35
Business consulting and management in the field of clinical
trials; pharmaceutical cost management services and drug
utilization review services; business management assistance
and consultation for clinical trials of observational
research designs, namely surveys, retrospective chart
review, prospective longitudinal cohort studies, post
approval safety studies (pass), registries, and
interventional studies for approved and investigational
drugs; arranging for sites to perform clinical trials;
arranging for the import, packaging, shipping labeling, and
distribution of drugs and other investigational supplies to
and from the clinical trial sites as appropriate to the
study design; arranging for the central collection of
laboratory specimens from clinical trial sites; extracting
data from clinical trial records including electronic
healthcare records, making any and all filings required by
the food and drug administration as well as the ema for
observational research, and as appropriate investigational
new drugs; preparing statistical reports resulting from
clinical trials an studies
41
Training clinical trial site personnel concerning protocol
requirements and the use of tests and rating systems for
such protocol; training clinical trial site personnel in the
use of medical and research equipment and procedures
required by protocols
42
Pharmaceutical research services; pharmaceutical research
and development; technical writing of clinical report forms
for others which are required by clinical trial study
protocols; technical writing of clinical trial reports for
others; database development services to process data
collected from clinical trials
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