Services Provided
Management of preclinical and clinical trials (i.e., study design, feasibility, evaluation, large-scale data collection through cutting -edge IT/IS, analysis, and interpretation).
Evaluation of product pipelines for pre- and post-market launch through clinical data stratification (i.e., adverse events, health outcomes, pharmacoeconomics, cost-of-illness, cost-effectiveness) through comparison with alternative treatment modalities.
Management and evaluation of pharmacokinetic (PK) and pharmacodynamic (PD) drug profiles via compartmentalized and non-compartmentalized analysis.
Regulatory support concerning investigational new devices (IND), new drug applications (NDA), PLA, pharmaceutical manufacturer's application (PMA), integrated summary of safety (ISS) and efficacy (ISE), and NDS submissions.
Database management and statistical analysis (via SAS (6.12, 7.0), SPSS, Access, Excel, and WinNonlin).
Peer-reviewed publication processing for health care professionals of all disciplines encompassing medical/scientific report writing, data presentation, graphical illustrations, literature reviews, journal selection, and targeted audience. Also, includes monographs, training manuals, and drug utilization evaluation criteria.
Development of slide kit modules for specific disease state management.
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