B&D Life Sciences - CRO

Life Sciences 

CDISC integration in the Oracle Clinical/Remote Data Capture® (OC/RDC) system

Submissions of New Drug Applications (NDAs) to the Food and Drug Administration (FDA) in the US require submitting clinical study data according to the Clinical Data Interchange Standards Consortium (CDISC) standards. Currently, most of the pharmaceutical companies convert their clinical study data at the end of the clinical data management process cycle which may lead to significant NDA submission delays and increase overall cost. Upfront integration of the CDISC standards into the sponsor’s OC/RDC clinical data management system offers many advantages and is considered to be the long term solution.

CDISC (CDASH/SDTM) integration in OC/RDC

Business & Decision Life Sciences offers a number of key consultancy services for sponsors who wish to move towards a CDASH (Clinical Data Standards Harmonization)/SDTM (Study Data Tabulation model) compliant OC/RDC system. These services include :

  • Create a CDASH/SDTM compliant (e)CRF based on the study protocol
  • Develop the metadata definition
  • Create a CDASH/SDTM compliant metadata library within OC
  • Design the RDC screens and key templates
  • Prepare OC for external data uploads
  • Develop an annotated CDASH/SDTM (e)CRF in .pdf format
  • Produce SAS views based on the study specific CDASH, SDTM and non CDASH/SDTM variables
  • Install the SDTM converter routine to automaticlly generate SDTM datasets and metadata

Some additional services include :

Development of a CDISC implementation roadmap

After conducting a CDISC readiness assessment, a CDISC implementation roadmap is compiled. This roadmap includes an impact analysis at the OC/RDC level, it outlines the implementation phases and timelines, the resources required, a cost estimation, and proposed training plans.

Installation of a CDISC compliance check system

Besides the CDISC integration in the OC/RDC system, a specifically designed CDISC compliance check application can be installed to ensure the SDTM datasets and metadata generated are of excellent quality and fully compliant with the latest CDISC standards. 

Benefits

The upfront CDISC integration results in significant efficiency gains related to CDISC compliant data acquisition, aggregation, analysis and report generation.

  • There is no longer the need for converting clinical data late in the process and spend a lot of time on post-processing. As such, it reduces submission cycle times and increases the final clinical data quality.
  • This advanced solution uses identical nomenclature across the Clinical Data Management System; thereby ensuring metadata consistency and avoiding any additional data conversion steps.
  • The SDTM converter provides a generic and real-time solution; SDTM datasets can be created at the study start, which facilitates ADaM dataset generation based on SDTM, and allows for CDISC consistency checking early in the process.

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