A top 40 pharmaceutical company enhanced data access and decision support for pre-clinical safety with Certara’s D360 data access and analysis application and a specialized CDISC SEND-based database.
Pre-clinical scientists at a top 40 pharmaceutical company faced delays of a day or more for data collation and transformation with each incremental data update received from their Contract Research Organizations (CROs). Data arriving in spreadsheets or PDF study reports needed to be merged, copied, pasted and formatted for analysis and presentation—a time-consuming and error-prone process. The increasing use of CDISC® SEND (Standard for Exchange of Nonclinical Data), while a richer data format, posed additional data manipulation issues. Further, inconsistent terminology in use across CROs and studies complicated data preparation. The requirement for manual data preparation delayed decisions on adjustment or continuation of on-going studies, while the nomenclature differences made it nearly impossible to compare and analyze data across different studies.
The delayed availability of new information impacted study monitoring, slowed learning about candidate drugs, and delayed critical early development decisions. In addition to problems in monitoring on-going studies, responding to FDA and project team questions proved especially challenging, requiring tedious adjustments to resolve inconsistent field names and units before trends across studies could be evaluated for potential biomarkers and deeper scientific understanding.