An Investigator-Sponsored Study (ISS) or Investigator Initiated Study (IIS) is an unsolicited preclinical, clinical, outcomes or disease-state study.
In an ISS/IIS, an investigator independently generates a research proposal, and if approved Inceptua provides support for the proposal. 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, 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 analysing and communicating all study results.
Inceptua recognises the important role that ISSs can play in expanding the knowledge related to Inceptua’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.
Proposals will be reviewed by an ISS/ IIS Committee consisting of personnel from medical affairs and safety.
In order to be approved for support by the ISS/ IIS Committee, a study must meet certain criteria.
In addition to the scientific evaluation, the ISS/ IIS Committee will ensure that requested funds are justified, reasonable and commensurate with fair market value, and that submitting investigators are eligible to conduct the proposed research. Inceptua will not compensate for educational and training activities, purchase of equipment related or unrelated to the study or which could generate revenue to the Sponsor and staff that are not dedicated to the study.
Investigators must submit a detailed proposal supported by pre-clinical or clinical data with strong scientific rationale and/or an appropriate review of the literature. An up-to-date CV of the investigator as well as a detailed budget breakdown must be submitted together with the application. An ISS/ IIS form will be sent out to the Investigator after initial contact with further details to complete.
Once a proposal is reviewed and approved, the investigator will be invited to submit a full protocol for review to ensure consistency with the submitted study application. Please note, approval of a proposal does not imply or guarantee approval of a full protocol. For final sign-off of clinical studies, a copy of the ethical approval must be provided, when applicable. Any support approved by Inceptua is initiated only upon a fully executed contract and with all necessary documentation in place.