Research data sources software suit which is used to manage the data, to visualise the data and analyse the data. SAS is Very powerful tool in the management, analysis and visualisation of data. So many Competitors for science like R, Python, SPSS, Informatica SQL, etc. But among all those, SAS has around 36% of total job openings when compared to all other competitors like our SQL economy as well. SAS Is widely used in financial sector and clinical sector as well. There are many other competitors for size and financial sector like R Python etc. There is no other competitive process till date. So, sizes most widely used software in analysing the clinical trial data in the clinical sector. So before going to tell you what is meant by clinical trial, let me give a brief introduction about the product development process. To get into the market, it should pass through the experimental phases and then it should come to the market so that the data acquired from the experimental process is put into the SAS software and is analysed, and this as software is used to convert our data into the standards that are required by the regulatory authorities. The process for any of the molecule there are different phases in the drug development process. It starts where the experiments in the laboratory on the animals which are also called US preclinical studies or Preclinical Research. Once the drug molecule has passed through this Preclinical Research, the pharmaceutical companies will file IND application to the regulatory authorities like FDA. If that regulatory authority has approved the IND application of the pharmaceutical company, then the drug will be moved towards the clinical trial to the clinical research where the drug will be desperate focus on Safety and effectiveness in human beings.
Here there are different pages in the clinical research phase zero. Phase One, phase two, phase three and phase four. Phase zero is also called as micro dosing studies which will be connected to decide the dose. Phase One is convicted in a small group of healthy warranties to decide the safety of the drug in. Phase two is the conductor in around 100 participants to decide effectiveness of the drug and phase three of the clinical research is conducted in large Population in order to compare the drug effectiveness with the drug which is already there in the market and once this phase is completed, the pharmaceutical company should file new drug application or any application to the FDA. If the FDA approves this NDA application, then the drug can be released into the market.
See science is useful in the drug development process right from the stage of Preclinical Research towards stays over the post marketing surveillance that is the full phase four of clinical research. it can analyse your experimental data and it can say you whether the drug is really effective or not. It is also useful in submitting your findings to the regulatory authorities like USFDA. See, everything we communicate with the SAS will be in the form of a SAS program, any software. Is a combination of steps step. How exactly is this clinical science useful in the real time and what is the real time workflow in a pharmaceutical industry or in CRF programme a success? Developers say you will be getting the clinical research. This year in the form of paper or electronic format policy RF that is case report form. That data from the case report form is called as raw data. This raw data it will be sent to the pharmaceutical company where the SAS programmer is working and this SAS programmers work is now to convert. This round, the other information from the CRF, if that is the case, report form into a standardised SDTM data set which is approved by FDA regulatory authority. So, FDA authority has set some standard guidelines to analyse the clinical trial data. Each and every programmer should adapt to these guidelines and prepare their clinical trial data as per the SDTM and Adam guidelines approved by FDA. And these guidelines were prepared by an organization called as CDISC is nothing but clinical. Interchange standards consortium that means this organization is allowing us to change our clinical trial data into a standard format that can be easily readable by the regulatory authorities. SDTM data set will be converted into an ADAM data set that is also called as analysis data model by using certain rock steps and these analysis data sets will be further. To generate report scoreless tables, listings and figures who should be together submitted to USFDA. in order to get an approval for the drug you’re working on from the regulatory bodies like FDA. Not only that one there are many other regulatory authorities like European Medicines Agency. Almost all the regulatory authorities will have some standard for match like this and 80% of the global regulatory authorities are accepting CDISC SDTM Adam Standards for regulatory clinical trial data submission. The clinical trial data will be coming into the pharmaceutical. Industry in the form of raw data sets, which will then be converted by a SAS programmer into a standardised SDTM data set. These SDTM data sets will then be converted into ADAM data sets, and the report’s data visualisation will be done in the form of tables listings of figures, which will then be submitted altogether to the regulatory authorities. So, this is all about the size and how and where write the SAS programming code in clinical research side and what is a real time workflow of person and how to write the science programme. Thank you.
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