Samvit’s Role in Multiple Healthcare IT Projects

BRIDG Model

At Samvit Solutions, our analysts are the primary modelers and designers behind the Biomedical Research Integrated Domain Model (BRIDG). These UML class diagrams represent the details of protocol-driven research, showcasing our deep understanding and expertise in the clinical trials domain. The BRIDG model is a collaborative effort to create an industry-standard representation of clinical research semantics and is supported by several stakeholders – NCI, CDISC, FDA, HL7, and ISO. Samvit analysts provide support to BRIDG users from pharmaceutical organizations, CROs, and some software vendors. Samvit analysts have worked closely with CDISC over the years and mapped CDISC standards such as SDTM and CDASH to BRIDG and incorporated those requirements into the BRIDG model. Samvit’s analysts worked closely with CDISC leadership and were instrumental in making BRIDG an international standard represented in ISO/IEC 14199 information Models.

Samvit Solutions was the first and only CDISC-authorized BRIDG trainer. We provided BRIDG training at all CDISC Interchanges in the US and internationally.

https://bridgmodel.nci.nih.gov/

Our team’s extensive experience developing clinical research software solutions over 15 years has honed our deep domain knowledge. Samvit’s team has worked closely with CDISC, HL7, and several other NCI projects over the years to build consensus and represent the clinical research requirements in this single-domain information model. This long-term modeling effort allowed us to learn in depth the complexity of the domain and the intricate processes of clinical trials at cancer centers, regulatory requirements that must be supported by the pharmaceutical companies in the submission of clinical trial data to regulatory bodies, etc.

 

Clinical Trials Reporting Program (CTRP)

Samvit analysts played a critical role in the Clinical Trials Reporting Program (CTRP), a strategic initiative for the National Cancer Institute (NCI). As the lead analysts and data architects for over 10 years, we drove all facets of business and technical analysis, data and process modeling, and design for the CTRP system and its reporting database. Our extensive interactions with stakeholders to gather, analyze, and transform business requirements into implementable technical specifications exemplify our strong capability to perform research and develop an in-depth understanding of requirements. Samvit analysts worked with the stakeholders from each data source stream to CTRP systems to define the data exchange requirements and work with the end user cancer centers and protocol abstractors to collect feedback. Our responsibility in designing the database and data warehouse models underscores our proficiency in meeting sophisticated reporting needs. This experience has provided us with extensive practical skills in NLM’s ClinicalTrials.gov trial registration processes.

 

Biospecimen and Biobanking Vocabulary Development

The National Cancer Institute’s (NCI) Biorepository and Biospecimen Research (BBRB) initiated an effort to standardize and develop meta-data standards in support of consistent and standard data exchange to enable semantic interoperability. The focus was on developing the common data elements and supporting vocabulary for the Cancer Human Biobank (caHUB) EVS to provide standardization of data elements/concepts and associated vocabulary/terminology bindings to the wide variety of data types (e.g., clinical data on patients, specimen “life cycle” data, quality management data, molecular analysis data) collected from a wide variety of sources (e.g. medical research centers, university hospitals, health care institutions, pathology resource center) to enable data sharing and provide consistent interpretations of the research data during data analysis. Samvit team leveraged our analysis and standards development expertise to spearhead metadata standardization in this critical biospecimen and biobanking domain. We worked extensively with domain experts from BBRB and the biobanking community and leveraged the existing work from public ontologies to develop common data elements and vocabulary for the GTEx and BPV programs. These data elements were eventually registered in the NCI caDSR and the NIH CDE repositories. This enterprise-level endeavor in vocabulary development utilizes established standard terminologies such as CPT, the National Drug Code list, and ICD10, enriched by domain expert-defined value sets. Our approach in this project exemplifies our capacity for understanding complex terminology systems and our commitment to enhancing precision and clarity in the biobanking domain.