SAS CLINICAL Training is Statistical Analysis System / Software it was developed North Carolina State University and mainly for the agricultural Purposes, during 1966-1976 it was developed. Mainly used for this Advanced Analytics, Business Intelligence, Data Management and Predictive Analytics. And later during 1980-1990 further, the developed by Adding New statistical procedures Additional Components and Introduction of JMP. SAS Clinical Training is variety of software tools and packages available across the globe; among these SAS CLINICAL is classified data management tool and also a statistical tool.
SAS is used for the data management and also for Statistical analysis, so data management or data warehouse is nothing but it is used for reporting and ETL process, that is extract transform unload if you take Cognos and Tableau these are the reporting tools but they can’t perform the ETL are Statistical Analysis. Similarly DataStage and Informatica they can naturally perform ETL process but neither reporting, not the statistical analysis, there are many other many statistical packages available like SPSS, Quantum, Statistica and R. so these can perform only statistical analysis but they not using reporting and ETL task. But SAS is the one which can perform all these 3 tasks that is nothing but ETL and Statistical analysis. That is the reason why SAS is becoming one outstanding analytical across the globe.
It is used in various industries like Healthcare and pharmacy, Financial Service, Retail, and Telecom sector also it is used. Now see how SAS Clinical Training is useful to each industry if you take clinical sector SAS is mainly used in clinical crimes to perform Statistical analysis like calculating descriptive statistics like mean, standard deviation, medium values like that.
Let’s take a small example here in clinical trials so many subjects are involved, so for each subject, several visits will be scheduled to take their values, for Bp or some time to take blood samples like this. So there are many visits’ finally we will take one value either that is an average or minimum value or the maximum value depending on the requirement, Clinical SAS Programming Training is easy to deal with large data SAS is being used.
A SAS Clinical training trial or clinical research is nothing but a study conducted on a new drug before releasing that into a market, To start a clinical trial what are the required things initially, first, there should be a Sponsor and with him, he should have some new drug or new medicine anything. If he wants to release the new drug into the market he has to go to the FBA and get to an approval from FBA, as a having on new drug he cannot directly releasing into the market, when he approaches FBA, FBA will equation him why should I approve your drug, think that his new drug cure for the deck, then FBA will question him already market in so many drugs why should I again approve your drug. Then sponsor has to prove FBA that his drug is more efficient than the already existed drug. Think suppose already existed one curing the-deck in 5 hrs old one, but this new drug has to cure within 5 hrs or it should take 5 hrs then only FBA will approve. If it is taking more than 5 hrs then there is no use to releasing into the market. So sponsor has to prove his drug efficacy that it is more efficient than the already existing drug and also it should not contain side effects. Only acceptable side effects should be there, so for that he has to do some trail research process he has to conduct some study, they required some set of people will call them a subject, as it is new drug we don’t and whether it will give side effects or not, if it is giving again who will treat them. In general, if we are getting any abnormality decision to whom will go, will go to the doctors. So he required some doctors also will call the investigators. Like this, some set of people are required. Let see step by step
Investigator selection based on his drug also it is mandatory right based on specialty the drug is about the unique drug.
Patient recruitment they recruit healthy people and unhealthily people if the drug is to test about side effects are how the drug is working. Some side effects may get because of that cancer also, they recruit only cancer patients then according to study that study for the drug there are more side effects which are not true.
Data entry & validations in this team data entry persons and also data managers will enter the data they enter on paper and CRF. Again this case report form is different type one is paper CRF and another one is electronic CRF, nowadays we are not using paper CRFs, we may not say that each CRF will contain only one page or two pages, it depends on the study. If it is containing 50 pages those many patients how many pages it will take and they should not miss every single page also, the without missing single page they have sent it to FBA. So directly data entry persons will enter there and then they will convert into database.eCRF is looks like a paper but the format will be the same but in our system says the software will be installed, so directly data entry persons will enter there and then they will convert into the database. Nowadays they directly enter into a database that is called electronic data capture, it can take as this is database it has a large number of data. If you enter more data into your excel it will get hang it won’t open soon. But EDC it can take a large number of data, and also we have to maintain this data confidentially that security is very important. So using this EDC we can secure or data and it is very safe also.it can be accessible anywhere in the world and they having sponsor website details and internet connection they can log in anywhere.
Data managers this manager they will validate the data, whatever the data entered by data entry persons they will validate this data, why because they may not enter data correctly, so this data manager they will do validation by Edit checks.
The statistician will have own document called SAP means statistician analysis plan, so in this plan based on the protocol, everything will be mention what kind of reports SAS programer hs to developed. So SAS programmers to generate different kinds of reports.
Medical writing team this medical writing person they will write a report, and again they submit to a statistician. Finally, this statistician will create CSR (Clinical study report), this re will submit the FDA it depends on the sponsor requirement; he wants to get the approval he will submit to FBA.
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