Investigator-Initiated Studies (IIS) Program: Asia Pacific Region

At Terumo, we advance medical research and enhance patient care through innovative solutions. Our Investigator-Initiated Studies (IIS) Program supports researchers pioneering new treatments and methodologies to improve health outcomes. We may support external clinical investigations conducted by researchers who demonstrate high ethical and scientific standards in accordance with the ICH E6(R2) Guideline for Good Clinical Practice (GCP).

Intent of Our Program

Our IIS program aims to empower investigators by providing access to Terumo’s cutting-edge medical technologies and expertise. We understand the importance of independent research in the clinical landscape, and we are committed to fostering collaborations that drive meaningful advancements in patient care. Through this program, we facilitate the initiation and execution of clinical studies led by qualified investigators, enabling them to explore novel approaches that can lead to significant breakthroughs.

What We Support

We support IIS that align with our mission to improve patient outcomes and are conducted ethically and responsibly. This includes a focus on studies utilizing our medical devices and therapies in innovative ways, as well as multidisciplinary research that addresses pressing healthcare challenges. Support can be extended in the form of product, training on optimal use as per label, financial grant, or a combination of above.

What We Don’t Support

However, please note that our program does not support studies that are primarily aimed at marketing our products or that do not meet ethical and scientific standards. We also do not support grants utilised to build new infrastructure or purchase capital equipment. Support for ongoing clinical programs already a part of your organisation’s routine operations and hiring of staff or any overhead expenses not dedicated to the study are out of the scope of our support. We prioritize research ensuring that all studies contribute positively to the medical and patient community.

Submission and Evaluation of IIS Information

The submission of your proposed IIS information and details will be subject to the certifications you have made. The receipt of IIS information by us does not imply that approval or support you are seeking will be given. The information will be used to evaluate the merits and aim of the IIS and whether it meets the criterion set by Terumo. We will notify you of the status of your submission once a decision has been made.

Responsibilities of the independent researcher:
  • Study design and conduct
  • Protocol review and approval
  • Obtaining the ethics committee and/or regulatory authority approvals, as required
  • Collecting the informed consents
  • Data analysis and interpretation
  • Publication
  • Compliance with local laws, regulations and guidelines
  • Reporting to regulatory authorities

Other responsibilities include:
  • Meeting specific milestones
  • Submitting updates to Terumo Medical Affairs personnel
  • Authoring final study report

How to Submit

The independent researcher submits a fully completed and signed proposal template via email to apac_iisprogram@terumo.co.jp

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