An Investigator Sponsored Study (ISS) is an unsolicited preclinical, clinical, outcomes or disease-state study. An investigator independently generates a research proposal, and Sobi provides support for the proposal if approved. Support can include but is not limited to drug material, expert advice, funding to pay for expenses directly related to the research based on fair market value, statistical advice, analytical services, or a combination of these items. The investigator, or the institution the investigator is affiliated with, serves as the study sponsor. As such, the sponsor assumes responsibility for initiating and conducting the study, directing the administration of study drug (if applicable), ensuring compliance with all local laws and regulatory requirements, and analyzing and communicating of all study results.
Sobi recognizes the important role that ISSs can play in expanding the knowledge related to Sobi’s products and their associated disease areas. This research can advance science and contribute to the development of better medicines for patients consistent with the company’s overall research and global development strategies.