Here you can download the XVIVO Investigator Initiated Research proposal form. The first two pages include a practical guide explaining what to consider when filling out the form. Read more about the application process above.
Investigator initiated research
Our commitment to research & innovation
XVIVO is committed to supporting the advancement of preclinical and clinical research that relates to disease states, conditions, and treatments relevant to the company’s mission. We recognize the important role that research plays in our core values and mission, both in benefits to patient care and the advancement of medical technology, treatment, and knowledge.
XVIVO supports a global network of Investigator Initiated Research (IIR) with the goal of improving patient care and clinical outcomes. Investigator Initiated Research is open to all investigators who are interested in applying for support of their independently developed research.
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What is Investigator Initiated Research (IIR)?
Investigator Initiated Research refers to independent research initiated and led by external investigators or institutions without direct control by the manufacturing company. These initiatives may be clinical (prospective or retrospective), pre-clinical (e.g., animal studies), or other scientific activities such as real-world evidence generation, device performance evaluations, or exploratory research on new applications.
The investigator or institution acts as the sponsor of the study and is fully responsible for the study concept, protocol development, regulatory and ethical approvals, execution, and dissemination of results.
For clinical studies involving human subjects, the sponsor must adhere to the principles of Good Clinical Practice (GCP) as outlined in ISO 14155 or other applicable national or international standards. This includes obtaining applicable regulatory and/or ethical approvals, implementing proper data control and documentation practices, and ensuring compliance with all relevant regulatory requirements to protect subject safety and ensure data integrity.
The application process
The application process includes submission of a standardized proposal form provided by XVIVO which can be downloaded on this page. The proposal form is used to submit your research request to XVIVO for internal review.
The application process is divided into two steps: an initial step with limited request for documentation (Section I in the form), and a second step where more extensive information is requested (Section II in the form).
Use the arrows below to expand each item and learn more about the process.
1. Application | Step one
Download the XVIVO Investigator Initiated Research proposal form.
If you have not discussed your proposal with XVIVO, please complete ONLY SECTION I: Abstract of research proposal, and submit this for initial review.
If you have discussed your proposal with XVIVO and a full proposal has been requested: Please complete BOTH SECTIONS I and II and submit this for full review.
The proposal form should be sent to iir@xvivogroup.com together with a copy of the Principal Investigator CV (if not provided to XVIVO previously).
If a more extensive research plan (not mandatory) is available, please attach the plan to the email.
You will receive a confirmation of successful delivery of the application. Should the application be incomplete or unclear, a request for additional information will be sent to you.
2. Research Board review
Your application will be assessed by the appropriate internal, cross-functional Research Board at the next available review meeting.
The Research Board at XVIVO will review the initial Section I and determine if the proposal is potentially eligible for XVIVO support. In that case you will be asked to complete Section II of the form (if not done already).
XVIVO will always provide comments explaining the basis for a decision.
3. Application | Step two
If you have been asked to complete Section II: Full research proposal of the form, please fill in Section II and send to iir@xvivogroup.com.
Please note that the final support decision is made on the full submission (Section I and Section II) and not Section I alone.
4. Research Board review
The Research Board thoroughly reviews your application, evaluating aspects such as feasibility, relevance, and the potential impact of the proposed research. The aim is to ensure that it provides meaningful scientific value and contributes to advancements in the field.
The outcome of the review may be a rejection, an approval with modifications, or a full approval. XVIVO will always provide comments explaining the basis for the decision.
5. Contracting
If the full submission is approved by the Research Board, a research agreement will be drafted and negotiated with your institution.
Support will be contingent upon full execution of a research agreement between your institution and XVIVO.