Shockwave Medical Investigator-Sponsored Research Program

Create Account

Shockwave Medical’s Investigator-Sponsored Research (ISR) Program is committed to supporting external research focused on calcified arterial disease and refractory angina.

ISR Portal

All submissions and communications are conducted through the ISR portal

Steps to Submit a Research Proposal:

Create and validate a portal account
Title the submission and agree to the attestation statement
Complete submission form
Upload CV (required) and other supporting documents (optional)
Information can be saved and returned to as needed

ISR Program Overview

Shockwave Medical provides financial and/or product support for independent research activity. Our global research program is open to all investigators qualified to conduct clinical or pre-clinical research.

After submission, a proposal undergoes initial review; only clear and complete proposals will progress to a monthly committee review, where proposals are considered according to the following factors:

Whether the research furthers Shockwave Medical’s mission
Overlap with ongoing/planned research
Scientific rigor and quality of proposal
Likelihood of generating novel and meaningful information
Appropriate size and scope of the study
Fair market value
Qualifications and capabilities of the investigator
Compliance with regulatory requirements
Any other criteria deemed appropriate

If funding is approved, a research agreement is negotiated between the research sponsor and Shockwave Medical, containing the final budget and research protocol. Investigators are expected to provide regular updates on study progress and to share their findings via conference presentations and in peer-reviewed journals.

Responsibilities of the Investigator and Shockwave Medical

The study sponsor and the principal investigator have full and final discretion and responsibility for all aspects of the study including:

Study design and protocol authorship
Study operation
Data collection, storage and analysis
Authorship of all publication activity
Compliance with all laws and regulations applicable to research sponsors

Shockwave Medical will provide financial and/or product support as agreed upon by both parties in a written ISR Research Agreement.

Shockwave Medical will not provide operational support; this is the responsibility of the sponsor-investigator
Shockwave Medical will offer guidance and feedback throughout research activities

Approval Process

Upon submission, a proposal undergoes an initial review. Only clear and complete proposals will progress to a monthly committee review. During evaluation, the following factors are considered:

Whether the research furthers Shockwave Medical’s mission or provides novel information (diagnostic, treatment or disease areas) of interest to Shockwave Medical
Potential overlap with ongoing/planned research activities
Scientific rigor and quality of research proposal
Likelihood to produce novel and meaningful information
Appropriate size and scope for the study
Fair market value
Investigator qualifications, expertise and prior research performance
Compliance with regulatory requirements regarding unapproved devices or uses
Any other criteria deemed appropriate

The review committee may directly approve projects that meet the evaluation criteria outlined above. Alternatively, the committee may suggest minor changes to improve the scientific merit of the research or directly decline projects that do not meet the criteria. Shockwave Medical provides no guarantees to provide support for your proposal.

What to Expect Once Approved

Research Agreement: If funding is approved, a research agreement is coordinated between Shockwave Medical and the investigator’s institution. The research agreement protects physicians, patients and Shockwave Medical by defining roles and expectations. It addresses issues such as understanding the requirements of a sponsor-investigator, intellectual property ownership and publication.

To execute a research agreement, Shockwave Medical and the sponsoring institution negotiate:

The various clauses of the research agreement legal contract
Time period for Shockwave Medical review of final study results prior to publication
Details of the final study protocol
Progress-based milestones for financial and/or product support

Investigator Communication: Investigators are expected to provide regular study updates to Shockwave Medical throughout the active stages of research. The following periodic updates are required:

Register the trial on a clinical trials registry (e.g., clinicaltrials.gov)
Monthly total number of patients enrolled and devices used
Quarterly predictions for milestone achievement dates
Actual milestone achievement dates

Financial/Product Support: Shockwave Medical and the study sponsor negotiate the size and distribution of study support to ensure funding throughout the study lifecycle and encourage continued progress. After confirming achievement of a milestone, Shockwave Medical will pay the agreed upon amount within 30 days of receiving an invoice.

Publication Activity: Conference presentations and peer-reviewed publications are the ultimate goals of a successful research project. This activity benefits patients and society, as well as the wider research community.

Investigators should coordinate with Shockwave Medical their plan for conference presentation and peer-reviewed publishing
Shockwave Medical has the right to review summary results (e.g., abstract, draft manuscript, etc.) before public disclosure
No Shockwave Medical employees will be an author on your publication
Investigators should post results of the study on a clinical trial registry (e.g., clinicaltrials.gov)