What does SAS stand for in clinical research?
Statistical Analysis System
Statistical Analysis System, or SAS, has been the industry standard for data management and
analytics of large volumes of data. It's a very flexible platform that provides users various
means to manipulate, analyze, process, and report on data.
What is SAS Used for?
Imagine AstraZeneca managing the production, provenance, current location, destination, or
pharmacy customer for every pill produced. Imagine Lufthansa managing the air tickets and flight
data for millions of customers every day. Or perhaps Honda tracking the inventory for every
vehicle produced and for sale around the world – plus data on which parts are included in which
models at any given location; in case of a product recall? These are all examples of things that
can be done with SAS. AstraZeneca, Lufthansa, and Honda are all companies that use SAS in their
everyday business. SAS is an invaluable tool for business in the 21st century.
Why Clinical SAS Analytics
With the increasing demand for medicines, there is a building pressure of pharmaceutical
research and development and using computational tools is automating many of these processes and
making them more efficient. Clinical Research is one such growing industry that requires trained
specialists in Bio-IT.
How sas is used in clinical trials
The Role of SAS in Clinical Research and Clinical Trial Management. Statistical Analysis System,
or SAS, has been the industry standard for data management and analytics of large volumes of
data. It's a very flexible platform that provides users various means to manipulate, analyze,
process, and report on data.
SAS Application in Clinical Trials
FDA defines clinical trials as voluntary research studies conducted in people, that are designed
to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other
therapies, or new ways of using existing treatments. The data generated is the most important
and confidential to a clinical trial project as the fate of the drug, whether or not the drug
will reach the pharmacy shelf, depends on it. A clinical trial is conducted in multiple centers
and a large amount of data is generated which can be difficult to manage. Once the data is
clean, a clinical study report should be written for submitting to regulatory authorities for
product approval. Statistical Analysis Software (SAS) is a bio statistical tool used to manage
and generate tables, listings and graphs for clinical study reports etc. Let’s discuss the
basics of the SAS tool and its use in clinical domain.
SAS is a multi-domain application used to generate reports, tables, listings, 2D and 3D graphs,
charts, etc. The major domains of SAS are SAS®/Clinical, SAS®/Finance, SAS®/Banking,
SAS®/Advanced Analytics, SPSS®/Market Research, Excel/Analytics, Minitab etc. In clinical
domain, SAS plays a major role in data analysis and thus in preparing the clinical study report.
SAS environment has three windows namely, editor window, log window and output window. The
editor window is used to write and execute the SAS program. The log window displays the backend
execution of the program and error messages. The output window displays the output of the
executed program. Every statement in SAS ends with semicolon, “;”.
The core functions of SAS in clinical trials include:
• Protocol Design and Study Start-Up
• Patient and Investigator Recruitment
• Clinical Trial Management
• Clinical Data Management
• Data Analysis
• Clinical Supplies
• Regulatory and Safety compliance
• Regulatory submissions
SAS play a major role starting from defining the clinical study to till regulatory submission.
SAS can be integrated with the clinical trial management systems (CTMS) like Oracle Clinical.
The data integration process starts with the extraction of data (Data Importing). Once the data
is imported to SAS environment, the data is filtered and data cleaning takes place. Once the
data is clean (error free), SAS tables are generated for analysis of the data. The clinical
study report is compiled using data generated in the SAS environment. SAS also plays a role in
protocol development, randomization process, IVRS/IWRS procedure, CRF designing, adverse event
reporting etc.
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