Sanara MedTech supports unique, independent clinical research studies of scientific and business merit. The IIS program mission is to encourage investigators to pursue and publish original research in areas relevant to the company's business. The committee serves to assure the program meets all applicable ethical, scientific and strategic criteria, including conformance with applicable Sanara MedTech and regulatory agency requirements. Results of these studies are usually published in peer-reviewed medical journals and/or presented at local and global medical congresses, to share knowledge with the entire medical community.
To learn more about the process please click on the available links.
ABOUT THE IIS PROGRAM
An investigator-initiated study is a research effort in which the principal investigator (PI) not only designs and implements the study, but also acts as the study sponsor. The sponsor is the individual (or entity) responsible for understanding and complying with any and all regulatory requirements related to the study. Sanara MedTech cannot act as the sponsor for third-party research studies.
As a study sponsor, the PI is responsible for:
- Designing the protocol and conducting the scientific investigation
- Understanding and complying with any and all pertinent laws, regulations, and guidelines
- Understanding and complying with any and all requirements of institution(s) with which they are associated or in which research will occur
- Reporting safety data to regulatory authorities, the IRB/IEC, and the company
- Registering the study on a public website, if applicable
Under the IIS program, the PI is also responsible for:
- Disclosing business affiliations
- Meeting applicable deadlines
- Submitting study status updates as required in the study agreement
- Informing the company of key study-related milestones or events
- Delivering a draft manuscript and/or a final draft report of publishable quality upon completion of the study
To proceed, see sections on submission requirements and forms.
BEFORE APPLYING FOR THE IIS PROGRAM
- Sanara MedTech Inc. and applicant will comply at all times with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), including its implementing regulations.
- Sanara MedTech will not provide charitable donations, grants, or products in exchange for business.
- Sanara MedTech Inc. does not provide “unrestricted” grants outside the scope of the requestor’s written application and budget that is submitted for review. If the request is approved, the designated purpose for which it was reviewed is the only one for which the grant may be used.
- Grants are only given to reputable healthcare or healthcare-related organizations, and not to individuals.
- Each Request shall be reviewed in context of the Sanara MedTech Code of Conduct and the reflection participating in the requested support will have on Sanara MedTech.
- No Request shall be approved as an inducement to a health care provider to purchase, prescribe, utilize or recommend any Sanara MedTech product.
- To proceed, see sections on submission requirements.
FREQUENTLY ASKED QUESTIONS
Who can assist with the IIS proposal form?
Direction to the IIS proposal may be provided by Sanara MedTech sales personnel, however sales and marketing is separate from the grant request, review process, and final decision.
Who is responsible for the research process?
The applicant is responsible for the research process and compliance to requirements during the study in accordance with all local regulations, ISO 14155 and ICH GCP.
What are the requirements to be an investigator?
Applying investigators should have applicable training, knowledge, and proficiency in the relevant therapeutic area, as well as appropriately trained staff and facilities to conduct the research.
Can Sanara MedTech provide free product for research purposes?
Sanara MedTech does not supply commercially available product for free to the HCP for clinical research purposes.
SUBMISSION REQUIREMENTS for an Investigator Initiated Study (IIS)
- Completed Letter of IIS Proposal (limit to 1000-word count) which will aid Sanara MedTech in understanding the goals and purpose of the research. An outline of the desired information to be included in the proposal can be accessed below:
IIS Proposal Outline - Upon review, additional follow-up information may be requested, which may include scientific information (i.e. protocol), anticipated publications, detailed SoW / budget, NPI #, research coordinator contact info, GCP Training Certificates etc, Copies of CV and Medical License of Principal Investigator.
- Please Email the completed IIS proposal to the applicable department
For Basic Science Research: [email protected]
For Clinical Patient Study Research: [email protected] - A confirmation email will be sent upon receipt of the proposal.
PROCESS AND EXPECTED TIMELINE FOR REVIEW
- Proposals are accepted on a continuous basis.
- Regularly scheduled review meetings will occur, and a response will be provided to the submitter within 30 days of decision.
- Upon approval, the submitter will need to provide W-9 for funding institution.
- While Sanara MedTech Inc. reviews many worthy ideas and projects, we are not able to guarantee funding to all submitted proposals.
