Data Analysis

Problem

Low qualified internal resources available to manage clinical trials management system for on-going studies.

Solution

Utilized the CTS Data Management System to generate counts, listing reports for Clinical Study Report (CSR) by Treatment Groups. Assigned 9 person team to specialized therapies areas and other criteria. A10 performed data analysis and validation using queries and patient viewer. Special focus on generating ad-hoc reports that calculate the instances of safety, efficacy, and demographic parameters for randomized and non-randomized patients. Created specifications for standard and protocol specific SAS transport files, performing UAT tests to insure correct output consistent with FDA requests. Generated and validated Item 11 deliverables for submission to FDA which included producing data definitions and annotated CRF documents. Responsible for processing of Item 12 deliverables including eCRF components which reflects clinical and demographic data analysis. Updated standard reports grid according to data management plan in order to specify the parameters that must be applied to counts and listings reports and SAS transport files.