SAS Drug Development with Regulatory Requirements

The latest release of SAS Drug Development is 3.0. I spoke with Chuck Reap who is a Systems Developer from SAS within the Pharmaceutical Software Analytical Solutions department. Chucked shared with me some new developments in SDD and his paper and presentation on entitled "A Regulatory Compliant Process for Developing SAS®-Based Reports".

Chuck identified some of the tasks that needed to be performed while programming SAS within a regulated industry. He then highlighted some tools that SDD delivers that fulfills these tasks. Some of these included:

• Program Editor – Enables search for logs for errors and access to SDD repository of programs.
• Schedulers – Schedule jobs
• Check-in / Check out – This is used as version control for SAS programs.
• Metadata Explorer – There is a metadata explorer to explore data and metadata.
• Electronic Signatures

Chuck was suggesting a programming environment that includes a development, test, and production to fulfill regulatory requirements. This is organized by parallel folder structure that can be managed in SDD.

The new version of SDD has improvements in the command facility. This is a scripting interface, similar to an API (Application Programmers Interface) to SDD. Although most of the access to SDD is through a web interface, some of the administrator’s tasks can be performed through the command facility to make it more efficient. The command facility is still experimental but it will be a good tool when users or administrators has to implement many studies and projects which may include hundreds of programs.