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Cancer Moonshot Gets a Booster Shot from This AI-Driven Clinical Research Platform


President Biden’s loss of his beloved son to brain cancer in 2015 inspired the Cancer Moonshot initiative. Dr. Harsha Rajasimha’s inspiration for founding Jeeva Clinical Trials in 2019 stemmed from a similar incident: losing his precious baby to a rare disease. This ignited a fire within him to prevent such tragedies from striking other families. Driven by a proven and validated solution, Jeeva’s new Enterprise platform launch aims to accelerate clinical research for life-saving therapies for cancer, rare diseases, and chronic illnesses that are more inclusive of underserved communities than ever before.

MANASSAS, Va., May 13, 2024 /PRNewswire-PRWeb/ — The clinical trial landscape is marred by persistent operational inefficiencies that have only been marginally addressed by the proliferation of technology and the shift to remote trial operations. 2024 is seeing a surge in the fight against cancer, with cancer clinical trials dominating the rest. (1) Dr. Rajasimha notes, “Despite the AI revolution, digital transformation initiatives, and the advent of remote operations, the core goals of clinical trials—to assess the safety and efficacy of treatment options—remain unchanged. They are also getting increasingly inefficient, expensive, longer, and complex due to short-sighted point solutions that address specific parts of the drug development process. We need comprehensive solutions to this nagging problem – a piecemeal approach has resulted in 90% failure rate of candidate drugs in the ‘valley of death’ and 30% trial terminations due to poor enrollment.” (2)

Traditional Clinical Trials Face Critical Challenges, Including:
1.    Fragmented data management due to the need for 10-30 different digital tools and logins leading to inefficient data integration, interoperability, management, and manual workflows, resulting in fragmented data and increased risks. (3)
2.    Adapting to hybrid and remote decentralized research sites and workforce poses significant operational challenges and demands of remote accessibility and the need for remote monitoring technologies. (3)
3.    Patient recruitment and patient retention is the biggest challenge because about 90% of clinical trials are restricted to the US and EU representing under 10% of the global population. (4)
4.    Even within these regions, only about 5% of target patients living within a 50-mile radius of major academic medical centers are likely to participate due to logistical burdens.
5.    Complex and inconsistent regulatory guidelines, particularly when expanding into new and emerging markets needing support in 100+ languages, add uncertainty to trial operations. (5)
6.    High costs for sponsors are both due to direct costs of the inefficient process and indirect cost of avoidable operational delays. (6)
7.    Geographical dispersion of patients is leading to recruitment difficulties. Clinical research studies for cancer and rare diseases encounter difficulties in recruiting participants due to sparse geographic distribution, lack of integrated datasets for high throughput screening of eligible patients, and a large proportion of screen failures. (7)

Relevance to the Cancer Moonshot Initiative
Inspired by Pulitzer Award-winning author Siddhartha Mukherjee’s book, “The Emperor of All Maladies,” which narrated a biography of our global enemy, Dr. Rajasimha acknowledges cancer’s complexity, comprising over 200 subtypes. This varies based on the affected body part of origin or the cell type. To combat this, he emphasized the need for cutting-edge science and flexible, validated technology platforms that address the “whole problem” and not a piecemeal approach. The one-size-fits-all blockbuster drug model has fallen out in favor of personalized medicines, but technologies for clinical operations have not adapted to this paradigm yet. Rajasimha’s vision for JEEVA’s flexible AI-driven software platform helps overcome protocol complexity for precision medicines and automate procedure assignments, appointment scheduling, and study management. His commitment aligns with the audacious goals of the Whitehouse’s Cancer Moonshot initiative, forging a powerful partnership towards excellence in Cancer clinical research and treatment.

Jeeva’s Platform Is Set to Revolutionize Global Cancer Research with Unparalleled Precision and Inclusivity

  • Jeeva is turning the traditional CRO (contract research organization) model upside down. Jeeva is effectively transforming the manual, repetitive, inefficient, time and materials model that has prevailed in the western world into an automated software suite or unified platform in a subscription-based model for researchers and patients on a global scale. The innovative model is enabling the next generation of complex clinical studies from protocol to publication under a single centralized login for each user.
  • Empowering patient engagement in over 100 languages helps address the historic underrepresentation of 90% of the World’s population during research, development, real world data (RWD) capture, and commercialization of treatments for cancer.
  • Harnessing cutting-edge technologies like AI, driving breakthroughs in precision cancer treatment options, as validated by recent NIH research.

JEEVA’s comprehensive eClinical platform is meticulously crafted to streamline the major components of both observational and interventional clinical studies at an enterprise scale, infusing every aspect with a relentless drive for efficiency, innovation, and inclusion without compromising quality and compliance.

Trusted by Leading Organizations: Accelerating Cancer Research with Jeeva
By centralizing data management and embracing the dynamic nature of the life science industry’s hybrid and distributed workforce, JEEVA confronts the challenges of global trial management head-on. With a steadfast commitment to improving patient recruitment and retention, coupled with a keen awareness of the financial and operational hurdles posed by regulatory standards, JEEVA stands as a ray of hope in the fight against cancer.

“If we can prevent cancer in the pre-malignant stage, it is far superior than trying to cure it when it has locally advanced or become metastatic. We have been pleased to work with JEEVA as our Electronic Data Capture (EDC) and clinical trial management system (CTMS) vendor to optimize our research data workflows under one login related to our clinical studies of pre-invasive HPV-induced lesions,” says Mihaela Plesa, BA, CCRP, Director of Clinical Research Projects, Frantz Viral Therapeutics LLC.
Aligned with the Cancer Moonshot initiative, Dr. Rajasimha’s vision for JEEVA embodies purpose and determination. Scientific advances worldwide connect with global Moonshot initiatives. Collaboration with emerging markets and low- and middle-income countries (LMICs) like India is crucial for affordable treatment access.

“We needed an innovative platform for our first clinical trial with minimal financial burden and not requiring us to carry a huge IT infrastructure internally. Collaboration with Jeeva was an excellent choice for our CAR-T cell/gene therapy for leukemia and B-cell lymphoma which recently received approval from the Indian regulatory agency for a tenth of the cost compared to existing CAR-T therapies. This collaboration has been really fruitful in keeping clinical data as per regulatory requirements,” says Dr. Rahul Purwar, Founder of ImmunoACT and Associate Professor at the Indian Institute of Technology (IIT), Mumbai, India.
Collaborating Physician Investigator Dr. Hasmukh Jain from the Tata Memorial Centre presented the Indian CAR-T cell/gene therapy success story during a global collaborations session at the American Society for Cell and Gene Therapy (ASGCT) conference in Baltimore last week May 7-11, 2024. The winds of change are clearly here and now!

With an unwavering confidence in the transformative power of JEEVA’s innovative platform, Rajasimha says, “With JEEVA’s innovative platform, we are uniquely positioned to revolutionize cancer research, offering flexible, efficient, and compliant solutions that empower clinical researchers working towards the core objectives of the Cancer Moonshot, and propelling us towards a future where novel, safer and more effective treatment options are developed rapidly to prevent, delay, and minimize the number of deaths due to cancer.”

To Learn More About Partnering with Jeeva’s Audacious Mission, Connect with Us at the Following Upcoming Events

  • Rajasimha will be speaking on a panel discussion focused on patient-centricity in clinical trials at the Outsourcing Clinical Trials East Coast Conference in King of Prussia, PA on May 21-22, 2024. Gain first-hand knowledge and actionable insights to optimize your clinical trial operations and drive meaningful outcomes.
  • Rajasimha will be at the BIO conference in San Diego June 2-6, 2024 participating in 1-on-1 partnering and as a founding member of the Bullpen Club at their daily side events on rare diseases and AI.

About Jeeva Clinical Trials Inc. (“Jeeva”)
Founded by Dr. Harsha Rajasimha after his deeply personal, family, and professional experiences, Jeeva’s mission to “Revolutionize Clinical Trials and Empower Outcomes” propels their innovative clinical trial management platform with AI and workflow automation under one bundled subscription. Jeeva empowers global biopharmaceutical, medical device, and nutraceutical sponsors, simplifying patient engagement and evidence generation, achieving 70% greater efficiency in research. Trusted by prestigious organizations like Frantz Viral Therapeutics and George Mason University, their technology supports diverse study designs, from traditional to fully decentralized models, across disease areas including oncology and rare diseases. With empathy and determination, Team Jeeva has developed an innovative, efficient, and compliant platform that enables sponsors to conduct clinical trials more effectively, breaking down barriers and fostering a globally inclusive and diverse participant pool. This includes facilitating remote participation. Powered by AI and automation, Jeeva is transforming the life sciences industry, one clinical trial at a time. Discover more about how Jeeva is reimagining the future of clinical trials at [https://jeevatrials.com/.

References
1.    Thompson, Nikki. “Oncology in 2024: The Clinical Trial Trends Reshaping the Role of CROs.” Clinical Trials Arena, 27 Mar. 2024, http://www.clinicaltrialsarena.com/sponsored/oncology-in-2024-the-clinical-trial-trends-reshaping-the-role-of-cros/.
2.    “Wielding AI Magic in Clinical Trials Requires a Master Plan.” Drug Discovery and Development, 16 Feb. 2024, http://www.drugdiscoverytrends.com/ai-ml-clinical-trial-data-management/.
3.    “Three Clinical Trial Resourcing Challenges to Be Aware of in 2024.” Clinical Trials Arena, 13 Feb. 2024, http://www.clinicaltrialsarena.com/sponsored/three-clinical-trial-resourcing-challenges-to-be-aware-of-in-2024/.
4.    “Clinical Trial Challenges: Patient Recruitment and Diversity | L.E.K. Consulting.” http://www.lek.com, 11 Mar. 2023, http://www.lek.com/insights/hea/us/ei/clinical-trial-challenges-patient-recruitment-and-diversity.
5.    Shleifer, Caroline. “Decentralized Clinical Trials: Navigating the Regulatory Landscape for Efficient and Patient-Centric Research.” Pubs – Clinical Research News Online, 3 Nov. 2023, http://www.clinicalresearchnewsonline.com/news/2023/11/03/decentralized-clinical-trials-navigating-the-regulatory-landscape-for-efficient-and-patient-centric-research. Accessed 29 Apr. 2024.
6.    Norris, Emily. “Enhancement, Efficiency, Equity, and Engagement: Four Trends Shaping Clinical Trials in 2024.” ACRP, 3 Jan. 2024, acrpnet.org/2024/01/03/enhancement-efficiency-equity-and-engagement-four-trends-shaping-clinical-trials-in-2024/. Accessed 29 Apr. 2024.
7.    Losasso, Mae. “Challenges of Running Clinical Trials: How Technology Could Lead to Change.” NS Healthcare, 31 Jan. 2022, http://www.ns-healthcare.com/analysis/challenges-of-running-clinical-trials-how-technology-could-lead-to-change/.

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JOTO PR™   
727-777-4619   
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Karla Jo Helms, JOTO PR™, 727-777-4629, [email protected], jotopr.com

SOURCE Jeeva Clinical Trials Inc.

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