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.

AI-driven decentralised clinical trial development platform

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.

Accelerate patient recruitment and retention

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.

Maximize diversity, equity and inclusion

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.

Generate reliable clinical evidence

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.

Maximize Patient Adherence to Medication

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.

Minimize regulatory risk and maximize compliance

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.

Walk the talk of patient-centricity

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.

About Jeeva

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 investors and partners including CIT Gap Funds, KiwiTech and numerous angel investors, including senior executives from top 20 biopharmaceutical companies.