Investigator-initiated research

In pursuit of better care for more people, we partner with physicians and institutions worldwide to discover what’s next in treating the challenges of cardiovascular health. We are dedicated to supporting investigator-initiated research because we believe that through research and discovery, we advance patient care together.

Investigator-initiated research (IIR) application submission & review process

Thank you for your interest in submitting an IIR application. Below are the simple application steps to request support / funding:

Step 1: Complete and submit IIR application. You can save your progress and log back in to finish if necessary.

Step 2: The following documents are required for submission. Please provide in a PDF format, attaching to your application:

Letter from Institution requesting funding and/or additional support for their proposed study
Draft protocol or study synopsis
Current CV signed and dated (Note: All sensitive information i.e., DOB, Social Security number should be removed prior to submission.)
Detailed budget estimate

Once submitted, the application is reviewed for completeness.

If the IIR request meets the initial requirements, the approval process begins with a scientific review to ensure merit, significance, and available funding. If accepted, the IIR application will be sent to the Grant Committee for legal and regulatory review.

The applicant will be contacted directly once a Grant Committee decision is made. Updates will be provided to the applicant throughout the review process.

Begin application

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

Review qualifications

We mindfully review all IIR study requests with a detailed assessment by a cross-functional team. IIR Requests will be assessed with the following criteria:

Scientific Merit
Realistic sample size, timelines, budget and statistical plan
Correlation with business strategy
Diagnostic or therapeutic intent
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
Clinical outcome is achievable

Site roles & responsibilities as the sponsor

Text:

	Industry sponsored	Investigator sponsored
Protocol ownership	The company owns the protocol and invites investigators to participate	The sponsor institute owns the protocol and can submit multiple funding sources for support
Data	The company manages data with subject consent; the investigator typically has access to their data only	The sponsor institute manages data with subject consent and gives company rights to use the data
Monitoring	The company is responsible for conducting appropriate monitoring and may monitor the data to ensure validity	The sponsor institute is responsible for study conduct and data validity
Intellectual Property	The company typically has rights to all intellectual property developed from the study data	The intellectual property is negotiated by study protocol
Deliverables	Usually determined by the company	The investigator and company determine as part of any research grant agreement
Publication	The company and steering committee determine authorship	The investigator determines authorship

Definitions:

Sponsor	Principal Investigator (PI)
An individual, company, institution, or organization that takes responsibility for the initiation, management, and / or financing of a clinical trial. Note: The regulatory/legal definitions of "Sponsor" and associated indicators of sponsorship may vary by geography.	An individual who is responsible and accountable for conducting the study at a study site. The Pl assumes full responsibility for the treatment and evaluation of the Clinical Subjects and for the integrity of the research data and results at the respective study site. Note: The Principal Investigator may also be the Sponsor of the clinical study.

Responsibilities:

Sponsor (ISO 14155):

Clinical quality assurance and quality control
Clinical investigation planning and conduct
Selection of clinical personnel
Preparation of documents and materials
Conduct of clinical investigation
Monitoring
Safety evaluation and reporting
Clinical investigation close-out

Principal investigator (ISO 14155):

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 FDA, MedTech, Eudamed (European Commission) (pending 2022) requirements, local, laws, and guidelines.

Please refer to the ClinicalTrials.gov Protocol Registration and Results System Final Rule Information website https://prsinfo.clinicaltrials.gov and/or Eudamed website (pending 2022) European Commission, official website (europa.eu)
Design the protocol and conduct the scientific investigation.
Gain approval through Institutional Review Board (IRB) / Independent Ethics Committee (IEC).
Register study with Clinicaltrials.gov and/or Eudamed. Click this link to learn how: https://clinicaltrials.gov/ct2/manage-recs/how-register Eudamed (pending 2022).
Control study protocol and manage the data generated during the study.
Submit study status updates to the company 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.

If you have questions about the IIR Principal Investigator/Site Roles and Responsibilities, please contact us at IIRStudy.IGTDevices@philips.com.

Areas of interest

Philips Image Guided Therapy Devices (IGTD) will consider all relevant research proposals that meet the IIR study criteria. Please find examples of Philips’ IGTD current areas of interest below.

Note: Funding is limited. Support for studies will be considered from both a scientific and financial lens.

Peripheral Vasculature

Peripheral artery disease and peripheral venous disease treatment and visual guidance including:

Procedural optimization of the Tack Endovascular System
Combination use of Philips portfolio devices in real world diverse patient populations
Personalization of atherectomy strategy in the context of multiple available options
Intravascular guidance of endovascular procedures
Health economic outcomes and analysis
Procedural best practices, efficiencies, and long-term clinical outcomes
Use of Philips device portfolio in all stages of venous disease
Use of Tack Endovascular System for post-PTA dissection repair

Interventional Cardiology

Clinical and economic outcomes of Philips imaging, physiology, and/or therapeutic tools in CAD including:

Use of Philips tools to assess or improve emerging cath lab therapies
Personalization of treatment strategies using Philips diagnostic or therapeutic tools

Heart Rhythm Management

Managing Cardiac Implantable Electronic Device (CIED) leads - lead extraction for infectious and non-infectious indications, managing patients with CIED leads
Complex inferior vena cava (IVC) filter identification and retrieval
Intracardiac echocardiology (ICE) for structural heart interventions

Application

Click here to launch the Image-guided therapy devices IIR application.

Disclaimer

Results are specific to the institution where they were obtained and may not reflect the results achievable at other institutions. Results in other cases may vary.

Investigator-initiated research