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Investigator Initiated Studies (IISs)

Cerapedics may provide support for studies that can generate important information about Cerapedics products as well as valuable medical and scientific information that may lead to improvements in clinical care, the development of new diagnostics, value-based care, and better delivery of healthcare to patients.


Cerapedics may provide support for an IIS through a grant of funding, product, or both.

Thank you for your interest in submitting an IIS application. It is recognized that the documentation required to fully satisfy the grants review process may be burdensome. Therefore, the Sponsor-Investigator may submit a request in two parts, with the second part conditional on continued Cerapedics’ interest in the planned study. The full grant request may also be submitted without an initial grant request.


Initial Grant Request: A synopsis of the planned study including patients sample size, enrolment criteria, study end points and planned analysis together with the extent of financial support (including study product needs if applicable.)


Once submitted, the application is reviewed for completeness. Beyond any requests for clarification of the request, Cerapedics will indicate whether there is continued interest subject to review of the full grant request within 30 days of receipt.

Below are the simple steps in applying:
Step 1: Register for the Cerapedics Grant Portal using the link at the bottom of the page.
Step 2: Complete and submit the initial application using the Cerapedics IIS RFP application in the portal. You can save your progress and log back in to finish if necessary.
Step 3: Complete Full Grant Request – Contingent on Cerapedics interest in the planned study.


Full Grant Request:

  • Scientific rationale
  • Scope of the study
  • Objective of the study (including whether the product will be used On-Label or Off-Label)
  • Primary efficacy and safety measures
  • Methodology, including patient selection criteria, study design, sample size justification, dosing (if applicable), and a data analysis plan
  • Analysis and Data Reporting Plan
  • Information to study patients (prospective studies only)
  • Declaration that the SI has patients’ consent for processing their personal health data for commercially funded research purposes or intent to seek a waiver for such consent from an appropriately constituted Investigational Review Board (IRB)/EC (retrospective studies only)
  • Nature and amount of the support requested
  • Projected timeline for conduct and reporting
  • Curriculum Vitea for all investigators

Investigator-Initiated Studies (IIS) Review Qualifications

We mindfully review all IIS study requests with a detailed assessment by a cross-functional team that composes the Cerapedics Grant Committee.
IIS requests will be assessed with the following criteria:

  • Scientific Merit and Feasibility
  • Consistency with Company Strategy
  • Compliance with Applicable Laws and Standards
  • Independence
  • Qualified Sponsor-Investigator
  • Reasonableness of Study Budget
  • Restricted Grants

Support for IISs may take one of the following forms, in order of preference:

  • Provision of in-kind product only
  • Provision of in-kind product, plus financial support
  • Financial support


With the provision of support, the Company must not incur the obligations of a Sponsor-Investigator and requested and approved financial support must correspond to an itemized budget. Any financial support must be provided for permissible actual study costs and must be linked to study progress (milestones).

Any Company product will be provided free of charge, where appropriate for the study, and in quantities consistent with the scope of the study.


An IIS grant may include funding for publication costs, including manuscript preparation, if these items are specifically documented
in the governing agreement and associated project budget.

Investigator-Initiated Studies (IIS) - Responsibilities as the Sponsor

Responsibilities of the Sponsor-Investigator:

  • Compliance and Regulatory Requirements: The Sponsor-Investigator is responsible for all required regulatory reporting associated with the IIS.
  • Ethics Committee Approval: For all IISs, Ethics Committee approval must be obtained as required by local laws and regulators.
  • Informed Consent: The Sponsor-Investigator is responsible for obtaining valid informed consent in writing from all human participants in the IIS.
  • Monitoring: The Sponsor-Investigator is responsible for monitoring the study site9s) according to local laws and regulations.
  • Adverse Event Reporting to the Company: For all On-Label IISs, the Sponsor-Investigator is responsible for reporting to the company all suspected (i.e., reasonable possibility of causality) Adverse Events. For Off-Label IISs, the Sponsor-Investigator is responsible for reporting to the Company all Adverse Events, regardless of causality.
  • Publication or Presentation: For all IISs, the Company expects the Sponsor-Investigator to prepare final work product in the form of a written report, manuscript, or abstract of the final study results.