Requriements Analysis & System Modeling
As analysts, we envision our role primarily as a communication bridge between all project stakeholders:
- We communicate directly with project sponsors and subject matter experts to solicit and document their business needs;
- We analyze the business needs and develop detailed technical requirements that can be consumed by the development team;
- We work with Project managers to accurately communicate the requirements with the developers, and subsequently verify the implementation of such requirements;
- We support QA engineers and testers in validating test cases



Data Standards Development
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)