Life Science Software – Drug Research & Development

A (Quantitative) Structure-Activity Relationship (Q)SAR result needs context before it can support a regulatory conclusion.

For mutagenicity assessment under ICH M7, one part of that context is the applicability domain (AD): whether the query compound is sufficiently represented by the chemistry used to develop the ...

For many quality and compliance teams, a regulatory inspection triggers a familiar and disruptive pattern. Skilled personnel find themselves pulled away from their usual responsibilities to search for the correct version of a file, compile audit trails from multiple disconnected systems, and reconstruct chains of custody from email threads and memory. This kind of preparation...

In clinical trial transparency, the terminology used in processes and reports is critical and can have significant downstream regulatory effects. The language used in an anonymization report influences how reviewers understand the strategy, how consistently teams apply it, and how easily a disclosure package can be adapted for another market.

Protected personal data...

Thornton & Ross Ltd was struggling to organize and collate large, diverse, and increasing volumes of laboratory test data to the point that these volumes were overwhelming their existing workflows. As the UK’s largest pharmaceutical manufacturer, it was imperative that they find a Laboratory Information Management System (LIMS) capable of keeping up with its compl...

The Energy Innovation Center is part of WMG at the University of Warwick and conducts high-volume Lithium-ion battery testing for hybrid and all-electric vehicles and other high-tech battery types. The center lacked a formal data storage and management system, so it stored data in spreadsheets. This created many issues, as the center generates approximately 1 Terabyte...