A regulatory application to automate and streamline part of the Common Technical Document (CTD) creation process was developed by Nagarro to help a global pharmaceutical company better manage and produce CTDs, while complying with FDA 21 CFR Part 11. As a result the company was able to efficiently generate and manage non-clinical study tables, while complying with European, Japanese, and U.S. regulations.

Problem Description

Prior to working with Nagarro, the drug safety group at a global pharmaceutical company was able to generate study level tables for non-clinical studies, but its process of using a combination of semi-automated and manual processes lacked efficiency and was not FDA 21 CFR Part 11 compliant. The company needed a validated system that could expedite the generation of drug safety evaluation study tables and tabular project summaries while meeting International Conference on Harmonization (ICH) and FDA requirements. This required devising a tamper proof process that could produce standardized documents.

Solution

Specific features of the system include:

•  Data extraction from multiple geographically diverse and separate LIMS systems 
•  Specialized adapters to allow communication with LIMS system using varying languages 
•  Periodic synchronization with LIMS systems 
•  Statistical analysis for study level data performed using SAS 
•  Output made available as SAS datasets, XML format, or PDF format 
•  Centralized data warehouse 
•  Generation of ‘canned’ reports, as well as user configurable reports

Benefits

• Enabled client to be FDA 21 CFR Part 11 compliant 
• Followed harmonized approach as outlined by the ICH Steering Committee 
• Reduced time required for FDA submission process, as well as potentially quicker product releases as a result of refined process and accuracy of system 
• Allowed scientists to generate data tables and monitor internal progress of studies on demand 
• Ability to integrate into new LIMS systems, generate new types of reports, and conduct new types of analyses 
• Flexibility of style sheets allow formatting to change if needed 
• Use of XML data in subsequent eCTD generation