Data Standards & CDISC

For clinical data, we can provide the following consulting services in the development, implementation and management of data standards:

• CDISC implementation including
  • CDASH for data acquisition
  • SDTM for submission data model
  • ADaM for analysis data model
• Development of other standards:
  • Standard statistical analysis methodology (eg company-specific extension to RECIST for analysing solid tumour studies)
  • Standard statistical outputs (Tables, Figures and Listings)
  • Standard Clinical Study Report template (Full report and abbreviated report)

For management information and business data, data standards are equally important, and these are some of the sample services we have provided in the past on the implementation of data standards to improve efficiency:

• Data definitions to ensure each piece of data is unambigious and clear
• Database structure advice to ensure data are collected in a useable format
• Data validation rules to check the validity of the data
• Data analysis and reporting development to ensure the results are easily understandable and interpretable