CDISC Implementation and Submission

LLX’s key employees have excellent CDISC experience. CDISC data standards are rapidly becoming industry standard and adopted in various phases of clinical research. With our experience we can help your company make standards implementation seamless.

CDISC Advantages

CDISC has developed a set of data standards to enhance data collection, management, analysis, and reporting efficiencies, improve safety monitoring, and streamline the review and approval process for investigational treatments. Under the ICH’s electronic Common Technical Document (eCTD) guidance, CDISC Study Data Tabulation Model (SDTM) is the preferred standard for content format and structure of clinical data for all clinical studies. Based on proposed federal regulations, the FDA will mandate that all clinical trial submissions be in electronic format and that the content comply with data standards guidance. LLX helps our clients by not only implementing these standards on a project or program, but also by providing our clients with an understanding of the CDISC standards.

CDISC Expertise

LLX’s is able to provide expert services to our clients for successful standards adoption  paper-based clinical trials and eCRFs for electronic data capture (EDC) clinical trials following Clinical Data Acquisition Standards Harmonization (CDASH) compliant.  LLX key members leverage their years of experience in statistical analysis and strategic consulting to provide SDTM mapping and Analysis Data Model (ADaM) data for statistical analysis in support of ISS and ISE.

LLX provides the following CDISC services:

  • CDASH Compliant CRF (Paper or Electronic)
  • CDASH and SDTM Annotated CRF
  • SDTM Mapping
  • ADaM Data
  • Generation of Define.xml and Define.pdf as well as related Documents for submission
  • Metadata and Data Repositories
  • Strategic Consulting
  • Comprehensive QC of SDTM/Metadata following CDISC SDTM 3.1.2, 3.1.3, 3.2