Case Studies

Samvit Solutions’ Role in the FDA’s PQ/CMC Project
The core objectives of the FDA’s Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC) Project are twofold. First, to develop structured data standards for the PQ/CMC domain, and second, to create a data exchange standard for submitting this...

Samvit Solutions’ Involvement in the NCI Data Standards Services (DSS) Project
NCI Cancer Research Data Commons (CRDC) CRDC is a cloud-based data science infrastructure for sharing, integrating, and analyzing data from cancer research. It enables NCI-funded programs to publicly share their data in genomics, proteomics, imaging, and other data...

Samvit Solutions Involvement in Transforming FDA’s Data Exchange Standard for Product Labeling
Samvit Solutions embarked on a transformative project with the FDA, focusing on evaluating the possibility of replacing the existing Structured Product Labeling (SPL) data submission standard. The current standard, based on the complex and challenging HL7 V3, has been...

Samvit Solutions’ Role in the Code Map Services Project
The Code Map Services project, involving multiple HHS agencies, aims to enhance interoperability in patient-centered outcomes research (PCOR) using real-world data by building on a prior project to harmonize different Common Data Models (CDMs). The Code Map Services...

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...