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
Just a moment, the page is loading...