Data Standards Development

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Samvit team members have been actively participating in the Clinical Data Interchange Standards Consortium (CDISC) and the HL7 Standards Development Organization (SDO) for the past eight years. Our focus and expertise are in the semantics and content of the CDISC and HL7 data exchange standards in relationship to the clinical research and clinical trials domain. We have extensive experience in the following clinical research data standards:

HL7 v3 Standards:

    • Study Participation message
    • Study Design message

CDISC Standards:

    • Study Data Tabulation Model (SDTM)
    • Clinical Data Acquisition Standards Harmonization (CDASH)
    • Biomedical Research Integrated Domain Group (BRIDG) Model
    • Study Design Model (SDM-XML)

Samvit Solutions is the only CDISC authorized BRIDG trainer. We provide BRIDG training at all CDISC Interchanges in the US as well as internationally. To learn more about the CDISC BRIDG Deep Dive training course, please visit http://www.cdisc.org/content3273.

      • As CDISC trainer, we provide in-house BRIDG training to large Pharmaceutical companies and consulting services for BRIDG implementations.
      • Our expertise with CDISC SDTM, SDM, CDASH and BRIDG standards allows us to participate and contribute effectively to the development of data exchange standards in support of the new Coalition for Accelerating Standards and Therapies (CFAST) initiatives in Therapeutic Areas.

 

CDISC Education

KEY PROJECTS

Biospecimen and Biobanking Vocabulary Development

BRIDG Model