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AstraZeneca successfully migrates clinical data and meets regulatory requirements with SAS®

When AstraZeneca UK, a major hub of the global pharmaceutical company, needed to migrate clinical data – its most valuable asset – from one old system to a new one, any disruptions in data processes, any accidents during the transition, any delays – even one day – could have cost the company millions of pounds. AstraZeneca UK had to ensure that the data would be transferred into the new environment quickly, accurately and in full compliance with the 21 CFR Part 11 regulations. The solution, based on SAS/Warehouse Administrator and underpinned by the SAS Intelligence Architecture, did exactly that.

In late 2002, the immediate challenge facing the company was migrating data from a soon-to-be-decommissioned database into its replacement, while ensuring that a complete audit trail of all transactions was in place to meet regulatory requirements. "We actually had to migrate from two clinical data entry systems, which fed into two disparate RDBMS databases, into a common format: a new Oracle-based RDBMS," explains Paul Frost, applications development leader, Clinical Information Management at AstraZeneca UK. "Introducing a new clinical RDBMS obviously has an impact on ongoing trials, and the time frame of trials means that decommissioning will almost always involve migrating data from one RDBMS to another."

The solution – comprising SAS/Warehouse Administrator, the SAS Intelligence Architecture to ease deployment and related SAS technologies to support regulatory compliance – meant AstraZeneca was able to create and manage a highly controlled migration process, including the all-important audit trail, which covered updates, deletions and insertions. "This gives the reassurance required by both AstraZeneca and the regulatory bodies we report to," says Frost.

SAS/Warehouse Administrator managed and documented the migration process; this involved exporting data from the legacy system to SAS data sets, which effectively formed the source data. This data is then used in conjunction with the new data collected in the replacement RDBMS. The data also had to integrate with other systems created for validation and reporting, which meant output structures had to be well-defined. "Through a single point of control, SAS/Warehouse Administrator enables you to manage complex data integration processes. It manages the metadata used throughout, supporting impact analysis and providing the audit trails you need." The SAS approach combined best practice with a consistent structure in the architecture. Moreover, the additional tools developed by SAS UK, based on its position as a center of excellence in data warehousing, covered areas such as configuration, job administration and password-protected audit. All of this contributed to faster deployment, easier scheduling of jobs and easier maintainability. AstraZeneca has a global three-year agreement with SAS and knew from previous experience that all solutions involved in the migration project would come with full validation credentials and high levels of support, including ongoing support for future SAS versions. Another important consideration was SAS/Warehouse Administrator's ability to control data processes across a number of platforms, which meant inherent future-proofing.

"All pharmaceutical companies want to bring drugs to market as quickly and safely as possible," explains Frost. "We'd have real problems getting anything to market if we didn't have SAS integrated into our environment. It's the de facto tool at the majority of AstraZeneca R&D sites for clinical and pre-clinical analysis. Certainly, any submission to a regulatory authority would automatically be SAS-driven." For some years, AstraZeneca has made extensive use of SAS in clinical analysis as well as in financials and product strategy.

"Based on our experience with SAS since 1977, we had the confidence it could deliver what we needed in the time frame," continues Frost. As expected, implementation was smooth. "It took three months from the first meeting with SAS to the first prototype study build. SAS Consultancy services took only 19 days and came in on time and within budget."

Standards and Speed
Batch load times were reduced by using automated job submission and parallel job flows. At the same time, an intuitive configuration management interface allowed easy migration from development-to-test-to-production environments with full version control. This approach helps when creating similar study structures, a useful feature for organizations that must address various standards for safety data. Development of all projects is underpinned by a common infrastructure, which reduces installation and maintenance overheads.

"The greatest strengths of SAS are its analytics and data manipulation," adds Frost. "With SAS already used for data extraction, we're exploring how other SAS solutions can add value to the business. For example, looking at CDISC data standards. This involves examining output standards and technical solutions across AstraZeneca as well as looking at both XML and generic data standards. We've defined our standards and are identifying how we can take them towards CDISC3 (i.e., the Submission Data Model) compliance. We've got two choices, based on our extraction tool that operates on the Oracle database and creates SAS data sets: We can either modify that to fit different data standards or use SAS to do the transformation within SAS. We're now looking at SAS®9. With its XML mapping tool and additional functionality, I think SAS®9 will make a big difference for AstraZeneca."

About AstraZeneca
Employing 54,000 people worldwide, AstraZeneca is focused on providing prescription medicines that "make a real difference for patients" in key areas that include cancer, cardiovascular, central nervous system, gastrointestinal, infection, pain control, and respiratory and inflammation. It manufactures in 20 countries and markets products in more than 100. In the UK, the company employs 10,000 people and operates eight principal sites, including an R&D center of excellence at Alderley Park in Cheshire.

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