Study Data Tabulation Model or SDTM for short, is currently the standard format for compiling and submitting the data that is collected during clinical and non clinical studies. It is a requirement when applying for approval of any new food product or medicinal drug. These datasets are then submitted to regulatory bodies such as the United States Food and Drug Administration or FDA, who then examine the evidence and make an executive decision as to whether or not it can go to market for human consumption.
Clinical Trial Process and SDTM Mapping
Any drug that is being put forward for approval amongst human users must first undergo several phases of clinical trials. A standard set of clinical trails has 3 stages, known as phase 1, 2 and 3. Some trials do have an earlier stage known as stage 0, and some even have a 4th phase. The entire process can take anywhere from 10 to 15 plus years, and can some trials can cost up to 200 million dollars. This amount of time and money is a huge amount, however it is necessary in order to get these drugs to market. However, anything that can be done to make this process faster and easier for the researchers involved is hugely valuable. This is where SDTM mapping software from companies like Formedix come in.
Food Trials Process
The food trial process is quite different from the exhaustive clinical trial process that drugs have to go through. However, they are more often than not submitted to the same regulatory body, such as the FDA. Furthermore, they are submitted in the same format as an SDTM dataset for approval by the regulators. While drug trial focus on the effectiveness of the drug being tested amongst real human participants, food trails are different, in that they mainly test for the nutritional content and ingredients for labelling purposes.
What Can SDTM Mapping Do?
SDTM mapping software can take weeks off the time it takes to complete one clinical trial phase. Companies often refer to it as ‘one click set up’ for all clinical trials and food testing submission data. The software essentially automates the process of entering data into the SDTM dataset, which can save time and prevent delays in the future. It uses ready made templates to make setting them up and getting them going fast and easy. In addition to speeding everything up, it also helps to minimise errors in the data that can often be picked up along the way.
One major benefit of using automation software is the fact that you can have datasets premade ahead of the data collection. This means that data can then be imported from a study in a single action, and the data will be compiled into one central database. It will catch errors and can even make suggestions and learn from previous studies so that it works with you as you go. If you are involved in food or drug testing and have not heard of SDTM mapping, you need to look into it now.