STUDY QUALIFICATIONS
We carefully review all support requests. IIS applications undergo extensive assessment by a cross-functional team consisting of medical, clinical, and other technical staff.
The following criteria are important factors for assessing IIS proposals:
- Safety and welfare of the subjects
- Originality or novelty of research
- Scientific and statistical soundness
- Impact on clinical and commercial strategies
- Impact on intellectual property portfolio
- Consideration of good clinical practices (GCP)
- Consistency with governmental and corporate health care compliance directives
The company generally does not provide support for studies:
- That involve investigational/pre-cleared/pre-market devices
- In which the primary study objective is intended to support a registration effort, labeling changes, or other regulatory action