B&D Life Sciences - CRO

Life Sciences 

CDISC Legacy Data Conversion


CDISC data standardization facilitates clinical data pooling, standard reporting, and data transfers with partners.

Additional important reasons for converting legacy (or on-ongoing) clinical study data into a CDISC format are :
- To comply with the Food and Drug administration (FDA) submission requirements
- To prepare clinical data into a data warehouse ready format to maximize its usability

CDISC legacy data conversion process

The FDA has embraced the CDISC SDTM and CRT-DDS as the standard data model for submitting tabulation data in an electronic format. FDA reviewers are requesting sponsors to use the SDTM model to vastly improve their review efficiency and accuracy. The Business & Decision Life Sciences data conversion process uses established techniques for converting clinical study data to the CDISC SDTM and metadata (define.xml) format for regulatory submission. The analysis datasets can also be prepared into ADaM format.

Data warehouse preparation

Sponsors are realizing the added value of a global data standard across all systems and processes. Study data and metadata are typically supplied by third party providers, and the data may currently exist in different, non-compatible formats.

To maximize the usability and value of existing data, Business & Decision Life Sciences helps sponsors to convert all existing data into a data warehouse-ready, CDISC standard structure.

Benefits

  • Maximizes the value of clinical study data; a key asset of clinical research
  • Reduces CDISC legacy data conversion cycle times and cost
  • Avoids investing substantial development, programming and validation efforts by outsourcing the CDISC legacy data conversions, including :
    • preparation of CRF annotations, SDTM and ADaM datasets
    • generation of metadata (define.xml and define.pdf)
    • development of a data reviewers' guide
    • preparation of trial design domains
  • Avoids delays in NDA submissions. The CDISC SDTM datasets and corresponding define.xml are evaluated on their CDISC compliance, resulting in an NDA submission that will successfully load into the Janus data warehouse.

© 2008, 2009, 2010Businness and Decision All rights reserved

Accessibility | legal notice | Contact | sitemap | RSS