The FDA and National Center for Advanced Translational Sciences, NIH have been encouraging Patient groups to drive the setup of high quality institutional review board (IRB) approved patient registry and disease natural history studies. High quality patient databases are critical pre-requisites for sponsored drug development programs. Jeeva SaaS platform can enable you to capture and aggregate high-quality patient level data over a period of 5, 10, or 15 years, in a cost-effective manner.
Cell and Gene therapies are the most advanced form of one-and-done treatments for patients with rare genetic diseases including Cancers. US FDA guidelines in January 2020 require sponsors of such therapy trials to monitor patients over extended periods of time to better understand the durability of these treatments. A majority of the existing clinical trial management or electronic data capture tools were designed for traditional brick and mortar clinical trials that usually span under 3-year duration. Our purpose designed solution for 5, 10, or 15-year long-term follow up studies is just what you might be looking for.
Investigator initiated single site studies suffer from lack of funding scale necessary to conduct certain large scale real world evidence or observational or drug repurposing studies of safety proven medicines. Jeeva SaaS platform offers a cost-effective solution to quickly setup and conduct clinical studies of any scale or duration with or without patients' travel involved.