CDISC Services

MakroCare's Data Submission Standards team provides expert services to our clients for successful standards adoption in every phase of development. This specilized team will ensure that your legacy study data and data from ongoing trials are migrated to submission-ready, fully CDISC-compliant SDTM data.

We design Clinical Data Acquisition Standards Harmonization (CDASH) compliant CRFs for paper-based clinical trials and eCRFs for electronic data capture (EDC) clinical trials, allowing us to provide our clients with SDTM compliant data in every phase of development.

MakroCare leverages its years of experience in statistical analysis and strategic consulting to provide CDISC-compliant Analysis Data Model (ADaM) data for statistical analysis in support of Integrated Summaries of Safety and Efficacy.

Services
  • CDASH Compliant Case Report Forms (Paper and Electronic)
  • Gap Analysis of Study Documents and Data
  • CDASH and SDTM Annotated Case Report Forms
  • SDTM & ADaM Compliant Data
  • Integration of Controled Terminilogy (CDISC and Sponsor-Defined)
  • Generation of Define.xml Utilities and Define.pdf Documents
  • Metadata and Data Repositories
  • Strategic consultancy
MakroCare approach to CDISC
  • Follow FDA Submission Guidelines
  • Define basic safety metadata standards to guide dataset organization - not rigid structures
  • Allow flexibility for therapeutic area and sponsor differences
  • Develop a library for therapeutic areas over time
  • Develop standards and follow the process as per the CDISC development

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