SDTM mapping is the standardised process for collecting and compiling data that is needed when undertaking clinical trials. It is used by pharmaceutical companies, medical companies and food companies to compile and submit all the necessary data to regulatory bodies that then make the decision of whether or not the drug or food product goes to market.
SDTM Mapping is Changing
The SDTM process is historically regarded as a long and drawn-out affair that cost a lot of money, time and resources. But this is no longer the case. Now there are smart new methods that can automate this process and make it faster and easier to gather and compile these essential data sets. Medical software companies have made smart automation programs that can drastically cut down the time and costs involved with this crucial part of clinical trials and food testing.
Clinical Trials Are Extremely Costly
The clinical trial process is a very long one. It will usually take around 10 to 15 years and consists of 3 or 4 main stages with pre-trial processes also involved. The costs involved to take a drug all the way through all stages of clinical development can cost anywhere from $10 million up to $100 million. This will often involve several versions of the drug that is being developed, that will eventually be reduced down to a handful by the time the trials are finished. This small selection of drugs is then submitted alongside the SDTM datasets, and the regulatory bodies will have the final say as to which drug will end up on the market.
SDTM Automation Can Streamline This Process
By automating the process of collecting all the data that the clinical trials produce, there are vast time and money savings to be had by medical companies. The automation process can manage the data right from the outset, from study set up to submission for consideration. Often medical companies report that the data sets compiled using this specialised software exceed the standards required by regulators such as the FDA and NCI. Since the automation tool will flag up issues with the data entered, no double-checking is needed as the data will always be compliant.
All The Data In One Centralised Place
One of the biggest advantages of using a data automation tool is that is places all your data in one centralised place. It has clever search tools to find, review and manage all your content, and you can do this across different platforms. It comes ready to go out the box, and can even set up sub-data to do with the trails themselves that wont actually be submitted.
Effortless Integration With Automation Software
These pieces of software can import and export data into other data sets and data management software, making it easy to switch over and get started with easy SDTM management. It allows many different collaborators and users to access the data from anywhere in the world, which has huge benefits for medical companies that are working on a global scale.