SDTM ADAM Datasets Essential For Food And Drugs

SDTM ADAM Datasets Essential For Food And Drugs

For those of you who don’t work in clinical testing or food production, you probably won’t have a clue what SDTM ADAM even is.  You may not realise that it is quickly becoming one of the most important pieces of software around today. 

Before any drug even gets close to being available to the public, it has to go through rigorous testing and jump through many hoops to even be considered for public use.  The same story goes for food products, although it is no where near as extensive as the process for pharmaceuticals, they still have to adhere to strict rules and meet the criteria.  This process for either area is a long and drawn-out affair, with the average drug being approved in a staggering 15 year time period, and the average food product taking around 3 years to be approved.  This is where SDTM ADAM automation software comes in.


SDTM ADAM Automation Software

SDTM and ADAM software are essentially two different types of software that drastically speed up the timeframe in which drug and food products can be approved.  SDTM actually refers to the standard form of data logging for food and drug trials.  Pharmaceutical companies and food manufacturers all over the world have to submit stacks of data compiled into standardised formats, the most common of which is the SDTM format.



SDTM stands for Study Data Tabulation Model, and is the standard structure for human clinical trial data, as well as nonclinical data such as food data.  ADAM is short for Analysis Data Model and is essentially the connection between the SDTM datasets and the final statistical analyses.  They are both so widely used that they have become the standard models across most of the world. 


Data Eats Up Time And Money

Take a standard clinical trial procedure for a pharmaceutical drug.  As previously mentioned, this process is lengthy and has been known to take up 20 years for some complex drugs.  Within this 20 year clinical trial time frame, the average amount spent getting the drug to the final stage is $20 million, and that is only the money spent on the trial phase.  One the highest ever estimated amounts spent on a single drug trial period was $347 million.  These numbers show the full extent of the money involved in this process, and gives an insight into why new ways are emerging to try to reduce costs for companies trying to get drugs to market.


Huge Cost Saving Potential with SDTM Automation Software

SDTM software alone can severely reduce the time and money spent during the clinical trial process.  It streamlines the data entry process as well as speeding up the whole data complication process.  This means it can get the data ready quickly for the approval stage of clinical trials.  The ADAM software bridges the gap between the SDTM hard data and the final end result statistics.  Even just taking a year off of the clinical trial process could potentially save a company millions.