Investigator initiated trials (IIT)

An IIT is a research study where the principal investigator or institution designs and implements the research study and acts as the study sponsor. The study sponsor is the individual (or entity) responsible for complying with all applicable regulatory requirements, guidance, and laws related to the research study. This also includes registering the study with applicable governmental agencies and websites (eg, https://clinicaltrials.gov/) and reporting safety data to all relevant regulatory authorities.

Pacira provides research grant support in the form of product or funding in our therapeutic areas of interest based on the scientific merit of the research study. The research must aim to contribute to the greater scientific community and the budget must be reasonable and appropriate for the proposed research study. In considering applications for IITs, Pacira will consider, among other factors, the expertise of the principal investigator and any co-investigators, including their experience in the relevant therapeutic area, demonstrated ability to successfully conduct clinical trials, and available resources.

The study sponsor (ie, principal investigator) will have full and final discretion and responsibility for all aspects of the study design, implementation, data analysis, and data dissemination, including compliance with all laws and regulations applicable to research sponsors.

Please note that IIT funding is not contingent upon the use, purchase, or recommendations of Pacira products.

The process

Pacira maintains a stepwise process for review of IIT proposals. In brief, after registering on the online grant portal, the principal investigator submits a brief concept proposal and if accepted after review by the Pacira Grant Review Committee (PGRC), will be invited to submit a full proposal.

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