CREATING ADAM (ANALYSIS DATA MODEL) FOLLOWING SDTM STANDARDS
Compared to the SDTM, ADaM standards are more flexible and complex. We were asked to understand the client’s new project prospective analysis and in so doing, create ADaM specification standards from SDTM data in order to create TLFs’ and future integrations such as ISS/ISE.
Our Rang team was involved in the creation of the client’s ADaM project from the start and worked very closely with the stakeholders. Our team possessed the required expertise in both Statistics and ADaM along with therapeutic “know how” and a strong understanding of the various response criteria such as RECIST, Cheson, Meddra, WHO DD, and NCI CTCAE. The Rang team was the right “fit” to create ADaM specifications & datasets for our client
Through our team’s efforts and thorough capabilities in both CDISC and ADaM guidelines, our client achieved consistent implementation across the project through the creation of the ADaM from the specifications to the project level to the study level. The results led to project level consistency, time savings, ease of creating define.xml and an increase in overall company productivity/efficiency.