Image Guided Therapy Devices (IGTD) Clinical Affairs

Investigator-Initiated Research

Through research and discovery, we advance patient care.

 

At Philips, we challenge the status quo. We are dedicated to supporting Investigator-Initiated Research. In pursuit of excellence, we partner with physicians and institutions worldwide to discover what’s next in treating the challenges of cardiovascular health.

Investigator-Initiated Research (IIR) Frequently Asked Questions

 

Q: Who can apply for an IIR grant funded by Philips IGTD?

A: Principal Investigators/Sites wanting to partake in a research study of clinical relevance to Philips IGTD products and/or related therapeutic areas are eligible to apply. 

 

Q: How do I apply for a grant to fund my IIR study?

A: To apply, you will need to register and create an account on the Philips IGTD Investigator Initiated Research (IIR) application. 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 IIR application submission and review process?

A: Click here to read the Investigator Initiated Research (IIR) Application Submission & Review Process. 

 

Q: How long does the application review process take?

A: Our goal is to review each IIR 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 IIR consideration? 

A: Studies with an on-label product indication and a valid study proposal are eligible for IIR consideration. 

 

Q: What are the Areas of Interest? (Examples below, but not limited to the following)

A: Peripheral Vasculature - Peripheral Artery Disease and Peripheral Vascular Disease treatment and Visual Guidance

Interventional Cardiology - Complex PCI and Functional Guidance

Managing Cardiac Implantable Electronic Device (CIED) Leads - Safe Extraction of Infected and/or Malfunctioning Leads

 

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 here on the Philips website.

 

Q: Can I apply for funding for an investigational device (i.e. device not yet approved or not commercially available in the country)?

A: No. The Philips IGTD IIR program does not provide funding for investigational devices/off-label use. 

 

Q: What if my IIR request is denied?

A: If your IIR request is denied, this does not indicate the study lacks scientific significance, but the business will not be moving forward with supporting your study proposal. However, we welcome you to apply with future study ideas.

 

Q: If my IIR request is approved, will I receive a contract template? 

A: If your IIR request is approved, Philips IGTD 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. You must get approval from the Institutional Review Board (IRB) / Independent Ethics Committee (IEC).

 

Q: When will I receive funding or product(s) if my study is approved?

A: Once an IIR contract is fully executed, (contract signed by all parties involved) and the study is approved by the IRB or IEC. 

Philips 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.

Click here to access the budget template. 

 

Q: What items are not reimbursable via IIR funding?

A: The following items are excluded from IIR 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 IIR study?

A: Yes, we do have the option to provide Philips IGTD products and during review this request will be considered. 

 

Q: Will payments be reported on the physician financial transparency reports?

A: Yes. Philips IGTD complies with all mandated transparency regulations.

Questions?

 

If you still have questions after reviewing the content on this site, please contact us at IIRStudy.IGTDevices@philips.com.

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