Research Opportunities
Learn more about our research engagements and how to apply.
Program Overview
Investigator-Initiated Studies (IIS)
CooperSurgical is committed to supporting Investigator-Initiated Studies (IIS) that seek to advance medical and scientific knowledge, facilitate diagnosis, and improve clinical outcomes or the standard of care. Such clinical studies can play a crucial role in answering important questions regarding CooperSurgical’s products and their related therapeutic areas.
IIS are conceived, initiated, and conducted by an independent investigator who has complete responsibility to conduct and administer the research program. CooperSurgical may support IIS with product supply, material, or information, as allowed under local laws and regulations, provided that they align with the CooperSurgical-defined areas of strategic interest.
Please note that CooperSurgical is currently providing limited monetary support for IIS.
Types of Eligible IIS
- Clinical studies of approved and investigational uses, involving marketed CooperSurgical products or those still in development
- Clinical observational studies
- Outcomes research studies on patient population outcomes or pharmacoeconomics
Research Areas of Interest
CooperSurgical supports research that addresses healthcare topics and patient care needs adequately aligned with our current medical, educational, and scientific areas of interest. For more information on our current research areas of interest, please contact us at [email protected].
Submission Process
Overview of the Application Process
CooperSurgical welcomes unsolicited concept proposals for Investigator-Initiated Studies (IIS) that meet eligibility requirements and align with our research areas of interest. The Research Application can be accessed electronically here, or a paper copy can be obtained by emailing [email protected].
Concept submission will be reviewed collectively by the CooperSurgical IIS Committee, and support will be awarded based on the study’s scientific merit, its alignment with our research areas of interest, as well as available resources and research priorities. Please allow at least 60 days for review of concept proposals after the completed application is received.
Should CooperSurgical be interested in the concept submission, the investigator will be contacted and invited to submit further details and a final protocol in order to be considered for full approval.
Please note that CooperSurgical is currently providing limited monetary support for IIS.
Eligibility Criteria
The sponsoring investigator/institution must agree to fulfill the following requirements:
- Obtain IRB approval of the protocol and informed consent form, as applicable, and provide CooperSurgical with documentation of such approval
- Design, conduct, and complete the proposed research after consulting the Good Clinical Practices guidelines, when applicable
- Fulfill all regulatory requirements (including submitting an IND/CTA, writing of final study report, and manuscripts, etc.)
- Submit periodic progress reports and a final report to CooperSurgical
- Submit the protocol to the IRB/ethics committee for review, if applicable
- Register the study, if appropriate, on a web-based clinical trial registry
- Publish results of the study through posters, presentations, or papers at a relevant congress
Submitting a proposal
The IIS application requires the sponsoring investigator/institution’s information as well as details pertaining to the research proposal itself. This includes, but is not limited to, a brief protocol summary, description of the study design and duration, its overall objectives and outcome measures, evaluation methods for those objectives, and the type of support requested.
The following documents are needed in order to complete your application:
- Cover letter on letterhead of organization including a summary of the project to be funded
- The identity and location of the institution(s) at which the research will be conducted and to which any funding or product will be sent
- Itemized budget or other breakdown describing the proposed use of the funds or product
- The Principal Investigator’s CV
- The IRB application (if applicable)
Please note that submitting a proposal does not guarantee you and/or your organization will receive approval.
Proposal Review
CooperSurgical considers a variety of factors when making decisions concerning research support. Concept submission will be reviewed collectively by the CooperSurgical IIS Committee, and support will be awarded based on the study’s scientific merit, its alignment with our research areas of interest, maintenance of product integrity and use as stated in the study protocol, and funding availability. The decision to support an IIS is not influenced by Sales and Marketing in any way.
Following review of the initial concept proposal, the requester will be informed about the committee’s decision on whether research support has been approved. In some cases, we may reach out to you for clarifications before reaching a decision.
Please allow at least 60 days for review of concept proposals after the completed application is received.
IIS Agreement
If support for the study is approved, an Investigator-Initiated Study (IIS) Agreement will be coordinated between CooperSurgical and the investigator or institution that employs the investigator. It is a written, dated, and fully executed contract that details any arrangements on delegation and distribution of tasks, certain obligations including financial performance and reporting, and ownership of intellectual property of both parties.
Financial Disclosure
CooperSurgical support for IIS conducted in the United States must be reported to the U.S. government as required by the U.S. Physician Payment Sunshine Act. The Sunshine Act requires all medical device manufacturers to track and report payments and transfers of value to U.S.-licensed physicians and teaching hospitals.
FAQs
CooperSurgical may provide support in the form of supply of a drug or medical device product. We are currently providing limited monetary support for studies.
In an IIS, research is conceptualized, initiated, and conducted by an Investigator who has complete responsibility to conduct and administer the research program. The Investigator or the institution that employs him or her serves as the Sponsor of the research program and is responsible for complying with all legal and regulatory obligations related to the conduct and management of the study.
CooperSurgical is never the Sponsor of an IIS.
CooperSurgical will not support the following:
- Requests for support for ongoing or new research without an associated study protocol or synopsis.
- General education and training activities.
- Support for ongoing clinical programs that are part of an organization’s routine operations.
- Start-up funds to establish new clinical or research programs or to expand existing programs.
- Purchases of capital equipment unrelated to the study or that would generate revenue.
- Construction funds to build new facilities.
- Hiring of staff that are not dedicated to the study.
- Please note that CooperSurgical is currently providing limited monetary support for IIS.
Researchers are invited to request an application by contacting [email protected].
The IIS application requires the sponsoring investigator/institution’s information as well as details pertaining to the research proposal itself. This includes, but is not limited to, a brief protocol summary, description of the study design and duration, it’s overall objectives and outcome measures, evaluation methods for those objectives, and the type of support requested.
Applications are accepted and approved at any time throughout the year. Review times may vary but please allow at least 60 days for review of concept proposals after the completed application is received.
In order for the study to receive study product, CooperSurgical must receive the following items:
- The fully executed IIS Agreement
- Institutional Review Board (IRB) Letter of Approval or IRB
- Letter of Exemption with Expiration Date (Stamped Version or confirmation from institution that documents are not stamped)
- IRB Approval Protocol (Stamped Version or confirmation from institution that documents are not stamped)
- IRB Approved Informed Consent Form (ICF) (Stamped Version or confirmation from institution that documents are not stamped) (Not applicable to all studies)
Yes, please email [email protected] for more information regarding our current research areas of interest.
No, each proposal is evaluated on an individual basis. Concept submission will be reviewed collectively by the CooperSurgical IIS Committee and support will be awarded based on the study’s scientific merit, as well as available resources and research priorities.
Yes, investigators and institutions conducting clinical IIS in humans, supported by CooperSurgical, should report the research and all results on a clinical trial website such as ClinicalTrials.gov, if applicable. The responsibility to register the study on this database sits with the Investigator and his/her institution.
The investigator is responsible for reporting study-related adverse events and following all applicable CooperSurgical, governmental, and institutional Pharmacovigilance Reporting procedures. Failure to comply with adverse event reporting procedures and regulations could be grounds for terminating the IIS.
Upon notification from the investigator that the IIS has been completed, CooperSurgical begins the IIS Completion process. This process includes:
- Review of the IRB Study Close-Out Notice from the investigator.
- Notification to all applicable parties that the IIS is completed.
- The IIS Completion Letter is sent to the investigator reminding them of their obligations per the IIS Agreement.
- This includes providing a copy of the final study report and/or draft manuscript, publishing and posting of results, and notifying all applicable parties of study completion.
- Review of Final Study Report (e.g. manuscript suitable for submission to a peer-reviewed journal) from the investigator.
Yes, the Sunshine Act requires all medical device manufacturers to track and report payments and transfers of value to U.S.-licensed physicians and teaching hospitals. In-kind devices will be reported at Fair Market Value.
Please reach out via email to [email protected] with any additional questions.
Submit a Proposal
After reading the Submission Process, click on the link below to submit your proposal.
Ask a Question
If you still have questions after reading over the Frequently Asked Questions (FAQs), please reach out to us by emailing [email protected].
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