GELSUS RESEARCH & CONSULTING, INC. Trademark

Pharmaceutical research and consulting services related to clinical studies and trials, namely, study monitoring of phases I-IV such as site selection, investigator recruitment, CRA and regional CRS recruitment, and status and enrollment; clinical data management and analysis, namely, case report form design, database design, protocol design, clinical plan development, and statistical support and analysis; conducting safety evaluations and reports, namely, statistically analyzing data obtained from clinical trials and adverse event reports and preparing reports regarding conclusions reached; preparing reports pursuant to Centre Internationale Office de Medicale Surveillence criteria and Food and Drug Administration regulatory affairs such as IND/NDA preparation; serving as a liaison to regulatory agencies regarding clinical studies; technical medical writing for physicians and scientists in the area of obesity, gasteroenterology, allergy endocrinology, internal medicine and hypertension; expert witness services in the fields clinical pharmacy and clinical pharmacology