Terumo is open to receive and to discuss study proposals to support clinical data generation of its medical devices from real world evidence, observational studies as well as from prospective studies with a focus on specific subsets of patients.The main areas of interest for such studies are to:
An initial proposal application, using the protocol evaluation form, includes:
Terumo established an internal cross-functional review process to assess the requests for support of investigator-initiated studies. A timely and complete submission will be reviewed by an internal scientific committee and Grants & Donations committee.
Terumo may support external clinical investigations with researchers who can demonstrate clear evidence of high ethical and scientific standards that govern clinical research in human subjects as stipulated by the International Council for Harmonisation (ICH) E6(R2) Guideline for Good Clinical Practice (GCP).
Investigator-initiated studies have scientific and medical merit and are developed and sponsored by an independent researcher. An IIS is conducted independently without Terumo participation or involvement. The IIS researcher may request Terumo to provide any or all of the following: funding, medical device(s), laboratory test(s)/procedure(s), equipment and training.
The independent researcher submits a fully completed and signed Protocol Evaluation Form via email toIO.IIS_Management@terumo-europe.com
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