Clinical IIS Overview
NICO Corporation is committed to improved patient and economic outcomes through the continued expansion of valid clinical information supporting those outcomes with the use of minimally disruptive and automated technologies. With this commitment in mind, the company has established an Investigator Initiated Study Program (IIS).
The aim of the program is to provide support for research conducted on novel applications of the use of NICO technologies in clinical practice which lead to improved or significant change to clinical, economic, or operational outcomes. All projects supported by this program are conducted by the applicant(s) and their respective affiliate institution(s). As such, NICO is neither involved in collecting information, in conducting research, or in the publication of any project findings.
Requests for funding may be submitted at any time. Projects are reviewed for scientific merit, feasibility, possible contribution to the respective body of clinical knowledge, and compatibility with NICO’s long-term technological focus. Those requests which are deemed to have substantial merit and scientific potential and are in line with NICO’s technology goals will be considered for funding. It is important that requests clearly describe the objective(s) and scientific importance of the proposed research.
Proposals will be evaluated by committee based on the above for “Preliminary Approval.” If “Preliminary Approval” is granted, a collaboration between the submitting PI and the IIS Review Committee will commence with the goal of “Final Approval” for funding.
For the highest opportunity to receive Preliminary Approval, we recommend:
- Consult the materials available in the IIS Program Resources
- Clearly describe your study objective(s)
- Place emphasis on the clinical or scientific importance of your study
- Follow the instructions to the best of your ability and reach out with questions
When you are ready, sending a proposal to the evaluation committee for the IIS Program is easy! Simply complete the proposal form and email to Clinical_Affairs@niconeuro.com. Currently, only sites in the United States or its territories are eligible to apply.
To help to prepare a successful concept, we are providing the following guidance. Please be aware that this is a highly competitive process with numerous studies approved. It is best to check http://www.clinicaltrials.gov to ensure similar studies are not ongoing.
The program encourages Residents/Fellows to be involved in conducting IIS under the guidance of a mentor. In such cases, please specifically mention, in concept form, the intent of a mentored IIS, include CVs of both the investigator and mentor.
The IIS program does not include any investigational pipeline devices at this time for independent clinical investigations and will not be considered.
The IIS program is under Medical/Clinical Affairs. As such, sales representatives/marketing personnel may not participate in the submission process or receive/accept/forward research proposals or respond to research/IIS questions.
Should you have specific questions about the process or program, please contact us.