SAS (Statistical Analysis System) is widely utilized in clinical trial data analysis in pharmaceutical, biotech, and clinical research companies. The utilization of SAS in clinical researches has given unbelievable results in past years. SAS helps healthcare professionals to meet their business goals, generate great revenue, enhance strategic performance management and most importantly control costs. The healthcare industry is one of the most important industries in India when it comes to health welfare.
According to HIMSS Analytics and Dimensional Insights survey, 84% of healthcare organizations are using data analytics tools for decision- making for strategic planning. According to the report of FICCI (Federation of Indian Chamber of Commerce and Industry), “India is the largest provider of generic drugs globally. Indian pharmaceutical sector industry supplies over 50% of global demand for various vaccines, 40% of generic demand in the US and 25% of all the medicine in the UK. Presently over 80% of the antiretroviral drugs used globally to combat AVAILS (Acquired Immune Deficiency Syndrome) is supplied by Indian pharmaceutical firms.”
The Role of SAS Data Analytics in Healthcare: The major role of SAS in Pharma Analytics mainly focusses on generating the TLF’s or TLG’s. The CDISC standards like SDTM and ADAM which are used to standardize and to analyze the clinical trial data and the generation of reports can be only done by using Clinical SAS since FDA accepts only SAS reports. The department of BIO- Statistics is using clinical SAS for writing the SDTM and ADAM specifications and in the creation of SAP (Statistical Analysis Plan). CDM team is using SAS to perform data analysis before loading the data into certain databases. Analysis with clean data and validating the clinical trial data will reduce the pain on the FDA to have a good overview of the clinical reports. Hence most of CROs are preferring clinical SAS as the best tool to use for its safety and efficiency when compared with other software tools.
Why we need SAS Data Analytics in Healthcare? Clinical data is sensitive information that should be treated as an asset as well as a regulated commodity. Not only can improper management of clinical data cause the invalidation of an entire clinical trial, but it may also result in strict remedies, including serious financial penalties, from the FDA. At the time of this writing, the FDA has not issued revised CFR 21 guidance. This indicates that the FDA is still struggling with the difficult issues and requirements compliance for a clinical database. However, it is known that the FDA does request that all clinical DBMS prevent unauthorized access to data. This requires that data be password protected and allow updates only by authorized users of the clinical DBMS. The FDA also requires the maintenance of complete audit trails for clinical data. Both the entry and revision of clinical data is to be logged to indicate the user performing the action, the date and time of the action, as well as the reason for the change of data. These requirements and many others are all easy goals when working with the SAS System.
In addition to being easy to use, SAS is also the choice of the FDA for receiving and reviewing clinical data. The FDA is still requesting SAS transport data sets as the standard for receiving electronically submitted data. At a minimum, each FDA reviewer is equipped with the SAS System Viewer. Since the use of SAS is essential to clinical information management, keeping clinical data in SAS makes sense. Reporting is also effectively accomplished using SAS.
There is no doubt that the SAS Data Analytics tool has transformed the healthcare sector along with other sectors in India. In the healthcare sector, there are immense career opportunities for pharma background peoples, having SAS skill. Learn Clinical SAS with Sankhyana (SAS Accredited Centre), we are the best sas training institute in bangalore.
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Reach us: +91 8017768006, arvind.kumar@sankhyana.com, www.sankhyana.com
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