At Eli Lilly and Company, EWSolutions was brought in to provide strategic consulting in several areas of Lilly’s clinical trials, with the goal of improving patient protection and to streamline the entire clinical trials process (it currently takes around 10 years and over $150 million to bring a new drug to the market). This project had many facets to it.

First, it included strategic consulting on which data warehousing tools and technologies should be classified as “Recommended”, “Evolving”, and “Retiring”.

Second, assistance in designing a data warehousing architecture, with accompanying standards and processes that would be scalable and robust for Lilly’s information needs. This data warehouse needed to meet the requirement of 21 CFR part 11. This task included analyzing Lilly’s environment and data warehousing requirements, and then recommending a data architecture strategy to meet them.

Third, data stewardship guidelines and procedures were developed. This stewardship involved the key Lilly clinical data.

Fourth, interviews were conducted with the key Lilly personnel to assess the current data quality and the meta data repository requirements. Then a project scope document for the repository was created. This project scope detailed out the initial release of the repository and the future state and how Lilly was going to get there. This repository played a key role in assisting Lilly in meeting 21 CFR part 11 requirements.