Enterprise Modeling (BRIDG, LS DAM, and BAM)
Samvit analysts are the modelers for the Biomedical Research Integrated Domain Model (BRIDG) and the Life Sciences Domain Analysis Model (LS DAM). These models are UML class diagrams that represent the data semantics of the protocol-driven research and the life sciences domains. The BRIDG model is collaborative effort engaging four stakeholders and their communities to build a common model representing a shared understanding of the domain of clinical research. The BRIDG model has become a de-facto industry standard for representing the semantics of clinical research. The stakeholders of the BRIDG model are the US National Cancer Institute (NCI), Clinical Data Interchange Standards Consortium (CDISC), US Food and Drug Administration (FDA) and Health Level 7(HL7).
Our analysts/modelers work collaboratively with members from CDISC, FDA and HL7 to harmonize the data semantics from various clinical research related projects and represent the data in the BRIDG model – a UML class diagram. Our analysts working experience in building clinical research related software solutions over the past 15 years have provided us with deep understanding of both the clinical research and the life sciences domains.
We have also developed the Clinical Research Business Architecture Model (BAM). The Clinical BAM captures all the activities and functions that occur at cancer centers during the planning and execution of clinical trials. These activities have been documented as UML Use Case diagrams. Samvit analysts worked extensively with the cancer center community to build consensus, facilitate discussions and collectively documented over 150 clinical research use cases that describe the processes and functions of clinical trials – from protocol authoring to study execution. Our team also worked with the subject matter experts to build detailed interoperability scenarios in support of cross-application interoperability. Details of these business scenarios were documented as UML use case diagrams and activity diagrams. We have successfully performed the role of enterprise modelers on all these initiatives for the last 6 years at a major Health and Human Services agency.
Clinical Trials Reporting Program (CTRP)
CTRP is a strategic initiative for the National Cancer Institute (NCI) which has required re-engineering many existing business processes of NCI in relation to registration of cancer clinical trials at NLM’s ClinicalTrials.gov. Samvit team members have been the lead analysts on NCI’s CTRP since its inception in 2007. We have successfully led this analysis effort and have been responsible for all business and technical analysis, modeling and design activities of the CTRP system and its reporting database. We interface extensively with all the stakeholders of CTRP to gather and analyze business requirements and build detailed implementable technical specifications for the development team. In our role as analysts on this team, we are also responsible for designing the database model and the data warehouse model in support of the reporting requirements. This experience has provided us with expertise in NLM’s ClinicalTrials.gov trial registration processes and requirements.
Biospecimen and Biobanking Vocabulary Development
Samvit leverages our analysis and standards development expertise to support the standardization of meta-data in a biospecimen & biobanking initiative. This is an enterprise level vocabulary development effort and leverages exisitng standard terminology such as CPT, National Drug Code list, ICD10 as well as domain expert defined value sets.