Investigator Initiated Research Grants
Paladin Labs is committed to advancing medical and scientific knowledge about our therapies for improving patient care through support of Investigator Initiated Research (IIR) Grants.
This program is open to all Canadian physicians, researchers and institutions who are interested in conducting their own clinical and basic science studies that address important medical and scientific questions related to our products and research area of interest.
Paladin may provide support in the form of study drug and/or financial support in response to unsolicited research proposals that meet our standards of quality and compliance. IIR is conducted independent of Paladin. The Investigator or the institution (academic, private, or government) serves as the Sponsor of the research and is responsible for study conception, design, conduct, data handling, data analysis/interpretation, subsequent reporting/publication and ensuring compliance with all legal and regulatory responsibilities of the studies as defined by all applicable laws and regulations. Paladin accepts submission for both clinical (interventional and observational) and preclinical studies (in vitro and animal).
These grant proposals are reviewed by a committee of Paladin’s medical and scientific personnel. Decisions for support are strictly based on scientific merit, feasibility, safety, legal and ethical considerations, alignment with Paladin’s research area of interest and availability of resources and funds. Paladin support for any Independent IIR Grants in no way implies any obligation toward, and is not in any way connected to, the recommendation or prescribing of Paladin products.
Paladin may provide support in the form of funding, study drug or both. All proposals must be unsolicited, original research, which complements, and does not duplicate or conflict with Paladin’s ongoing research and development plan.
Current Main Therapeutic Area of Interest
- Transplant (kidney and liver)
- Movement Disorders
- Serious bacterial skin and skin structure infections
The Paladin Investigator Initiated Research program is open to all Canadian healthcare professionals, researchers and institutions. In order to ensure adequate review, proposals must be received at least 120 calendar days prior to the anticipated start of the study. No proposal can be submitted past the initiation of the study.
Paladin accepts brief concept submissions to gauge Paladin’s interest in the proposed research, or full study proposal submission. If a concept submission is submitted and is of interest to Paladin, the Investigator will be invited to submit a full study proposal with a complete study protocol for further review and consideration. An interest in the concept proposal does not guarantee approval of the subsequent full study submission.
To submit a concept or full study proposal:
- Go to www.endorequests.com
- Select Canada
- Select IIR
- Sign up for an account and follow the steps
Please complete all mandatory fields and ensure that the information requested is included in your submission. Additional documents (eg, protocol) can be uploaded into the IIR portal.
Paladin will acknowledge receipt of all submissions. The proposals are reviewed by a committee of Paladin’s medical and scientific personnel on a regular basis. A formal notification on the status of an application will be sent once a decision is reached. Time for review will depend on completeness of the submission. Paladin makes no guarantee that it will approve all requests received via the portal. Paladin support for any Independent IIR Grant in no way implies any obligation toward and is not in any way connected to the recommendation or prescribing of Paladin products.
Budget and Overhead Costs:
- A detailed budget must be submitted with the Full Submission.
- An itemized budget detailing study related expenses that are commensurate with fair market value is required for review of the Full Submission.
- Reasonable direct study cost. Paladin will only pay reasonable overhead for total direct study costs.
- Indirect study costs should be applicable to study (e.g. IRB review fees, equipment expenses). (Overhead will not be paid on indirect study costs.)
- Paladin will not support cost for IIR that has already been completed or activities not related to the IIR.
Paladin Requirements Before Initiation of IIR Study:
After approval to fund a full submission, there are several documents that Paladin requires before it can initiate support (drug and/or funding). Paladin requires the following:
- Fully executed IIR agreement which outlines all contractual obligations of Paladin and Investigator
- Institutional Review Board (IRB)/Ethics Committee (EC) Approval Documentation (IRB/EC approval letter, IRB/EC approved study protocol and IRB/EC approved informed consent form, (as applicable) or IRB/EC waiver documentation
- Documentation of Clinical Trials Application (CTA), if applicable
- Institutional Animal Care and Use Committee (IACUC) approval (applicable to animal studies)
- Final IRB-approved study protocol
- Registration on ClinicalTrials.gov or other clinical trial database, as applicable
No product or funds will be sent to any institution until receipt by Paladin of all executed requested documents.