Data Standards Development

Data and metadata standards establish a common understanding of the meaning or semantics of the data. They define concepts’ structure, format, and meaning and identify a common controlled terminology when applicable.

Data standards are essential to enable seamless interoperability between systems. There are many types of data standards in the context of biomedical research and healthcare.  Samvit team has developed extensive knowledge and expertise in a large set of healthcare data standards and have successfully cross-mapped many of these established standards as well as leveraged UMLS and NCI Metathesaurus.

When data standards are implemented and preserved in an organization, they become the common thread in the entire data lifecycle – from data collection at the source to enabling data aggregation, sharing, and re-use. The development of consensus-based data standards can be a complex process involving subject matter experts for the given sub-domain of healthcare and many different stakeholders, such as Standard Development Organizations (SDOs), terminology/ontology governance teams, end users of the data standards like the research institutes, software vendor community, pharmaceutical industry, etc.

Samvit is an active participant in both HL7 FHIR and CDISC data exchange SDOs, which empowers us to stay at the cutting edge of these exchange standards. This expertise allows us to effectively guide our clients in these sectors to integrate and leverage these standards, enhancing their data management and interchange processes.

Samvit Solutions’ team of analysts has supported several initiatives at the NIH and the US FDA to help develop consensus-based data standards with supporting terminologies. Our deep expertise in several biomedical data standards and industry-established terminologies and ontologies, combined with our ability to research and learn new domains quickly, allows Samvit to bring that insight and expertise to data standards development efforts at the organizational level.

Our involvement in these specialized areas, from clinical trials to pharmaceutical quality, showcases our ability to tailor data interchange standards to the unique needs of each domain. By partnering with us, clinical research, cancer trials, drug labeling, and pharmaceutical quality clients gain a dedicated ally skilled in developing and implementing compliant, efficient, and transformative data standards and data exchange solutions.

Samvit Solutions has been an Organizational GOLD Member of HL7 since 2015.  We participate actively in various HL7 Work groups and our CEO has served as co-chair for 4.5 years of the Biomedical Research & Regulation (BR&R) Work group.