Case Study: Pharmaceutical – Exploratory Development, Clinical Trial Phase 2 and 3 Studies

Clinical Trials - Pharmaceutical Company in the US

The Business Challenge/Situation

The client required an offshore team to create analysis datasets, data listings and tables for presentation for reporting of clinical data for Exploratory Development studies, phase II and III studies. In depth knowledge of BASE SAS (8.02) was a criteria to create reports that agree with the FDA (Food and Drug Administration, USA) standard guidelines.

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Market Equations Role

Market Equations reviewed the quality of raw data, created the analysis dataset from raw data, created the safety and efficacy reports, and validation of those reports. On average almost 15 raw datasets were provided and we created almost 20-25 analysis datasets. Volume of the analysis datasets varied from 1,000 to 10,000. All the reports and datasets were made using SAS. BASE-SAS is used for creation of analysis datasets and safety reports. Procedures like PROC SORT, PROC FREQ, PROC FORMAT, PROC MEANS, PROC REPORT were used in the process. BASE-SAS and SAS-STAT were used for the creation of reports

Client Impact:

The off-shore formula made a huge impact to the client’s bottom line through productivity gains and significant differences in resource costs.

ME maintain a fantastic relationship with the company and representatives are always eager to provide their references whenever required.

Explore how the Market Equations Consultative Approach to decision making works wonders.