“Integrated Data Extraction & Reporting Tool (iDERT™)is an outcome of integrating clinical and non clinical data from multiple sources into a single environment where it can be standardized, analyzed, visualized and reported on by clinical researchers to regulatory agencies in shorter span of time from last observation last visit.
iDERT™ brings a complete set of process automation using the implementation of Clinical Meta Data Repository model across different stages of clinical development by enabling the user to extract, view, transform, analyze and report data across clinical applications, and across projects or trials in different therapeutics within the same environment and in a regulatory compliant manner. This is achieved in iDERT™ by extracting data from various sources that are available for a study and creating a fully controlled, traceable, full GCP and 21 CFR Part 11 compliant data for various analysis & within modules that are integrated in the product.
iDERT™ is designed to meet the needs of clinical research personnel - such as clinical data managers, biostatisticians, programmers, regulatory affairs, project managers etc. - involved in the integration, management, analysis and reporting of clinical trial data and align with the organization’s process standards.“
The broad spectrum of clinical research processes is outlined below, which is part of different modules in iDERT™. |