CONTEXT

Our client possessed a number of excellent Programmers and Statisticians possessing a strong understanding of legacy data standards. However, they lacked solid experience in CDISC standards with in depth knowledge of SDTM, ADaM and ODM and approached us with this problem.

RESOLUTION

We provided consultants who thoroughly understood the client’s standards in place in order to unravel the legacy formatted data. Then, following the CDISC guidelines, they created SDTM mapping of the data across the project in preparation for submission and future integrations. During this period, our team built a plan for logical mapping from legacy data to standard SDTM domains while creating SDTM domain for various studies within timeline.

RESULT

Working with the client’s internal team members, our professionals mapped the entire project level data from legacy format into a STDM following CDISC guidelines. The consistent and accurate mapping of the SDTM which led to ease in creating define.xml justified the ROI. The time savings due to our efforts here led to successful integrations, increase in productivity and efficiency throughout.