Nagarro works with pharmaceutical companies to help them implement validated systems for their Research and Development groups. Nagarro has worked with both clinical and non-clinical groups to implement applications for data warehousing, reporting, LIMS system integration and submission management. Apart from extensive experience with FDA-mandated procedures, Nagarro is registered with the European Medicines Agency for implementing electronic regulatory submissions using emerging standards such as PIM.
Summary
Nagarro can help R&D department in major Pharmaceutical companies in the following areas:
- Solutions to accelerate time to market through end-to-end data integration, automating business process workflows and interdepartmental knowledge management
- Tools to help manage regulatory and compliance procedures
- Submission / eSubmission applications
- Clinical and non-clinical data aggregation / data warehousing solutions using an in-depth knowledge of LIMS systems such as Provantis, PathData, TFR/Tox, Waters, Thermo, InnaPhase and others
- Reporting and statistical analysis such as Kruskal-Wallis, Fisher’s, Dunnett’s, Levene’s, Welsh t-test etc.
Regulatory Submission Management
Nagarro can help build back-end applications for data warehousing and reporting to help generate data driven content for the Common Technical Document (CTD). Typically this data needs to be generated from numerous heterogeneous data models supported by the underlying laboratory systems. The data needs to be properly correlated, statistically analyzed, tabulated, annotated and made available in various formats. All this needs to be done using validated systems that comply with 21 CFR Part 11 and other regulatory requirements. Nagarro understands these challenges and also the structure of the underlying data schemas so as to develop these applications effectively.