IGT Investigator-Initiated Study
At Philips Image Guided Therapy, we challenge the status quo. We are dedicated to supporting Investigator-Initiated Studies (IIS). In pursuit of excellence, we partner with physicians and institutions worldwide to discover what’s next in minimally invasive procedures to help caregivers decide, guide, treat and confirm the right therapy for each patient.
Investigator-Initiated Study (IIS) application submission and review process
Thank you for your interest in submitting an IIS application to Philips Image Guided Therapy (IGT), i.e., IGT-Devices and IGT-Systems. Below are the simple application steps to request support / funding:
Step 1: Complete and submit the IIS application online.
Step 2: The following documents are required for submission. Please provide in a PDF format, attaching to your application:
- Official letter from the Institution, including support from the Managing Director of the hospital or the applicant, requesting funding and/or additional support for the proposed study
- Current CV of the Principal Investigator, dated and signed (please remove all sensitive information before uploading, i.e., DOB, Social Security number, etc.)
- Draft protocol or at minimum a study synopsis: Preliminary data (if available), Study design, Methods, Statistical plan, Study timeline (Expected start date/First Patient In, End recruitment/Last Patient Out, Database Lock, Final Report/Publication)
- Detailed study budget: Details on the expected costs leading to the budget requested. You may use our budget template or your own preferred format.
Once submitted, the application is reviewed for completeness.
If the IIS request meets the initial requirements, the review process begins with a scientific review to ensure merit, significance, and available funding. The IIS application will also go through legal and regulatory review.
The applicant will be contacted directly once a Review Committee decision is made. Updates will be provided to the applicant throughout the review process.
To ensure your study request is directed to the appropriate team, please choose IGT Devices or IGT Systems below.
IGT-Devices | IGT-Systems |
If your study involves specific tools, instruments, or equipment (e.g., catheters, balloons, IVUS) used during procedures indicated in "Areas of Interest" select IGT-Devices. | If your study focuses on integrated systems and platforms (e.g., Coronary Tools, SmartCT, DoseAware) that facilitate image-guided procedures indicated in "Areas of Interest" choose IGT-Systems. |
If you still have questions after reviewing the content on this site, please contact us at [email protected] (IGT-Devices) or at [email protected] (IGT-Systems).
Review qualifications
We mindfully review all IIS requests with a detailed assessment by a cross-functional team.
IIS requests will be assessed with the following criteria:
- Study must have an on-label product indication
- Clinical and scientific merit
- Appropriate sample size, timelines, budget, and statistical plan
- Compliance with international regulations and guidance documents relating to the protection of human subjects, national standards, and compliance with medical device regulation
- The requested support is justified given the tasks and deliverables outlined. It is in accordance with the fair market value for the activities required to conduct the study and produce the deliverables, aligning with Philips' best practices.
- Alignment with Philips’s therapeutic/diagnostic areas or areas of interest and current business strategy
- Study should address new ideas, new fields, explore gaps in existing knowledge. Proposal is unique (i.e., not unnecessarily duplicative)
- Principal Investigator (PI) has adequate study experience and the Institute has the infrastructure to conduct the Investigator-Initiated Study
- IIS resulting in valuable information regarding clinical outcomes, health economics or reimbursement possibilities
- Clinical outcome is achievable
Principal Investigator's / Institution's roles & responsibilities as the sponsor
With this IIS application you agree to take the roles of Sponsor and Principal Investigator as per ISO 14155:2020.
Philips sponsored | Investigated Initiated 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 |
Philips sponsored | Investigated Initiated 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 and liability for the initiation, management, and arranges the financial setup. Note: The regulatory/legal definitions of "Sponsor" and associated indicators of sponsorship may vary by geography. | A qualified 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. |
Sponsor | Principal Investigator (PI) |
An individual, company, institution, or organization that takes responsibility and liability for the initiation, management, and arranges the financial setup. Note: The regulatory/legal definitions of "Sponsor" and associated indicators of sponsorship may vary by geography. | A qualified 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):2020
- 9.1 Clinical quality management
- 9.2 Clinical investigation planning and conduct
- 9.2.1 Selection and training of clinical personnel
- 9.2.2 Preparation of documents and materials
- 9.2.3 Conduct of clinical investigation
- 9.2.4 Monitoring
- 9.2.5 Safety evaluation and reporting
- 9.2.6 Clinical investigation close-out
Principal investigator (ISO 14155):2020
The role of the principal investigator is to implement and oversee the management of 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. The principal investigator is responsible for ensuring adequate training and qualification of the investigation site team and for maintaining oversight of their activities. The principal investigator may delegate tasks to qualified members of the investigation site team but retains responsibility for the clinical investigation. This also applies when activities are outsourced to an external organization by the principal investigator in which case he/she shall implement procedures to ensure the integrity of all tasks performed and any data generated by this external organization.
- 10.1 General
- 10.2 Qualification of the principal investigator
- 10.3 Qualification of investigation site
- 10.4 Communication with the Ethics Committee (EC)
- 10.5 Informed consent process
- 10.6 Compliance with the Clinical Investigation Plan (CIP)
- 10.7 Medical care of subjects
- 10.8 Safety reporting
Understand and act in accordance with FDA (Food and Drug Administration, United States of America), MedTech, Eudamed (European Database on Medical Devices, European Commission) 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 (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 https://clinicaltrials.gov/ct2/manage-recs/how-register and/or Eudamed website).
- 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 IIS Principal Investigator's/Institution's Roles and Responsibilities, please contact us at [email protected] (IGT-Devices) or at [email protected] (IGT-Systems).
Areas of interest
Philips Image Guided Therapy Devices (IGT-D) and Philips Image Guided Therapy Systems (IGT-S) will consider all relevant Investigator-Initiated Study proposals that meet the IIS study criteria. Please find examples of Philips’ IGT-D and IGT-S current areas of interest below.
Note: Funding is highly competitive. Support for studies will be considered from both a scientific and financial lens.
Image Guided Therapy Devices (IGT-D) – Areas of Interest
Peripheral vasculature
Peripheral artery disease and peripheral venous disease treatment and visual guidance including:
- 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
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
Cardiac Solutions
- 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
Image Guided Therapy Systems (IGT-S) – Areas of Interest
Coronary
- Integration of pre-operative imaging in live procedural guidance
Vascular
- Use of Philips portfolio products in arterial (aortic and peripheral) and venous procedures
Electrophysiology
- Combination of Philips portfolio product(s) with EP mapping
Structural and Congenital heart disease
- Integration of pre-operative imaging for real-time procedural guidance
- Cone Beam CT-supported structural and congenital heart procedures
- Protocol optimization to balance x-ray dose with image quality and device visualization
- Data collection to facilitate AI automation for improved procedural efficiency
Interventional neurovascular and hybrid neurosurgery
- Utilization of Philips solutions in endovascular and minimally-invasive neurosurgical procedures
- Continuous improvement of 2D and 3D image quality
Interventional oncology
- Use of Philips portfolio product(s) in tumor embolization, biopsy and ablation procedures
- Cone Beam CT supported interventional oncology procedures
Interventional pulmonology
- Cone Beam CT to support image-guided bronchoscopic interventions
Application
To ensure your study request is directed to the appropriate team, please choose IGT Devices or IGT Systems below.
IGT-Devices | IGT-Systems |
If your study involves specific tools, instruments, or equipment (e.g., catheters, balloons, IVUS) used during procedures indicated in "Areas of Interest" select IGT-Devices. | If your study focuses on integrated systems and platforms (e.g., Coronary Tools, SmartCT, DoseAware) that facilitate image-guided procedures indicated in "Areas of Interest" choose IGT-Systems. |