Clients

Case Study 7
For a top ten pharmaceutical company

Challenge
Automate Study Report Table generation to reduce the time required to prepare report tables as well as ensure detail accuracy and format consistency.

Solution
  • Develop centralized data mart for study data sourced from Provantis, PathData, and TFR/Tox LIMS systems
  • Develop GLP / 21 CFR Part 11 compliant system for Study Report Table generation in report ready PDF format and in alternate formats such as CSV, SAS Transport and XML
  • Harmonize toxicology data to serve as a data source in future Drug Safety Data Warehouse and create Data Table formats that are consistent across DSE sites and across functional areas
  • Customize enhanced statistical procedures for use in Study Report Table generation
  • Permit import and use of CRO data for Study Report Table generation, in later stages
  • Standardize procedures for facilitating the efficiency of operations for data summarization and presentation

Result
Enabled submission ready reporting to comply with GLP and 21 CFR Part 11 - The automated process reduces required time from the drug project leader and staff, accelerates data compilation and analysis, improves accuracy and data quality, and speeds the completion of IND, NDA submissions, and other regulatory filings. The data mart can be browsed using standard analytical tools and serves as a validated and consolidated data source for the Drug Safety Data warehouse. Enable reporting from a common interface for current DSE LIMS systems independent of any specific underlying LIMS system. Client funded a second phase which is currently underway to add additional data sources and produce eCTD and SEND compliant output formats.



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