Did you know that the average clinical trial process required to test a new drug’s suitability for human consumption is around 10-15 years? What about the fact that drug trials start with hundreds of different versions of the drug that they are testing, and this is cut down to just one final drug form? We often forget about the work that goes into making sure our food and drugs are suitable for human consumption. People spend years of their lives trying to discover and perfect new drugs to fight disease and help us live longer. But what can be done to speed this process up and reduce costs for food and drug companies? The answer could lie in SDTM dataset software.
SDTM Dataset Software and What it Does
SDTM stands for Study Data Tabulation Model, and refers to the global standard universal structure required for human clinical trial data, as well as other nonclinical study related data. It is the required format that must be submitted to the regulatory bodies, such as the Food and Drug Administration (FDA) in the USA. All clinical and non-clinical trail data must be compiled throughout the process and saved in one centralised database for the regulators to scrutinise and it helps them come to a decision as to whether or not the drug is suitable for the consumer market. Modern methods of coding and software development have stepped in to offer great benefits to this process, and we now have companies like Formedix who specialise in SDTM dataset software that can be of incredible value during this whole process.
Time and Money Saving Potential
Any times saving benefits are extremely valuable in this field. Since the time and money involved is already extremely high, researchers, analysts and pharmaceutical companies are desperate to make taking drugs to market as cost effective as they can. Another thing to note is that the specific clinical trial process is merely a fraction of the total costs that are involved in the whole drug development process. Some of the most expensive drug trials can cost a staggering $347 million, while the average cost for a set of trials consisting of more than 1000 patients is around $77 million. This is big money, and the while the costs can vary across the board for different drugs, the potential savings are all very similarly stacked for each trail process.
How It Works
An SDTM dataset works by providing a one click piece of automated software that takes care of everything right from the start. You can get your dataset up and running even before your trials start, getting your headings and mappings in place early on, so when the data starts rolling in, you’re all ready to go, and you can simply import it into the software. You can compare with previous studies and datasets, and even reuse the format or data itself if you are undertaking a similar study design. And all of this happens in a fully compliant way, meaning that you will never have to worry and complying with standards.
