For support consideration of pre-clinical research projects, please contact Contact Needed or your local SN representative for more information.
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.
Approval Process
It takes approximately 6 to 8 weeks for a proposal to be approved. Once approved the contracting process can take up to 3 months depending on the Institution’s internal contracting process. 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
S+N will provide all or partial funding for any IIS that has been approved. S+N would prefer to provide funding to cover the device cost, rather than provide devices, but it can be done if absolutely necessary. Investigators can not be paid directly. All funding is to the institution responsible for and housing the patient data. No exceptions.
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.)
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
Submission for publication in a peer-reviewed journal is required within 6 months of study completion. 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 at least 30 days in advance of submission for publication. Additionally, we must receive
evidence of submission for publication no later than 6 months following completion of the study. 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
SN has interest in evidence that demonstrates:
Clinical Impact - The clinical impact and outcomes associated with using SN products and technologies for various
procedures, in various settings, and different patient populations. Outcome measures may include performance
outcomes, clinican-reported outcomes, patient-reported outcomes.
Quality Impact - The impact of using SN products/technologies on quality of care, including physician, caregiver and
patient satisfaction, and institutional quality metrics associated with the implementation of SN products.
Economic Impact - Economic benefits associated with SN product implementation in different geographies and
reimbursement / payment models.
Process Impact - Process impacts related to implementation of SN products including workflow efficiencies,
operational efficiency gains, decreased procedural wait times.
Ear
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Tula Tympanostomy System
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WEREWOLF◊ COBLATION◊ System◊
Nose
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CMC Dissolvable Nasal Dressings
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COBLATION◊ Technology for Turbinate Reduction
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COBLATION◊ TURBINATOR◊ Turbinate Reduction Wand
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ENTACT◊ Septal Stapler
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HALO◊ Wand
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RAPID RHINO◊ with CMC Technology
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RAPID RHINO◊ SINU-FOAM◊ Dissolvable Post-Op Dressings
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RAPID RHINO◊ SINU-KNIT◊ Dissolvable Post-Op Surgical Dressings
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SERPENT◊ Articulating Instrumentation
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TURBINATOR
Ear
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COBLATION◊ Wands for adenotonsillectomy
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COBLATION◊ Technology for Adenotonsillectomy
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COBLATION◊ Technology for Airway Management
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EVAC◊ 70 XTRA and XTRA HP Wands
Requests that will be considered
Proposals that are aligned with SN research goals of evaluating the clinical and/or economic value of SN products and disease states to ultimately help patients live Life Unlimited.
The following study types may be considered for support:
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Prospective or Retrospective clinical studies involving Smith+Nephew products and technologies
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Health economics and outcomes research (HEOR)
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Support with manuscript publication or abstract presentation of existing findings
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Non-interventional research, such as epidemiology or outcomes studies, where the focus is on scientific
understanding of the disease
Requests that will not be considered
We do not provide support for the following:
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Proposals that are conditioned upon past or future purchases of Smith+Nephew products
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Requests that create a conflict of interest for Smith+Nephew