FAQs

If you don't see your question here consult the User Guide or email e.warner@kedrion.com

How do I get started?

The first step in applying for research funding from Kedrion Biopharma is to contact a Kedrion Biopharma Medical Science Liaison (MSL), who can guide you through the process of submitting a proposal.

How do I create an account?

To begin a proposal, you will need to create an account via the IIR Portal. You will create a User Name and Password that will grant you secure access to the IIR Portal. If you have forgotten your password, you can reset it by clicking the “Forgot Password” link. After creating an account, you will be able to log in and out, and save your work to come back to it later.

What types of research proposals are eligible for support?

IIR funding is available to provide product and/or financial support for Phase 4 studies involving Kedrion Biopharma’s products approved for use in the US. Kedrion Biopharma will evaluate funding requests based on scientific merit and alignment with the following strategic interests:

  • Hemophilia

  • Other Bleeding Disorders
  • Immunology
  • Hyperimmune Globulin Therapy
  • Neurology
  • Critical Care

To request product and/or funding for in vitro or in vivo animal studies, please contact Kedrion Biopharma Medical Affairs.

What is the difference between a Concept Proposal and a Full Research Proposal?

A Concept Proposal is an initial, brief description of the proposed study that provides enough information for Kedrion Biopharma to determine whether a request for a Full Research Proposal is warranted. Concept Proposals are submitted via the IIR Portal.

 

If your Concept Proposal is of interest to Kedrion Biopharma, you will be invited to submit a Full Research Proposal, submitted via the IIR Portal. The Full Research Proposal requires a full study protocol and detailed budget.

 

Information you’ll need to complete and submit each proposal is outlined in Table 1.

 Concept ProposalFull Research Proposal
General Information

  • Principal Investigator contact information

  • Sponsor curriculum vitae

  • Institution Information

  • Medical/Nursing license number of principal investigator


  • Study team roster, including:

    • Names and contact information

    • Curricula vitae

    • Medical/nursing license numbers

    • Role in study



  • List of participating study sites

Study Design

  • Title of study

  • Study type

  • Research Setting

  • Therapeutic area

  • Rationale and objectives

  • Anticipated study duration


  • Full protocol title

  • Study objectives

  • Background and rationale, including needs assessment

  • Full study design, including

    • Participant selection/ enrollment

    • Inclusion and exclusion criteria

    • Study intervention, including administration, dosing and duration

    • Milestone timeline

    • Study procedures, including:

      • Assessments at screening, follow-up and final visits

      • Safety assessments

      • AE reporting procedures


    • Description of independent monitoring committee

    • Statistical hypothesis and sample size calculation

    • Primary and secondary outcome measures

    • Data collection procedures

    • Quality assurance measures

    • Forms:

      • Informed consent form

      • Case report form (CRF)

      • Safety reporting form



Budget

  • Type of funding requested (product and/or study funding)

  • Estimation of total study cost

    Full itemized budget, including:

    • Institutional overhead

    • Quantity of study drug requested

    • Personnel costs

    • Labs and procedural costs

    • IRB fees

    How do I know if my proposal has been received?

    Kedrion Biopharma will acknowledge receipt of all completed submissions via email.

    When and how will I receive notification of the outcome of the review?

    All proposals will be reviewed by the Kedrion Biopharma IIR Review committee. Funding decisions will be based upon scientific merit, quality of study design, alignment with Kedrion’s strategic interests and the amount of funding requested. Sponsors will be notified of the outcomes of all proposal reviews.

     

    For a Concept Proposal, you will be notified of the outcome of the review within 14 days. If your proposal is of interest to Kedrion Biopharma you will be asked to submit a Full Research Proposal. You will receive formal notification of award of funding for a Full Research Proposal when a decision is reached.

    Can I complete part of the online application and come back to it later?

    Yes – proposals do not need to be completed in one sitting. You can save your work on the portal prior to logging out and come back to it at a later time.

    How long does it take to execute a study agreement if I’ve been awarded a grant?

    This depends on the contracting process for each institution. Kedrion Biopharma will develop a contract which will be sent back to the investigator. It is the investigator’s responsibility to deliver the contract to all interested parties at their institution for review. The length of time the process takes will be dependent on both parties arriving at acceptable terms for the study agreement.

    What is included in a study agreement?

    The study agreement with Kedrion Biopharma will include, but not be limited to the following provisions:

    • To comply with applicable federal and local statutes and regulations, including but not limited to those regarding the protection of human subjects
    • That no investigator or other study personnel has ever been subject to a disqualification or debarment action by the FDA and/or other applicable regulatory body
    • To meet all agreed-upon timelines and deliverables and to provide agreed-upon study updates
    • To deliver a final written report of study results to Kedrion Biopharma
    • To allow Kedrion Biopharma to review any abstract or article resulting from the study prior to public release

    What are the expectations regarding publishing study results?

    Sponsors must agree to allow Kedrion to review any abstract, presentation or article resulting from the study prior to its public release. Kedrion Biopharma support of the study must be fully disclosed in any publication or presentation of study results.

    My institution has established indirect costs higher than 25% - will my proposal be funded?

    Kedrion Biopharma limits indirect costs to 25% of the total award. We are, unfortunately, unable to fund proposals with indirect costs exceeding that percentage.