Dr. Harsha Rajasimha is a globally recognized authority on AI‑enabled, patient‑centric clinical trials and the visionary Founder & CEO of Jeeva Clinical Trials, an award‑winning SaaS platform that accelerates decentralized and hybrid studies across oncology, rare diseases, dermatology, obesity, and other high‑impact therapeutic areas.
With more than two decades of experience spanning the NIH, FDA, and biopharmaceutical R&D, Dr. Rajasimha blends deep expertise in genomics, precision medicine, and digital health with a passion for eliminating barriers to patient participation. Under his leadership, Jeeva’s Unified‑or‑Modular CTMS harnesses advanced artificial intelligence, real‑world data, and multilingual clinical research workflows to cut trial timelines by up to 38 %, reduce site burden by 60 %, and improve retention among medically underserved populations worldwide.
A serial entrepreneur and rare‑disease advocate, Dr. Rajasimha chairs the Indo‑US Bridging RARE Summit and advises international patient‑advocacy organizations on health equity in research. His thought leadership—featured in Clinical Leader, Pharmaceutical Outsourcing, PharmacyTimes, Rare Revolution Magazine, and peer‑reviewed journals—positions him at the forefront of discussions on digital transformation, AI governance, and regulatory compliance (21 CFR Part 11, GDPR) for next‑generation trials.
Honored with the Virginia Innovator of the Year Award, SBIR grants, and recognition from the AWS Healthcare Competency program, Harsha Rajasimha continues to champion data‑driven innovation that democratizes access to life‑saving treatments. He holds a PhD in Bioinformatics and Genomics from Virginia Tech, has authored over 40 scientific publications, and is an invited keynote speaker at Outsourcing Clinical Trials conference, World Orphan Drug Congress, National Minority Quality Forum, RARE Advocacy Summit, Bio-IT World, and speaks at events organized around BIO and JP Morgan Healthcare conferences.
Connect with Dr. Harsha Rajasimha on LinkedIn to learn how his mission‑driven leadership at Jeeva Clinical Trials is shaping a smarter, faster, and more inclusive future for global clinical research.
Dr. Harsha Rajasimha is a globally recognized authority on AI‑enabled, patient‑centric clinical trials and the visionary Founder & CEO of Jeeva Clinical Trials, an award‑winning SaaS platform that accelerates decentralized and hybrid studies across oncology, rare diseases, dermatology, obesity, and other high‑impact therapeutic areas.
With more than two decades of experience spanning the NIH, FDA, and biopharmaceutical R&D, Dr. Rajasimha blends deep expertise in genomics, precision medicine, and digital health with a passion for eliminating barriers to patient participation. Under his leadership, Jeeva’s Unified‑or‑Modular CTMS harnesses advanced artificial intelligence, real‑world data, and multilingual clinical research workflows to cut trial timelines by up to 38 %, reduce site burden by 60 %, and improve retention among medically underserved populations worldwide.
A serial entrepreneur and rare‑disease advocate, Dr. Rajasimha chairs the Indo‑US Bridging RARE Summit and advises international patient‑advocacy organizations on health equity in research. His thought leadership—featured in Clinical Leader, Pharmaceutical Outsourcing, PharmacyTimes, Rare Revolution Magazine, and peer‑reviewed journals—positions him at the forefront of discussions on digital transformation, AI governance, and regulatory compliance (21 CFR Part 11, GDPR) for next‑generation trials.
Honored with the Virginia Innovator of the Year Award, SBIR grants, and recognition from the AWS Healthcare Competency program, Harsha Rajasimha continues to champion data‑driven innovation that democratizes access to life‑saving treatments. He holds a PhD in Bioinformatics and Genomics from Virginia Tech, has authored over 40 scientific publications, and is an invited keynote speaker at Outsourcing Clinical Trials conference, World Orphan Drug Congress, National Minority Quality Forum, RARE Advocacy Summit, Bio-IT World, and speaks at events organized around BIO and JP Morgan Healthcare conferences.
Connect with Dr. Harsha Rajasimha on LinkedIn to learn how his mission‑driven leadership at Jeeva Clinical Trials is shaping a smarter, faster, and more inclusive future for global clinical research.
After experiencing the profound loss of a child to a rare disease in 2012, Harsha dedicated his years of post-doctoral research experience to accelerating the development of diagnostics and treatments for patients, focusing particularly on neglected rare diseases.
Harsha’s passion led to the founding of Jeeva Clinical Trials Inc., aimed at reducing the timelines for clinical research and the development of treatments for rare genetic diseases.
The company strives to alleviate the burden on patients, caregivers, and researchers by creating AI-driven technology solutions that address barriers and bottlenecks in the clinical research processes.
Harsha excelled in education, completing Ph.D. in Genetics, Bioinformatics
and Computational Biology, M.S. in Computer Science and Applications, and B.E. in Computer Science and Engineering.
From the beginning of his career, Harsha has embraced the interdisciplinary nature of biomedical research, broadening his understanding beyond computer science and big data to encompass basic biology, biochemistry, genetics, genomics, health, aging, and disease.
Additionally, he has successfully utilized community science and consortium approaches to contribute to the development and adoption of community data standards.
Harsha’s global involvement in rare disease patient advocacy has led him to adopt the FDA’s patient-focused drug development paradigm, driven by a sense of urgency and the necessity to effectively communicate complex scientific and technical discoveries to broader patient and caregiver communities.
His commitment translates basic, clinical, and translational research into tangible public health benefits.
Research Associate Software Engineer, Virginia Bioinformatics Institute, Blacksburg, VA
Genomics Contractor, NCI CBIIT, and National Eye Institute, NIH, Bethesda, MD
Executive Director, Genome International Corporation, Madison, WI
LIMS Technology Contractor, Food and Drug Administration, Rockville, MD
Adjunct Faculty, School of Systems Biology, George Mason University, Fairfax, VA
Founder and CEO, Jeeva Clinical Trials Inc.
Co-Founder and Co-Chair, Organization for Rare Diseases India and USA, Herndon, VA
Vice President of Global Business Development, Strand Life Sciences
Lead Managing Consultant, Life Sciences R&D, NTT DATA Services, Plano, TX
Founder and Chairman, Indo-US Organization for Rare Diseases, Herndon, VA
Member, Biological Pathways Data Exchange (BioPAX) International consortium
Reviewer, Molecular Vision
Data-Enabled Life Science Alliance (DELSAGlobal)
Member, American Society of Clinical Oncology
Member, American Society of Human Genetics
Member, Healthcare Information and Management Systems Society, Inc. (HIMSS)
Member, Rare Global Advocacy Leadership Council
Undiagnosed Diseases Network International (UDNI)
International Rare Diseases Research Consortium (IRDiRC)
Board of Advisors, Synergy Business Innovation & Solutions, Inc.
Reviewer, Orphanet Journal for Rare Diseases
Working group, DEIA in rare disease research & clinical trials, rare disease diversity coalition
Chairperson, Indo US Bridging RARE Summit
2012: NEI, NIH Director’s Innovation Award for outstanding contributions towards setting up next-generation sequencing computational infrastructure leading to publications.
2014: Bioscience Company of the Year, Montgomery County Economic Development, Maryland, USA
2016: Sanofi Genzyme Patient Advocacy Leadership Award with Rare Genomics Institute
2017: NTT DATA Healthcare Life Sciences Silver Award for outstanding achievement toward fiscal goals
2019: Rare Diseases International Travel Award to represent the Organization for Rare Diseases India on the NGO Committee on Rare Diseases at the United Nations and at the high-profile launch of the global Commission report on ending diagnostic odyssey for children with a rare disease at Microsoft headquarters, NYC
2019: Innovation in Rare Diseases Award from Lead India 2020 Foundation
Jeeva Clinical Trials Inc.