Enhancements and recommendations for a GCP compliant SAS environment for a mid-size biopharmaceutical company

Our client is a biopharmaceutical company in France. A few years ago we have helped them set up a new fully GCP compliant SAS environment including data storage for the storage of clinical trial data and associated information and documents. This is a SAS 9.4 environment on Windows, with a fileshare for which system access and security is managed through Active Directory.

Late last year our client asked us to support them again. Standard SAS macros used to configure the data storage and Active Directory required fixes and enhancements. Furthermore we were asked to investigate the implementation of an audit trail solution to improve their current approach to audit trailing, to help them review their existing SAS architecture and recommend long-term solutions, and finally to showcase other solutions that SAS has to offer to clients in the life sciences and pharmaceutical industry. In this article we will be focusing on the macro development and SAS solutions.

The standard SAS macros include functionality for the complete clinical trial data lifecycle: folder creation, changes, and deletion, granting and withdrawing of access, and blinding and unblinding. Functionality we’ve added includes improved audit trailing, better notifications, automated verification of double programming activities, and more detailed control over the security settings within a single clinical trial. We’ve also provided updated or new design specification documentation as well as installation and qualification scripts. During this entire process we’ve worked together with the business users as closely as possible in order to achieve maximum user satisfaction, which results in better acceptance of the tooling. These macros are now  successfully, implemented tested, and used on a daily basis to manage this GCP compliant data storage.

While a SAS 9.4 programming environment is perfectly fine for the vast majority of programming activities in clinical trials, there are other SAS solutions on the market that are worth exploring. Together with our clients we have mainly looked at the SAS Viya Platform as well as SAS Life Science Analytics Framework (SAS LSAF). SAS Viya is an industry-agnostic platform that offers a host of integration and connectivity solutions including support for programming in popular programming languages such as R, Python, Lua, or Julia. SAS Viya utilises its proprietary CAS engine to offer high-speed in-memory data analytics. SAS LSAF is a platform aimed specifically at users in the life sciences industry and offers a secure environment for data storage, statistical programming, and data analysis, and offers out-of-the-box audit trailing and versioning. Since it's hosted and managed by SAS your concerns about software validation vanish into thin air.

One of our core strenghts is the combined knowledge of the pharmaceutical industry and the implementation and management of both basic and complex SAS platforms. It allows us to support life science clients with a broad range of services from CDISC data conversion and clinical trial statistics to SAS software development and maintenance of SAS environments.