Investigator Initiated Research Submission
Thank you for your interest in partnering with Endologix on your Investigator-Initiated Research. Physician collaboration is central to Endologix’s mission, fueling innovation that transforms patient care.
Please complete the form below and upload the required submission documents (i.e. research synopsis, budget, timelines and milestones, and curriculum vitae and/or medical license).
Each submission is evaluated consistently for educational and scientific merit, potential to improve patient outcomes, compliance with applicable guidelines, and budget availability.
What is Investigator Initiated Research (IIR)
IIR is a research study initiated and conducted by an independent investigator, where the investigator assumes responsibility for the design, conduct, management and regulatory oversight of the study.
Can I submit an IIR request involving an investigational device or devices for off-label indication?
No. Requests involving investigational products or devices for off-label indications are not accepted. Only studies for approved devices and on-label indications will be considered for IIR submissions.
Who can submit an IIR proposal?
Licensed healthcare professionals, clinical researchers, or institutions with experience in conducting research and access to the target patient population may submit a request.
How long is the review and approval process?
We aim to provide a decision on submitted proposals in one to three months, which provides time for collaborative communication.
Who do I contact if there is an issue with my submission or I am not able to use the online submission form?
If there are further questions or issues with the online submission form, please contact Endologix at iir@endologix.com
Are submissions accepted globally for Investigator Initiated Research?
Yes, Investigator Initiated Research requests will be considered from all countries where the product of interest is commercially available.
What criteria are used to evaluate proposals?
Each submission is reviewed for scientific merit and feasibility, investigator qualifications, alignment with company research strategy, budget justification, as well as ethical and regulatory compliance.
What is the IIR review and approval process?
Upon receipt of all required submission documents, the Endologix review committee will review and either approve, deny, or request clarification before making a final decision.
For preliminary ideas, the committee may provide feedback indicating general interest; however, this does not guarantee approval of a full submission.
Can I re-apply if my proposal is declined?
Although denial of an application does not mean that the proposed research lacks value, we highly encourage Investigators to pursue other sources of funding and welcome Investigators to reapply with a new or revised study idea.
What happens after my research is approved?
An agreement is executed between Endologix and the Investigator/Institution, including a budget with payment milestones. The Investigator must comply with all regulatory requirements, report any adverse events, and submit periodic progress reports per the agreement.
Are study results required to be published or disclosed?
We encourage Investigators to publish results in peer-reviewed journals or present at relevant conferences. All publications must comply with applicable transparency and authorship guidelines, as agreed upon in the contract.
Who owns the data generated from an IIR study?
Generally, the Investigator owns the data. Endologix, however, may request access to de-identified data for regulatory or strategic use, as agreed upon in the contract.
What documents are required to be submitted?
Please submit the electronic form and attach all required documents:
- Research synopsis
- Itemized budget: include any resources such as internal and external products, and any alternate funding sources, as applicable.
- Timelines and key milestones
- CV and/or medical license
- Any additional supporting documents: This may include monitoring plan, data management plan, informed consent, record retention, research team contact list, logistical information, laboratory and radiological information, adverse events reporting, publications, etc.