Investigator Initiated Study (IIS)
Purpose and Objective of Program
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 evaluate existing retrospective data or conduct prospective high quality studies with the goal of manuscript submission for publication. Selected investigators may be provided financial support, accordingly. 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 support may be submitted at any time. Requests are reviewed for scientific merit, feasibility, possible contribution to the respective body of clinical knowledge, and compatibility with NICO’s long-term clinical and scientific focus. Requests deemed to have substantial merit and scientific potential, and are in line with NICO’s clinical and scientific goals will be considered. Only sites in the United States or its territories are eligible to apply.
First, a potential investigator should submit a complete Proposal (Concept) Summary and Proposed Budget. Upon submission of these proposals, a formal review by NICO Clinical Affairs will be conducted to determine if preliminary approval may be granted. The typical review turnaround time is 1-2 months from receipt of the request to investigator notification of preliminary approval. It is important that requests clearly describe the objective(s) and clinical or scientific importance of the proposal.
If preliminary approval is granted, a protocol is requested for submission. Final approval may be granted only upon review of a Completed Protocol and Detailed Budget.
Potential investigators must closely follow instructions in the submission of either the Proposal Summary or Complete Protocol (instructions for Complete Protocol to be provided upon preliminary approval).
Submitting a Proposal (Concept) Summary
- Complete PARTS I and II of the application materials:
- PART I: Proposal Summary
- PART II: Proposed Budget
- Submit the following materials electronically:
- Completed PART I: Proposal Summary
- Completed PART II: Proposed Budget
- Principal Investigator (PI) – Curriculum Vitae
- If Resident/Fellow acts as investigator, include CV of both investigator and mentor with detailed letter from mentor describing how research will meet career goals of submitting Resident/Fellow
If you have specific questions about the process or program, please contact Clinical_Affairs@niconeuro.com.