Smith+Nephew recognizes the importance of supporting Clinical Activities that lead to a greater understanding of our therapies and their potential applications, improved patient care, and new ideas for further research.
We accept unsolicited requests for research grants from academic and community-based clinician-scientists who are interested in conducting their own activity.
All investigators who are awarded support must provide Smith+Nephew with ongoing study updates and final deliverables.
We welcome proposals for a variety of clinical activities including Investigator Initiated Studies (IISs), Manuscript and Abstract Preparation activities, Collaborative Clinical Research projects and Real World Evidence activities. Click the tiles at the bottom of this page to learn more about each and proceed with proposal submission.
Requirements of The Sponsor investigator
As the sponsor of the study, the investigator and/or institution assume responsibility for all aspects of the study.
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Study design and protocol development
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Institutional and regulatory approvals and reporting
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IRB/EC approval
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Registration on ClinicalTrials.gov
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IND/IDE application submission
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Serious adverse event reporting to the FDA, IRB, and Smith+Nephew
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Study conduct in accordance with ICH GCP Guidelines and all applicable local and regulatory requirements
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Communication of all ongoing study updates (see section below)
- Reconciliation and closeout reporting (see section below)
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Clinical study report submission within 90 days of study completion
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Dissemination of study results in a peer-reviewed publication and/or at a medical meeting within 6 months of study completion
The Investigator needs to complete a study proposal and budget, these will be provided once you have selected the relevant study type below.
How to apply
Researchers are invited to submit their concept proposal using this Smith+Nephew submission portal via the ‘Submit Proposal’ button found on each study types page – found by first navigating to a Product type page. Each submission will be reviewed collectively by the Smith+Nephew Review Committee based on scientific merit and alignment with corporate research, key business objectives and development plans.
Approval Process
Support is awarded based upon scientific merit, as well as alignment with our research areas of interest and availability of resources. We may provide research grants in the form of funding, and/or study product.
Once submitted, a review of your proposal will take place including initial proposal and budget review, before moving on to an in-depth departmental review.
The Investigator should not commence work on a proposal until a fully executed contract is in place. All contracts are with the Institution not the Investigator.
Support Available
Smith+Nephew will provide all or partial funding for any Study that has been approved, it may also be possible for Smith+Nephew to provide the product(s) required directly, upon request. Investigators can not be paid directly. All funding is to the institution responsible for and housing the patient data.
Ongoing Study Updates
The Investigator must notify Smith+Nephew of the following updates for ongoing studies:
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Amendments to the study protocol
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Regulatory re-approvals
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Serious adverse events reports
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Achievement of study milestones related to milestone payments
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Subject enrollment progress (e.g., first subject in, last subject in, last subject out, etc.)
This can be done via the ‘Follow-up forms’ tab within your submitted proposal in the ‘My Submissions’ area.
Clinical Study Report
A clinical study report (CSR) is required within 90 days of study completion. The CSR should be written in accordance with the ICH Guidance for Structure and Content of Clinical Study Reports. Please refer to our guidance document here. A CSR template is provided for you here.
Publication
All
publications should comply with recognized ethical standards concerning publications and authorship, including
the Uniform Requirements for Manuscripts Submitted to Biomedical Journals, established by the International
Committee of Medical Journal Editors.
Smith+Nephew may request to be able to review the results at least 30 days in advance of submission for publication. For research
support that includes funding, the final milestone payment is dependent on submission for publication or
presentation of study results.
Benefits
Benefits to you: Funding support for research interests, Opportunities to collaborate with peers by
participating in multi-center S&N sponsored studies and Med Ed opportunities to attend advanced
courses/conferences
Benefits to S+N: Evidence to guide strategic direction for the life of the product, Clinical data to support
product claims & meet regulatory requirements