Investigator-initiated studies (IIS) can play a crucial role in answering important medical and scientific questions regarding CooperSurgicalSurgical’s products and their related therapeutic areas. Such clinical studies can contribute towards enhancing the understanding of CooperSurgicalSurgical’s products and their appropriate application, thus improving patient care, and sparking new ideas for further disease-related research aimed at creating an improved treatment for patients.
IIS are independent projects in preclinical, clinical, or observational settings in which clinical studies are initiated and managed by individual investigators, institutions, collaborative study groups, or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations. CooperSurgical may support IIS with product supply, funding, material, or information, as allowed under local laws and regulations, provided that they align with the CooperSurgical-defined areas of strategic interest.
Researchers are invited to submit their concept proposal to IIS@coopersurgical.com. Concept submission will be reviewed collectively by the CooperSurgical Review Committee based on scientific merit and alignment with corporate research and development plans. Please allow at least 60 days for full review of concept proposals.
The requester will be informed about the outcome and 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.
CooperSurgical requires that the following documents are in place before the support can be initiated: