The Chennai based Kinship Technologies Private Ltd has launched a new product called iDERT (Integrated Data Extraction and Reporting Tool) which will enable Pharmaceutical and Biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products.
The company is the leading Bio-statistical Analysis and Clinical Data Standards Organization with product development capabilities, has focused itself strategically into pharma industry with drug discovery as its core area of operations.
The new software product is being used by Pharmaceutical and Clinical Research Organizations in the USA for their internal operational needs, said BG Giri, general manger of the company. Giri, who is an expert in Systems management and application of statistical techniques in analysis of clinical trial data, said the company is planning to showcase the product in the Annual DIA Conference in Boston next Month.
"The iDERT is an integrated tool to serve the biostatistical and reporting team within the Clinical Research Department of a Pharmaceutical organization. It brings an integrated approach by assisting the biostatistical team to extract the trial data captured in various Electronic data capture tools such as Oracle clinical; Excel based solutions to SAS environment using SAS Macros. This extracted data is used for biostatistical Analysis within the tool", the general manager explained.
According to the scientists of the company, the software solution 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.
"It 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 view, transform, analyze and report data across clinical applications, and across projects or trials within the same environment and in a regulatory compliant manner", they pointed out.
This is achieved in iDERT by extracting data from various sources that are prevalent for a study and creating a fully controlled, traceable, complete GCP and 21 CFR Part 11 compliant data for various modules that are integrated in the product.
The iDERT, which is identified as the flagship product of the company, is designed to meet the needs of clinical research personnel - such as data managers, bio-statisticians, programmers, regulatory affairs, etc. - involved in the integration, management, analysis and reporting of clinical trial data and align with the organization process standards, Giri told Pharmabiz.
It is easy to use and improve the productivity and the validation effort is zero. Other important features are version controlled and validated environment, deploy skilled resource for exploratory analysis and regulatory compliant.
The company possesses the state of the art infrastructure for its services and product development work at its Chennai facility. It has a set of Standard SOPs for Pharmaceuticals and Biopharmaceuticals in area of clinical operations, data management, IT, Bio-statistics and Submissions.