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.
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 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:
Other responsibilities include:
The following elements are considered in each review:
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.
Log in to manage, review or submit your IIS proposal.
For questions regarding the External Research Program, send an email to ERP@terumobct.com.
Who may apply?
Must I apply online?
What does Terumo BCT consider an investigator-initiated study?
Once my IIS proposal has been accepted. What documents are needed?
View IIS Proposal Information Form
What information should be included in the protocol synopsis?
How long does the review process take?
May I use a contract template from my home institution?
How long does the contract process take once I have received an acceptance email?