The Investigator Initiated Study (IIS) Program is an important part of Cynosure’s complete program of Medical Aesthetic research. Combined with our own comprehensive Translational, Development and Post Market Research program, the IIS Program aims to ensure the highest standard of innovation to give providers maximum growth and opportunity while providing patients with cutting edge treatments, services and results they deserve.
The IIS Program is a pivotal connection between Cynosure and external researchers to expand research.
Cynosure provides support for research that advances medical aesthetic treatment and scientific knowledge about our products. This global program is open to all qualified researchers who are interested in conducting research of value to Cynosure as determined by the Scientific Grant Committee.
Investigators can submit study ideas as a concept using the Submit a Grant Request button.
A concept or study idea includes a short, high-level summary of the study’s Main Scientific Question including therapeutic area, application of product or protocol, an estimated budget and research design setting details. A full proposal submission will still be required if the concept is approved. The template form for this is found online by pressing the ‘Submit a Grant Request’ button.
With this information, the Strategic Alliance Team will determine whether or not Cynosure would like to explore the proposed study idea and have the Scientific Grant Committee review the submission. If so, additional information may be required for a proposal submission before funding can be considered and a final decision made.
This additional information may include a full proposal submission, detailing the study, including a line item budget and a fully developed protocol with objectives, designs, procedures, analysis plan, adverse event reporting, and safety plan as needed.
With this information, the Research Committee will determine whether or not Cynosure would like to explore the proposed study idea.
*Please note that submission of a study concept grant request does not imply or guarantee approval of the grant.
Cynosures Scientific Grant Committee meets once a month to review projects determined to be of interest to Cynosure, the medical aesthetic community and their patients.
Decisions will be made based on scientific strength and impact on Cynosures overall research strategy. These decisions will be made objectively as to avoid all unlawful inducements to Health Care Professionals without commercial influence. Review of the application may result in the grant being fully approved, approved with conditions, request for further information, deferred until a later date, or declined.
If funding is approved, a research agreement will be drawn up between Cynosure and the Investigator’s Institution.
The research agreement protects physicians, patients and Cynosure by defining roles and expectations. It addresses issues such as level of patient/study risk, understanding the requirements of a sponsor-investigator, intellectual property ownership and publication. It documents the final protocol and milestones so that support can be provided when it is needed as the steps are completed.
In the event there are submissions that may need additional regulatory approvals, it will be the Sponsor’s or researcher’s responsibility to obtain approval from appropriate regulatory bodies.
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