Clinical trials rely on volunteer populations that can be challenging to access and monitor. Inadequate diversity in clinical trials leads to unreliable results. Dr. Harsha Rajasimha, CEO & Founder of Jeeva Informatics, is leading the way to enable greater collaboration, diversity, inclusion, and access to decentralized clinical trials, particularly for underrepresented minorities.
MANASSAS, Va., Oct. 26, 2022 /PRNewswire-PRWeb/ -- Diversity and inclusion in clinical trials are critical to achieving accurate and reliable results.(1) Participation in clinical trials is voluntary, and individuals of different ages, genders, races, ethnicities, genetic backgrounds, geographic locations, and environments will respond differently to the same treatments. An effective way to achieve diversity in clinical trials is through decentralization with standardized procedures across multiple sites.(2) To facilitate the efficient execution of multi-center clinical trials globally, Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, and his team have developed the modular Jeeva™ eClinical Cloud.
Researchers in the U.S. and abroad have selected the Jeeva eClinical Platform for their pivotal clinical trials. U.S.-based Frantz Viral Therapeutics (FVT), a joint venture of Georgetown University Medical Center and Frantz Medical Group, developed and clinically demonstrated safety and efficacy in three applications of an antiviral drug for the treatment of HPV-associated pre-invasive disease of the anogenital tract. FVT selected the Jeeva eClinical platform to effectively execute a multi-site phase 2 clinical trial focused on the treatment of anal squamous intraepithelial lesions (anal HSIL). "I appreciate the functionality of the system. The Jeeva team has been helpful in working with us to provide exactly what we needed for our pivotal study," says Mihaela Plesa, Director of Clinical Operations at Frantz Viral Therapeutics.
ImmunoACT is pioneering the first cell and gene therapy in India for patients' long-term cures, both for common and rare diseases. They chose Jeeva to accelerate clinical development timelines without tapping into a large, full-service Contract Research Organization (CRO) or creating an in-house IT infrastructure. ImmunoACT selected Jeeva as a strategic technology partner to optimize their clinical trial operations from the very early stage through study closeout and long-term follow-up. "We need to bring the healthcare costs and product development costs down, especially in the developing world. Clinical trial costs are a significant part of product development costs. We are confident that by partnering with Jeeva, we can find the right value for money proposition without compromising on the quality," says Shirish Arya, Director of Strategy at ImmunoACT.
With regional deployments of the Jeeva eClinical Cloud and TRIALMAGNET, we are able to support local regulatory requirements for the physical storage of clinical trial data and make it affordable in emerging markets with local partners and expertise on the ground.
The company has established numerous partnerships with CROs, site networks, and investigators in the US, India, and Latin America. Jeeva recently strategically partnered with MetFlux Research Services Pvt. Ltd. (MetFlux) for virtual clinical trials and software distribution in India. "Our partnership with Jeeva brings the world's first-of-its-kind clinical research service, combining MetFlux's Investigative PhysiologyTM platform with Jeeva's eClinical trials platform. The partnership enables end-to-end pre-clinical and clinical trial solutions to pharma and healthcare companies seamlessly linking deep physiology research, advanced research analytics with the scalable digital clinical trial execution, and outstanding customer support," says Professor Venkatesh Kareenhalli, Founder and Director of MetFlux.
U.S.-based Koncord Clinical Research Services (KCRS) needed a mobile-friendly software platform for engaging diverse patients in the Texas-Mexico border region. With Jeeva eClinical Cloud, the team is gathering accurate and faster eConsent, followed by biospecimen collection from elderly Hispanic persons with liver and gastrointestinal disorders. "In looking for a software partner, our research coordinators and investigators in the field could call the Jeeva team anytime, get reliable support, and have reassurance as we enroll patients on the go. You can count on Jeeva when time is of the essence in operationalizing a clinical trial," attests Dr. Emmanuel Gorospe, Chief Medical Officer of KCRS.
Farmacon Global, a strategic CRO based in the U.S. with an extensive reach to clinical research sites in Latin America and outreach ability to Latinos in the U.S., recently partnered with Jeeva eClinical Platform to enable the Hispanic and Latinx communities with rare diseases, opportunities to access therapies in clinical trials. "Having evaluated numerous clinical trial platforms, Jeeva was refreshing in its vision to engage underrepresented minorities, focus on rare diseases, and collaborative approach beyond technology. We are eager to enable patient education, recruitment, and retention in rare disease clinical studies, such as patient registries and cell/gene therapies," says Sara Tylosky, CEO of Farmacon Global.
Based on his lived experiences of caring for young loved ones with rare and chronic conditions, Dr. Rajasimha is driven to help patients gain access to critical and life-saving therapies faster and with the least burden. He says, "Empowering remote patient-researcher interactions through the use of human-centric digital technology enables us to deliver dramatic improvements in the diversity of study populations scalable to a variety of clinical trials with rapid configurations rather than building a custom app each time."
The globalization, decentralization, and diversification of clinical trials are just beginning, but the future is bright.
About Jeeva Informatics Solutions
The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company's modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/
References:
1. U.S. Department of Health and Human Services. "Diversity & Inclusion in Clinical Trials." Updated February 7, 2022, National Institute on Minority Health and Healthy Disparities, nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html.
2. Homedes, Nuria; Ugalde, Antonio. "Globalization and Clinical Research in Latin America." January 2014, Clinical Trials in Latin America: Where Ethics and Business Clash (pp.55-78), researchgate.net/publication/290735135GlobalizationandClinicalResearchinLatin_America.
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SOURCE Jeeva Informatics
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