Disrupting Clinical Trials by Innovator Dr. Harsha Rajasimha of Jeeva
Disruption Interruption podcast host and veteran communications disruptor, Karla Jo Helms, interviews Dr. Harsha Rajasimha, Founder & CEO of Jeeva Informatics Solutions — and uncovers how he has utilized his experiences and education to bring disruption into the pharmaceutical and healthcare industry by listening to all stakeholders involved in the process of clinical trials.
Today there are approximately 7,000 rare diseases affecting about 350 million worldwide.(1) That is more than the entire population of the United States. Many of these diseases have no treatments. However, clinical drug and treatment trials stand to prevent much of the immense suffering and death. These trials typically take 5 to 7 years to complete and get a drug or vaccine to market. In contrast, COVID-19 vaccines were developed in a fraction of the usual time — in 5 to 7 months. Enter Disruptor Dr. Harsha Rajasimha, Founder & CEO of Jeeva Informatics Solutions — who explains to Karla Jo Helms, host of the Disruption Interruption podcast — that if we applied the COVID-19 trial’s timeline to other diseases, many more vaccines and drugs for even rare diseases could begin helping millions who are now suffering. But right now, 88% of drugs that enter into human clinical trials do not get FDA approval because of the lack of evidence, enrollment difficulties, and patient retention.
After losing a child to a rare disease, Dr. Rajasimha and the lack of an early diagnosis that could have been detected at the first trimester, Dr. Rajasimha said, THAT’S IT — I’M DONE WITH THE STATUS QUO — and quit his FDA consulting job, resolving to solve the early diagnosis problem — that much of the delays in trials could be solved via software technology — but that using EMPATHY when approaching patients was essential for bringing in and retaining qualified patients for clinical trials.
Dr. Rajasimha then made it his mission to develop a software as a service solution (SaaS) that brings the thousands of stakeholders into the same space to streamline redundant processes to shorten the timelines to drug and vaccine development and redirect resources to further advancements.
Dr. Rajasimha reveals how:
- Money isn’t the barrier prohibiting drugs from coming to market — rather it is finding those who fit the criteria along with their enrollment process and retention.
- The biggest problem with clinical trials is the failure to identify the right patient, having them understand and enroll in the trial, and their ability to comply, whether it be due to lack of technology and other logistical problems they encounter.
- His company is overcoming researchers’ barriers to collecting accurate data, “white coat” and “parking lot” syndrome with patients are among the logistical problems illustrating the human side of clinical trial skewing results
- Jeeva’s software solution centralizes and simplifies the clinical trial processes but also incorporates empathy for patients within the trial to accelerate their recruitment and retention.
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About Jeeva Informatics:
Jeeva Informatics Solutions, Inc., based out of Tysons Corner, VA, partners with Biopharmaceutical sponsors, CROs, and clinical researchers to accelerate clinical studies. The Jeeva TRIALMAGNET(TM) package of the patent pending Jeeva eClinical Cloud platform achieves remote patient recruitment goals by as much as three times faster. Jeeva’s flexible bring-your-own-device (BYOD) SaaS solution works on any browser-enabled mobile device and saves more than 70% time by minimizing the logistical burden on study teams and patients. Modular software design allows a rapid study configuration with the features and workflows that fit the specific trial protocol whether short-term or long-term, cross-sectional or longitudinal, interventional or observational studies, clinical phase or post-market, hybrid or fully remote. To learn more, visit jeevatrials.com.
- Ornskov, Flemming. “350 million people suffer from rare diseases. Here’s how tech can help.” World Economic Forum, 19 January 2018, weforum.org/agenda/2018/01/350-million-people-suffer-from-rare-diseases-heres-how-tech-can-help/.
And lastly, if you’re a disruptor…
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