Investigator Research

PolyNovo is committed to supporting investigator-sponsored research studies involving NovoSorb Technology designed to provide valuable scientific and clinical information leading to improved clinical care and patient outcomes, which enhance human life

PolyNovo is currently focused on supporting studies which investigate the following areas of research interest involving NovoSorb Technology:

Usage in focused population studies (e.g. Pediatrics, Pressure wounds)
Investigation of procedural techniques (e.g. apply over bone)
Tissue quality and function following application (e.g. tendon glide, cosmesis)
Health economics assessments

Submission & Review Process

The review and approval of All Study support, financial and/or in-kind product, from PolyNovo, requires the completion of Steps One and Two detailed below.

Step One: Instructions for submitting Study Concept:

Complete and submit a Study Concept Proposal Form with copy of your CV. Please use the submit proposal link button below.

PolyNovo will review the study proposal. If the proposal receives initial approval, the investigator will then move to Step Two.

Step Two: Instructions for full study proposal. Please submit the following documents:

A draft protocol containing the study background, objective(s), design, projected timeline, inclusion/exclusion criteria, treatment details, follow-up visit schedule, and if available, statistical method/sample size
An itemized budget outlining specific items for which support is requested. The budget may include, but is not limited to, research activity-related personnel costs (e.g., research assistant, statistician, medical writer), data management expenses, and IRB review fees
Quantity of in-kind product requested, if applicable
Copy of Investigator’s CV, if not submitted with initial study concept proposal form
Copy of Investigator organization’s W-9 form in US, or W-8 if outside of US
Copy of non-profit 501 (c) (3), if applicable
Copy of Medical License, if applicable
Publication Plan for study, potential journals
Executed NDA between PolyNovo and Investigator/Institution

Full study proposals will be reviewed and assessed by the ISR Committee based on scientific merit, strategic fit, the investigator’s qualifications, product and research experience, along with requested monetary support. There is no guarantee of funding. Support will be provided only with a fully approved study agreement, payments are issued once milestones have been achieved as per study agreement.

The investigator is responsible for complying with all Local, State and Federal laws and regulations regarding human clinical studies. All human clinical studies evaluating off-label use of NovoSorb technology must comply with regulatory statutes. For example, in the US, proposed off- label human studies must be evaluated against 21CFR Part 812 to determine if an FDA Investigational Device Exemption is required.

Submit ISR Concept Proposal

Frequently asked questions

What is the PolyNovo’s review process for Investigator Sponsored Research (ISR) proposals?

ISR proposals are reviewed and considered by PolyNovo IRS committees using objective criteria to ensure that funding is provided based solely on the scientific merits and significance of the study proposal and not as an inducement to further PolyNovo’s commercial interests. All funding is awarded at Polynovo’s sole discretion.
What does PolyNovo consider when reviewing ISR proposals?

PolyNovo will consider funding requests, whether financial or in-kind, for IRS that (i) have scientific and medical merit;(ii) are developed and sponsored by an independent investigator or academic sponsor; and (iii) address meaningful scientific and/or clinical objectives consistent with PolyNovo’s research focus.
What guidelines and/or regulations does PolyNovo follow when considering ISR proposals?

PolyNovo will only support for ISR proposals that are able to demonstrate clear evidence of high ethical standards with respect to clinical research as stipulated by PolyNovo’s internal compliance policies, the International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) for human subjects.
How long will it take to review my ISR proposal?

PolyNovo makes every attempt to respond to ISR proposals in a timely manner, while adhering to a strict internal review process. Applicants submitting proposals will typically be notified of the results of the review process within 8-10 weeks. All PolyNovo funding, if approved, must be evidenced by a written agreement executed by both parties.
If my ISR proposal is approved, how long will it take to receive payment?

Once study milestones are achieved per the fully executed study agreement, payments are processed upon receipt of an invoice and payments are typically received within thirty to sixty days thereafter.
What additional information is required besides the completed study application form?

Medical License, if applicable

Study Protocol

Detailed Budget Breakdown

Projected quantity in-kind requested, if applicable

W9 if in US, W-8 if located outside of US (this is required for contracting)

501(c)(3), if applicable