From Fragmented Clinical Trials to AI-Native Execution: Reducing Complexity in Decentralized Clinical Research
Speaker: Harsha K. Rajasimha, MS, PhD, Founder & CEO, Jeeva Clinical Trials, Affiliate Faculty, Systems Biology, George Mason University
Abstract: Clinical trials remain one of the most critical yet inefficient components of drug development, with timelines often exceeding 8–9 years and costs reaching billions of dollars. Despite advances in digital health, most trials continue to operate on fragmented infrastructure, relying on 6–10 disconnected systems and manual workflows across stakeholders. At the same time, patient participation remains strikingly low, with only ~5% of eligible patients enrolling in trials and over 90% of studies concentrated in a small fraction of countries, limiting global inclusion and diversity. Decentralized and hybrid clinical trials offer a promising path forward by enabling remote participation, real-time data capture, and broader access. However, these models introduce new layers of operational complexity, requiring coordination across patients, sites, devices, and data systems. This session will explore:
The root causes of clinical trial complexity in modern drug development;
Key differences between centralized, decentralized, and hybrid trial models;
Operational challenges in patient recruitment, retention, and data management;
The role of AI in transforming clinical trial execution from reactive workflows to proactive, intelligent systems.
Bio: Harsha is a serial entrepreneur, postdoctoral data scientist trained at NIH, global patient advocate, and investor. As the founder and CEO of Jeeva Clinical Trials Inc.(https://jeevatrials.com), Harsha is pioneering an AI-driven unified platform for sponsors and CROs to execute patient-centric clinical trials with efficiency and universal accessibility. As the Founder & executive chair of the Indo-US Organization for Rare Diseases (https://indousrare.org), Harsha is forging a new era of cross-border cooperation among various stakeholders of rare diseases in the US, India, and globally by convening the annual Indo US bridging RARE Summit (https://summit.indousrare.org) and the Abbey Meyers Khushi Bridging RARE Awards Gala. Harsha’s 20 years of experience in precision medicine data research spans academia, federally funded research, biopharma R&D consulting, and multiple startups. Harsha made bold career moves after losing a newborn child to a rare congenital disease in 2012 and his younger brother with juvenile diabetes in 2017. He decided to apply his years of postdoctoral training at NIH and FDA to combat rare diseases.