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Welcome to the External Research Program for Investigator-Initiated Studies
Overview About the External Research Program Investigator-Initiated Studies Areas of Research Interest IIS Submission Process Frequently Asked Questions
The 2021 submission window for External Research proposals is open. Areas of research interest are updated. Please email questions to ERP@terumobct.com.

Overview

Thank you for your interest in working with Terumo Blood and Cell Technologies External Research Program (ERP). Terumo Blood and Cell Technologies is committed to the advancement of healthcare worldwide by supporting studies in relevant research areas of interest, developed and sponsored by independent investigators or non-commercial sponsors around the globe. An investigator-initiated study (IIS) may be a clinical or nonclinical study conducted without the participation of Terumo Blood and Cell Technologies.


All submissions will be reviewed based on scientific merit, patient or donor safety, strategic alignment, degree of new scientific and clinical evidence, and fair market value. Terumo Blood and Cell Technologies receives many requests for support of research studies. While all submissions will be evaluated, not all submissions can be supported.


For an IIS, the researcher functions both as the sponsor and investigator for the study and is responsible for study conception, design and operational execution; data handling, analysis and interpretation; subsequent reporting and publication; and compliance with all local laws and regulations.


Initial Proposal Application
  • Required supporting documents in English
      • Principal investigator’s curriculum vitae
      • Project summary to include:
        • Background
        • Objective and rationale
        • Primary endpoints
        • Project duration
      • Requested support
        • Materials (e.g., disposable sets/kits)
        • Equipment loans
        • Monetary (in U.S. dollars)

Other Opportunities



About the External Research Program

Terumo Blood and Cell Technologies has established an internal, cross-functional review process when considering support for external research studies. The External Research Committee evaluates all submissions.

Terumo Blood and Cell Technologies will consider support of external clinical research with investigators who are able to demonstrate clear evidence of high ethical and scientific standards as they relate to clinical research in human subjects as stipulated by the International Council for Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP).

Investigators undertaking nonclinical studies must provide evidence of adherence to established processes and laboratory procedures.



Investigator-Initiated Studies (IIS)

Investigator-initiated studies are studies with scientific and medical merit developed and sponsored by an independent investigator/sponsor. An IIS may be clinical or nonclinical and is conducted without Terumo Blood and Cell Technologies participation. The type of support requested may be medical devices (e.g., disposable sets or equipment loans), limited monetary funding and/or technical support.

Responsibilities of the investigator/sponsor:

  • Study design and conduct
  • Data analysis and interpretation
  • Publication
  • Compliance with laws, regulations and guidelines
  • Reporting to regulatory authorities

Other responsibilities include:

  • Meeting specific milestones as per the contract
  • Submitting regular updates to the Terumo Blood and Cell Technologies External Research Program
  • Authoring the final study report

The following elements are considered in each review:

  • Qualifications of the investigator/sponsor
  • Alignment with current business and regulatory strategies
  • Scientific worthiness and soundness of proposed research
  • Appropriateness of the amount and type of support requested, as well as the impact on available budget or resources; overall availability for new IIS funding can vary per year


The device under study must be approved or cleared for use in your country. We do not accept proposals for studies intended to support registration, labeling changes or other regulatory activities.

The External Research Program will consider proposals related to the following areas of research interest:

COVID-19
  • COVID-19 therapies or vaccines
Autologous Biologics
  • Platelet-rich plasma (PRP) for soft tissue applications
  • Bone marrow aspirate concentrate (BMAC) to promote bone formation with or without advanced biomaterials
Blood Center Services
  • Studies supporting innovative methods of measuring or quantifying clinical outcomes of transfused blood products in patients, and in particular pediatrics
  • Hemovigilance studies on safety and health aspects of frequent apheresis platelet donation
  • Real-world data demonstrating the value of Terumo Blood and Cell Technologies’ software applications and device connectivity within the blood center environment
Therapeutic Systems
  • Optimization of cell collections for stem cell transplantation and cell and gene therapy
  • Therapeutic apheresis with or without selective removal of specific disease mediators

IIS Proposal Process



Create Profile

Log in to manage, review or submit your IIS proposal.

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Note that this portal should not be used for grants, donations or charitable contribution requests.

For questions regarding the External Research Program, send an email to ERP@terumobct.com.

Frequently Asked Questions



Who may apply?

  • Qualified investigator/sponsor criteria:
    • Trained in Good Clinical Practice
    • Committed to the protection and safety of patients
    • Sufficient experience and qualifications to successfully conduct the study


Must I apply online?

  • All proposals must be submitted online through the IIS proposal submission portal.


What does Terumo Blood and Cell Technologies consider an investigator-initiated study?

  • A clinical or nonclinical study conducted without the participation of Terumo Blood and Cell Technologies for which the IIS investigator/sponsor requests Terumo Blood and Cell Technologies to provide any or all of the following: funding, medical device, laboratory device and/or training.


Once my IIS proposal has been accepted. What documents are needed?

  • Curriculum vitae
  • Protocol synopsis
  • Completed IIS proposal information form
  • If monetary support is requested, a budget is required

View IIS Proposal Information Form



What information should be included in the protocol synopsis?

  • Study title
  • Background/significance of the study
  • Objective and rationale
  • Study design
  • Primary endpoints
  • Secondary endpoints
  • Description of study population
  • Summary of study procedures
  • Statistical methodology
  • Projected timeline


How long does the review process take?

  • The External Research Committee will review submissions over a two- to three-month period. However, one of the outcomes of the review may be that more information is needed. In this case, the review period may be extended.


May I use a contract template from my home institution?

  • No, Terumo Blood and Cell Technologies contract templates will be used.


How long does the contract process take once I have received an acceptance email?

  • The contract process can vary in timing depending on the complexity of the project; expect approximately three to four months.


Investigator-Initiated Studies

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