We have done hands-on conversions including define.xml and using validation tools/packages. Therapeutic exposures: Cardiovascular, Women’s Health, Neurosciences, Oncology, Respiratory, Vaccines, and Hypertension.
We verified top line results by comparing and reconciling analyses of CDISC-based approach vs. RAW Data-based approach for quality assurance.
Our CDISC conversions included legacy and ongoing studies with 100% hands-on macro programming, including SDTM and ADaM data sets.
We directed CDISC data standards pilot project with hands-on programming all modules.
As a standards consultant, we performed thorough and independent reviews of a third party’s CDISC conversions and ADaM derivations and communicated comments and suggestions that improved the overall quality and deliverables.
We implemented data standards by engaging and working with multiple function groups and stake holders that resulted in consistent and prompt access to clinical and medical information for biostatistics, data management, safety, and scientific publication.
We’re familiar with oncology domains such as TU, TR, and RS; and lesion-based measurements for solid tumors (RECIST Criteria); performed survival analysis, response analysis (CR/PR/SD/PD), and QoL.