At BIOTRONIK we are committed to helping people with heart and blood vessel diseases live healthy, fulfilling lives. We work to support physicians and healthcare systems to provide meaningful innovations that result in effective care for their patients. Our company allocates resources each year to fund requests for grants which primarily support investigator initiated trials that advance the understanding of cardiac device therapy, as well as coronary and peripheral artery endovascular therapy with the goal to improve clinical outcomes and promote optimal patient care.
Submission and review process
Thank you for your interest in submitting an IIT application. Below are steps in applying:
Step 1: Complete and submit IIT application. You can save your progress and log back in to finish if needed.
Step 2: The following documents are required for submission. Please provide in a PDF format:
- Current CV signed and dated (Note: All sensitive information i.e., DOB, Social Security Number should be removed prior to submission).
Once submitted, the application is reviewed for completeness.
If the IIT request meets the initial requirements, the approval process begins with a scientific review by a board of BIOTRONIK experts to ensure merit, significance and available funding. The CRM board meets every second month and the VI board meets every quarter.
The applicant will be informed via email once the Board Committee decision is made.
Request for further information, if any, will be provided to the applicant throughout the review process.
Investigator-Initiated Trial (IIT) Review Qualifications
We mindfully review all IIT requests with a detailed assessment by a cross-functional team.
IIT Requests will be assessed with the following criteria:
- Scientific Merit
- Method: study design, justified sample size, eligibility criteria, primary and main secondary endpoints, timelines,
- Consistency of the requested budget with proposed study
- Correlation with clinical strategy
- Health economics or reimbursement purposes
- Adequate research experience and infrastructure to conduct the study
- Research should address new ideas, new fields, explore gaps in existing knowledge
Roles and Responsibilities
Investigator-Initiated Trial (IIT) Principal Investigator (PI) / Site Roles and Responsibilities as the Sponsor
Sponsor (ISO14155:2020): Individual or organization taking responsibility and liability for the initiation or implementation of a clinical investigation.
Principal Investigator (ISO14155:2020): Qualified person responsible for conducting the clinical investigation at an investigation site.
8.1 Clinical quality assurance and quality control
8.2 Clinical investigation planning and conduct
8.2.1 Selection of clinical personnel
8.2.2 Preparation of documents and materials
8.2.3 Conduct of clinical investigation
8.2.5 Safety evaluation and reporting
8.2.6 Clinical investigation close-out
Principal investigator (ISO14155:2020)
The role of the principal investigator is to implement and manage the day-to-day conduct of the clinical investigation as well as ensure data integrity and the rights, safety and well-being of the subjects involved in the clinical investigation. Understand and act in accordance with MedTech requirements, guidelines and laws.
Please refer to the ClinicalTrials.gov Protocol Registration and Results System Final Rule Information website. https://prsinfo.clinicaltrials.gov/
Design the protocol and conduct the scientific investigation.
Gain approval through Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
Register study. Click this link to learn how. https://clinicaltrials.gov/ct2/manage-recs/how-register
Control study protocol and manage the data generated during the study.
Submit study status updates as required in the study agreement.
Notify the company of significant study milestones as required in the study agreement
Provide a draft manuscript and study data upon completion of the study.
Report safety data to regulatory authorities, the IRB/IEC, and the company.
Understand and comply with any and all requirements of institution(s) which are associated or which research will occur.
Q: Who can apply for an IIT grant funded by BIOTRONIK?
A: Principal Investigators/Sites wanting to initiate a clinical study of clinical relevance to BIOTRONIK products and/or related therapeutic areas are eligible to apply.
Q: How do I apply for a grant to fund my IIT study?
A: To apply, you will need to register and create an account on the Clinical Grants Application Portal. If you have an account, you can login with your existing username and password.
Q: Am I required to apply online?
A: Yes, in order to be reviewed for potential funding, all grant requests must be formally submitted online.
Q: What is the IIT application submission and review process?
A: Click here to read the Investigator Initiated Trial (IIT) Application Submission & Review Process.
Q: How long does the application review process take?
A: Our goal is to review each IIT request and provide a rapid response. Note that depending on questions or additional information, it may take one to three months to review and provide feedback on the application.
Q: What are the Principal Investigator (PI)/Site Roles and Responsibilities?
A: Click here to review a detailed list of Roles and Responsibilities
Q: What types of studies are eligible for IIT consideration?
A: Studies conducted to further assess BIOTRONIK devices, within the scope of their market approved intended purpose are eligible for IIT consideration.
Q: Where can I find specific product information?
A: All product indication for use and specific safety information can be found in the Instructions For Use insert included within the product packaging. General product information can be found on the BIOTRONIK website.
Q: Can I apply for funding for a device that is not yet approved or not commercially available in the country?
A: No. The BIOTRONIK IIT program does not provide funding for unapproved (not commercially available) devices.
Q: What if my IIT request is denied?
A: If your IIT request is denied, this does not indicate the study lacks scientific significance, but rather that it is not fitting current BIOTRONIK clinical strategy. However, we welcome you to apply with future study ideas.
Q: If my IIT request is approved, will I receive a contract template?
A: If your IIT request is approved, BIOTRONIK will provide a contract template.
Q: When will the contract become valid?
A: The contract will only be valid when the contract is signed by all parties defined in the contract.
Q: Does my study need approval from an independent ethics committee?
A: Yes. As the study Sponsor, you will be responsible to get approval of the study from the Institutional Review Board (IRB) / Independent Ethics Committee (IEC), in accordance with national law. In addition, if the study involves submitting subjects to procedures additional to those performed under the normal conditions of use of the device that are invasive or burdensome, you will have to notify the concerned National Competent Authorities.
Q: When will I receive funding or product(s) if my study is approved?
A: Once an IIT contract is fully executed, (contract signed by all parties involved).
BIOTRONIK will distribute funds, product(s) support, or both, to the investigators/sites based on the milestones established in the contract. Payments can range from 30 - 90 days depending on the timeline identified in the contract.
Q: Am I required to provide a study budget?
A: When the grant application requires funding, a full budget breakdown is mandatory.
Q: What items are not reimbursable via IIT funding?
A: The following items are excluded from IIT funding:
- Reimbursable procedural costs through standard of care treatment
- Capital or reusable equipment
- Site equipment
- Non-research overhead or non-study related costs
- Costs not approved in the budget within the contract
Q: Do you provide products if requested for IIT study?
A: Yes, we do have the option to provide BIOTRONIK products and during review this request will be considered.