Clinical and Pre-clinical Data Management with Databricks Platform

This document is a technical report on Hexaware's Clinical Data as a Service (CDaaS) solution, which aims to transform clinical and preclinical development processes for cell and gene therapy, precision medicine, and other areas. It outlines the capabilities of CDaaS, emphasizing its generative AI tool known as the clinical co-pilot, which assists clinical professionals in complex tasks and enhances access to sophisticated clinical insights. The report details how CDaaS integrates with various data sources and streamlines the creation of essential documents such as Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Standard for Exchange of Nonclinical Data (SEND). Key features include comprehensive data integration, efficient standardization, advanced analytics, and the provision of therapeutic area-specific packages. The document also highlights the advantages of a unified platform and automated workflows, which collectively accelerate data preparation and standardization, ultimately facilitating better decision-making and improving patient safety.