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)

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