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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 proposal submission window for investigator-initiated studies for 2020 is closed. Areas of research interest are currently being updated. Please check back in 2021 or email questions to ERP@terumobct.com.

Overview

Thank you for your interest in working with Terumo BCT. The External Research Program (ERP) supports studies with scientific and medical merit developed and sponsored by independent investigators or academic sponsors around the globe. An investigator-initiated study (IIS) may be a clinical or nonclinical study conducted without the participation of Terumo BCT.


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
        • Monetary (in U.S. dollars)
        • Materials
        • Equipment

Other Opportunities



About the External Research Program

We have established an internal cross-functional review process when considering support for investigator-initiated studies. Submissions are reviewed by our external research committee.

Terumo BCT supports 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 BCT participation. The IIS investigator/sponsor may request Terumo BCT to provide any or all of the following: funding, medical device(s), laboratory device(s) and training.

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
  • Submitting updates to Terumo BCT External Research Program
  • Authoring 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.

Areas of Research Interest

COVID-19
  • Convalescent plasma, for example:
    • Collection and protocols
    • Universal Plasma
    • Mirasol PRT, where CE marked
    • Antibody titers
  • COVID-19 therapies or vaccines
Autologous Biologics
  • To be announced in 2021
Blood Center Services
  • To be announced in 2021
Therapeutic Systems
  • To be announced in 2021
Cell Therapy Technologies
  • To be announced in 2021
2020 Areas of Research Interest—submission window for 2020 is closed Autologous Biologics
  • Platelet-rich plasma (PRP) for infection prevention and/or wound healing in surgical procedures
  • Platelet-rich plasma (PRP) for soft tissue applications in large diarthrodial joints
  • Bone marrow aspirate concentrate (BMAC) to promote neovascularization
  • Bone marrow aspirate concentrate (BMAC) to promote bone formation with or without advanced biomaterials
  • Bone marrow aspirate concentrate (BMAC) to promote limb salvage


Blood Center Services
  • Hemoglobin content, platelet recovery and plasma quality of products processed on the Reveos® Automated Blood Processing System
  • Hemostasis: Novel blood products (whole blood, cold-stored platelets, freeze-dried plasma or cryoprecipitate)
  • Bacterial contamination/septic transfusion reactions in products processed on the Trima Accel® Automated Blood Collection System


Therapeutic Systems
  • Therapeutic plasma exchange (TPE) in autoimmune diseases
  • Apheresis in neurodegenerative diseases (dementia/movement disorders)
  • Red blood cell exchange (RBCX) in sickle cell disease
  • Cell collections for stem cell transplantation and cell gene therapy

IIS Proposal Process



Create Profile

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

Log In

Note that this portal is not to be used for Grants, Donations, Charitable Contributions 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 BCT consider an investigator-initiated study?

  • A clinical or nonclinical study conducted without the participation of Terumo BCT for which the IIS investigator/sponsor requests Terumo BCT 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 BCT 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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