICH) E6 R2, data protection guidelines guidelines such as GDPR, and other local or regional guidelines. The burden of ensuring regulatory compliance of technology solutions deployed in a clinical trial rests with the sponsors. Hence, adoption of newer innovative technologies introduces risks for sponsors.
Patients are the center of clinical research. They are critical partners and not “subjects”. Yet, many clinical trials fail to incorporate patient voices early during clinical trial protocol development or logistical planning. Educating and informing patients about the goals of the trial and gathering their inputs are critical success factors.
After suffering the loss of a child to a rare congenital disorder, Jeeva founder and CEO Dr. Harsha Rajasimha applied his years of postdoctoral training in the United States at the National Institutes of Health and the U.S. Food and Drug Administration, as well as his work in the life science industry, to accelerating treatments for rare diseases by eliminating bottlenecks in the clinical trials process.
Jeeva identified travel requirements for clinical trial patients as a major barrier to recruitment and retention. The COVID-19 pandemic is accelerating the demand to decentralize the way clinical trials are conducted. Sponsors, investigators, regulators, and participants are all embracing the potential of digital technologies to reduce the cost, increase the speed, and ease the burden on participants in these studies.
Headquartered at Manassas, 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.
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 is a premium eClinical cloud solution that helps you reach your recruitment and retention targets sooner.
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.
Disruptors are defined by several characteristics. They see beyond the existing status quo and challenge it by visualizing improvement and the outcome of that solution. Innovators do not provoke anger for its own sake, but they are not afraid to upset the competition or even potential allies. They are pioneering that solution not only to help themselves but also fix an issue that has long been plaguing their industry.
1 December 2021*Did you know that 80% of participants of randomized, controlled clinical trials are Caucasian males or that less than 10% of those trials included children? Furthermore, women and minorities are much less likely to participate in these clinical trials due to logistical concerns that are logistical barriers such as childcare, transportation, loss of pay and local infrastructure.
23 November 2021The clinical trial industry must proactively address a record of “historical errors and misbehavior” in its treatment of minority populations if it wants to rebuild trust and increase patient involvement, says Dr. Harsha Rajasimha of Jeeva Informatics.
16 November 2021Minorities, based on historical mistrust in medical research, have a low participation rate in vaccinations and clinical trials. Dr. Harsha Rajasimha of Jeeva Informatics describes the urgency of this problem and suggests ways modern technology-enabled study structure can help address it.
15 October 2021Clinical 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.
21 September 2021Over 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.
2 September 2021In 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.
31 August 2021Patient 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.
20 July 202134 small technology-focused businesses to receive grants in inaugural round of Commonwealth Commercialization Fund awards
20 July 2021Jeeva 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.
16 November 2020In 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.
14 September 2020Startup takes clinical trials to the homes of patients through utilisation of digital health technologies to aid in bringing new medicines to market.
13 July 2020Thank you for submitting the form. Your enquiry will be submitted to the company.