Skip Ribbon Commands
Skip to main content
Sign In
{{'GLOBAL_MESSAGE_HEADLINE' | translate}}
{{'GLOBAL_MESSAGE_CHOOSE_LANG' | translate}}
en
日本語
中文
{{'GLOBAL_MESSAGE_OR' | translate}}
{{'GLOBAL_MESSAGE_SET_COUNTRY' | translate}}
{{'ELOQUA_BANNER_DECLINE_CONFIRM' | translate}}
{{'ELOQUA_BANNER_DECLINE_CONFIRM_CLOSE' | translate}}
{{'ELOQUA_BANNER_ACCEPT' | translate}}
{{'ELOQUA_BANNER_DECLINE' | translate}}
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

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.


IIS Proposal Application Package:
  • Required supporting documents in English
      • Principal investigator’s curriculum vitae
      • Protocol synopsis must include:
        • 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
      • Full protocol – optional
      • Full budget – required in USD, if monetary support is requested

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 committees.

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

We accept IIS proposals only during the submission timeframe:

  • For 2020 funding: October 2019 to February 2020
  • For 2021 funding: May 2020 to September 2020

Areas of research interest are updated annually.



Research opportunities for 2020:

Autologous Biologics Areas of Interest

  • Use of platelet-rich plasma to prevent infection of the surgical site during a sternotomy
  • Incorporating bone marrow aspirate concentrate into the treatment of critical limb ischemia patients to promote microvascularization

Blood Center Services Areas of Interest

  • Clinical data about the hemoglobin content, platelet recovery and plasma quality of products processed on the Reveos® Automated Blood Processing System compared to competitive devices and their relative benefits
  • Hemostasis/trauma - Clinical data about the performance of novel blood products (such as whole blood, cold-stored platelets, freeze-dried plasma or cryoprecipitate) to stop trauma-related bleeding
  • Laboratory or clinical data quantifying bacterial contamination or septic transfusion reactions in products processed on the Trima Accel® Automated Blood Collection System compared to competitive devices (including large-volume sampling)

Therapeutic Systems Areas of Interest

  • The role of therapeutic plasma exchange (TPE) in autoimmune diseases (e.g., new applications, mechanism of action, immunomodulatory effect, disease mediator removal, use of diagnostics to personalize care and health economic impact)
  • Potential role of apheresis in neurodegenerative diseases (e.g., dementia, Parkinson's disease and Alzheimer's disease)
  • Red blood cell exchange (RBCX) and sickle cell disease (e.g., prophylaxis use, role of inflammation, opioid sparing and pain management, and health economic impact)
  • Cell collections for stem cell transplantation (e.g., collection and/or mobilization optimization)
  • Cell and gene therapy (e.g., collection standardization, product purity and impact on downstream manufacturing processes)


IIS Proposal Process



Submit

Completely fill out the form to ensure a more efficient review

Decision

The principal investigator will be notified of the decision via email

Contract

All approvals are conditional upon successful execution of an IIS contract

Create Profile

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

Log In

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

View IIS Proposal Information Form

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.


What documents are needed for an IIS proposal?

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


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 Committees 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

Portal Log In

{{'SEARCH_MODAL_TITLE' | translate }}
{{'SEARCH_MODAL_OR' | translate }}

{{'SEARCH_MODAL_BROWSE' | translate }}
{{'SEARCH_MODAL_CHOOSE_LANGUAGE' | translate }} {{'SEARCH_MODAL_CHANGE_LANGUAGE' | translate }}
{{$index+1}}. {{s.label}}