Investigator-Initiated Studies

Guidelines for Submission

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.

Types of IIS eligible for support:
  • 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
The sponsor/investigator has to agree to fulfill the following requirements:
  • have the scientific, technical, and operational capabilities to conduct a study as a sponsor including adequately trained staff to execute a study (GCP, GMP, etc.)
  • have expert statistical support
  • submit a scientifically well designed and well-written study proposal
  • deliver to agreed timelines
  • be able to fulfill all regulatory requirements (including submitting an IND/CTA, writing of final study report, and manuscripts, etc.)
  • deliver a written report of the final study results to CooperSurgical
  • submit manuscript for publication in a scientific journal
  • agree to safety reporting to health authorities and to CooperSurgical
  • agree to provide study updates to CooperSurgical
How to Apply for IIS Support

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:

  • A fully-executed IIS agreement between the sponsor and CooperSurgicalSurgical
  • A fully-executed IIS safety data exchange agreement between the sponsor and CooperSurgicalSurgical
  • An IEC/IRB approval and health authority approval, as appropriate All funding requests will be assessed to ensure that they do not exceed local fair market value. Funding requests for expenses not associated with the conduct of the study are strictly prohibited.