Description: 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, management and compilation of information in the field of clinical trials for business purposes, namely, surveys, retrospective chart review, prospective longitudinal cohort studies, post approval safety studies (pass), registries, and interventional studies for approved and investigational drugs; Business management services, namely, 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, all for business purposes | 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 | 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
