General Information
Eligibility
- Eligible Recipients or Providers: Hospitals, medical centers, medical schools and their affiliated foundations. Government departments and agencies that are authorized to receive funds for research
- All Leadiant IITs will be reviewed and approved only if they are in full compliance with all applicable laws and regulations, including but not limited to the Anti-Kickback laws, FDA regulations, State and Federal reporting and disclosure laws, as well as OIG Guidance and the PhRMA Code
- The Leadiant IIT Committee (IITC) reviews an Investigators IIT Concept submitted by the Investigator, and awards funding or product based on objective merit and conformity with the criteria established by this policy
- The Leadiant IITC is comprised of one designated individual from each of the following departments: Legal Department, Regulatory Affairs, and Medical Affairs
Funding Guidelines
- Funding may not be provided in order to influence the use or prescribing of Leadiant products, or in order to obtain a recommendation, through inclusion in a formulary or otherwise, for the use of Leadiant Biosciences products
- Funding may not be given with the express or implied understanding that the recipient will favor, recommend, prescribe or use Leadiant products or services
- Funding may not be given with the express or implied understanding that the activity or arrangement funded will provide incentives for recipients to use or prescribe Leadiant products or services
- Funding may not be given to reward recipients for past loyalty to Leadiant products
- Funding may be reportable under the Sunshine Act. For more information, please email IITs@leadiant.com
Submission Requirements
The Investigator is held to the same standards and obligations as any other individual or organization that takes responsibility for and initiates a clinical investigation. These responsibilities include :
- Writing the protocol
- Writing the Case report Form
- Monitoring the study and reviewing the source documents
- Drug accountability
- Submitting safety reports to the FDA
- Registration on a recognized clinical trials registry (e.g. clinicaltrials.gov)
- Submitting an acceptable IND
- Complying with all applicable laws and regulations
FAQs
IIT Review Process :
- No Leadiant employee can commit Leadiant to funding an IIT grant or sign any agreement before a grant is fully processed and approved through the Leadiant IIT Committee. All IIT grants, regardless of dollar amount, must be presented to the IIT Committee
- Grants are only provided to IITs approved by the IIT Committee
- Leadiant Biosciences requires a signed contract before any approved funding is provided