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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SOURCE Jeeva Clinical Trials Inc.