Dr. Harsha K. Rajasimha
Founder and CEO of Jeeva Informatics Solutions Inc.
Founder and CEO of Jeeva Informatics Solutions Inc.
CoFounder Board Director of the Organization for rare diseases India, USA; 501(C)(3) tax exempt organization building collaborative bridges between US and India.
After losing a child to a rare congenital disease in 2012, Dr. Rajasimha got determined to apply his years of post-doctoral clinical genomics data research experience at National Institutes of Health and industry product development experience to develop products and solutions to help accelerate clinical research. Dr. Rajasimha has authored 15 high impact journal publications, 2 book chapters, and inventor on 2 patents. He is a keynote speaker, convener of #DigitalOMICS meetup around the Capital Beltway and other part of several conference organizing committees. Dr. Rajasimha has received numerous Awards for his work in genomics, precision medicine and rare diseases including a travel award to join the NGO Committee on Rare Diseases at the United Nations headquarters, New York City in Feb 2019, Lead India Foundation 2020 Award for leadership and outstanding achievement in rare diseases, NTT DATA Healthcare Life Sciences Silver award for outstanding achievement 2017, Sanofi Genzyme patient advocacy leadership award 2016, Bioscience company of the year 2014, NEI director’s innovation award 2012 for building their genomics cyber infrastructure. Harsha earned his M.S. in Computer Science (2004) and Ph.D. in Genetics, Bioinformatics and Computational Biology (2007) from Virginia Tech.
Session 5: RARE DISEASES AND THE ROLE OF SYSTEMS/NETWORK MEDICINE
DAY 3: September 13, 2019 | Session 5 Co-Chair | 12:00 PM - 12:10 PM
Session 5: RARE DISEASES AND THE ROLE OF SYSTEMS/NETWORK MEDICINE
DAY 3: September 13, 2019 | Session 5 | 10:45 PM - 12:15 PM
Jeeva's AI-Based Virtual Trials Site Accelerates Clinical Trials, Significantly Reduces Cost and Patient Travel Burden
Harsha K. Rajasimha, PhD. Jeeva informatics solutions Inc., Reston, VA, USA
The average cost of trial operations per patient range from $16K in Phase I trials to $26K for phase III. Over 97% of eligible participants don’t enroll primarily because of travel burden. On an average 30% of consented patients drop out during the course of a trial. Most trials operations are outsourced by sponsors to CROs who recruit brick and mortar sites to recruit participants. Orphan drugs take twice as longer to get regulatory approvals compared to non-orphan drugs. “Directors of clinical trial operations complain that every trial seems like the first ever trial conducted by mankind.” A small number of industry sponsored pilot studies demonstrated utility of online internet-based approaches.
Jeeva’s AI-Based virtual trial site helps Investigators and directors of clinical trials operations accelerate speed, saving them significant cost while reducing participants travel burden by up to 80%. Jeeva serves clinical trials operations as a central virtual site to enroll and engage geographically distributed diverse patients from where they live. Sponsors and CROs can include Jeeva as a virtual site in addition to other brick and mortar sites as an option for participants to participate using our smart-phone based technology platform or Jeeva can serve as the only virtual site conducting the trial from eConsent through database lock and study closeout. Jeeva replaces upto 80% of in-person follow up site visits with eVisits. Jeeva’s AI engine learns from past clinical trials to automatically guide the next trial to ensure better operational performance enhancing the overall probability of trial success.