I know what you’re thinking here: who’s Adam and what does he have to do with food? Well the answer is ADAM is not a person, it actually refers to a process called the Analysis Data Model, and SDTM stands for Study Data Tabulation Model.
ADAM SDTM are a part of the standard structure for compiling human clinical trials and food product approval. These dataset formats are a requirement in the field of testing drugs and food, and most big regulators like the FDA require mandatory submission of all the data that is accumulated in the testing phases in ADAM and SDTM format.
So What Goes Into These ADAM SDTM Datasets?
There are a number of variables that have to be submitted alongside final food and drug submissions in the form of ADAM SDTM datasets. The main ones are:
Identifier variables: these identify the study, the subject, the domain and the sequence
Topic variables: these specify the focus of the observation
Timing variables: these outline the timing of the observation
Qualifier variables: these include additional text, values and traits relevant to the observation
What’s the Problem?
The main issue with these datasets and all the data that has to be entered is the time it takes to compile it all ready for submission. If we take human clinical drug trials as an example, this process can take years to complete. A full 4 stage clinic trial process for a new drug can usually take anywhere from 10 to 15 years to complete. This is a big timeframe, with lots of money being thrown at it along the way. So anything that can be done to speed this process us can save food and drug companies not just time, but also vast sums of money.
What can ADAM SDTM Dataset Software Do?
ADAM SDTM automation is making this whole process quicker and easier, with the potential to shave years off of the clinical trial process in the case of drug trials. The earlier you can start compiling the datasets, the easier it is to get the drugs through the clinical trial process. It helps cut down on delays down the line, where time and money can quickly add up to astronomical figures. Automation software means no programming, no manual data input, and most importantly it minimises errors that could cause delays in your application approval.
How They Work
Usually, ADAM STDM automation software comes with templates to get you started. From there you can add domains and variables and tailor them exactly how you need them. As you continue to data and information, you are always able to preview the data as it will look to the reviewers, which is valuable as it gives you insights as to how well it will perform under scrutiny. The software is also smart, meaning that it can make recommendations based on the data already logged, as well and suggestions for headings and columns. Ultimately the main advantage is that there is no programming needed, it is all taken care by the software itself.
