Study Data Tabulation Model (SDTM) defines a standard structure for human clinical trial (study) data tabulations and for non-clinical study data tabulations.
In the last few years, complex data interchange industry standards – like SDTM standards – have evolved considerably and will continue to evolve, making them essential to be at the top of the latest versions. Although the new version of SDTM standards claims to be backward compatible, it is not always the case. The reason behind this is that the organizations have been using custom domains for a long time, where SDTM standards fall short. Hence it is now an absolute necessity for organizations to work with SDTM implementers and mapping partners who can bring the right amount of knowledge, people, and automation technologies tool together.
Clinical Data Integration (CDI) is a process of mapping and organizing clinical data in SDTM compliant format. Many pharmaceutical companies and CROs find and treat each CDI activity for each trial uniquely, further requiring them to employ extensive manual coding and multi-step processes with little automation. Organizations have recognized that the SDTM programmers with knowledge of SAS® products, particularly their CDI solution – SAS Clinical Standard Toolkit as well as SAS ISO 8601 can do the job of mapping the data to SDTM datasets faster. Deploying an army of qualified and experienced SDTM and SAS programmers can significantly cut down the time it takes to map complex study datasets with multiple domains and range of data sources.
United States regulatory authority of Food and Drug Administration (FDA) has mandated SDTM as the standard specification for submitting tabulation data for both clinical and non-clinical studies. As a result, detailed understanding of SDTM standards, structures, domains, and variables is essential for all clinical and non-clinical data managers in order to develop datasets to be approved by FDA. Using SDTM standards helps speed up the reviewing processes of trial data by biostatisticians, medical writers, and regulatory reviewers. These efficiencies translate to lesser revenue leakage or delays in realizing the revenue.
What makes Technosoft’s solution one-of-a-kind is their exhaustive experience of the processes involved in delivering efficiently and cost-effectively by using their global delivery model. Their SDTM and SAS experts are regularly in touch with their customers’ team.
With this access to customer knowledge centres, they analyze Study Protocol, Annotate Case Report forms (CRFs) (based on the protocol), each study’s time and events’ schedule, Architecture Loader Sheet (ALS), Subject Visit Templates, Organization/Sponsor’s Data Coding guidelines, and IVR/IRT/RTMS specifications data. Mapping rules created by these experts are then validated by their Quality Experts who are located in the offshore delivery centers. Further the validation process ensures that the mapping rules meet the implementation guidelines. In the end, the errors are fixed with the help of offshore SDTM mappers.
Final mapping is then used in the appropriate ETL tool to create the SDTM dataset ready for ingestion in the subsequent downstream processes. With stringent SLAs around each and every step and with 24x7 delivery services, Technosoft’s SDTM mapping service provides customers a repeatable, consistent, and cost-effective solution.