DrugLogic® Announces Qscan®-Clinical – A Drug Safety System for Clinical Development
Product News Feb 20, 2008
DrugLogic®, Inc. has announced Qscan®-Clinical, a workflow database and analytical system that supports all phases of clinical development. Analogous to the well-known role of the FDA AERS database in Qscan®-ERM, Qscan-Clinical will include a database of marketed drug label data to assist in comparator study design and data analysis.
Clients already using Qscan-ERM with their proprietary post-market safety data will be able to extend their licenses to include the new features and databases.
Qscan-Clinical joins the expanding family of Qscan solutions and will be offered in three modes: (a) an application services provider (ASP) mode; (b) integrated with third-party clinical data solutions; and (c) integrated with proprietary pre- and post-market data systems.
Drug safety risk management in the clinical development phases of a drug’s lifecycle too often is relegated to serious adverse event (SAE) reporting and the accumulation of Development Core Safety Information (DCSI) that ultimately defines the label data.
Apart from the search for adverse events by the drug safety board, little attention is given to the emerging drug safety profile in which a particular drug may be a safety issue for only a subset of patients. Qscan-Clinical analytics can help identify situations that tailor the development of a drug to a specific population or assist in drug re-positioning efforts.
Qscan-Clinical will allow companies to monitor drug trials in real time, and begin to explore the types of genomic, proteomic and phenotypic data that are the foundation of personalized medicine. The analytic capabilities in Qscan-Clinical provide a way for companies to enter this complex area of drug development with tools that facilitate the visualization and comprehensive analysis of data found in the hundreds of millions of clinical trial data elements and SAS tables.
In addition to developing safer drugs, there is a time-to-market competitive value in fewer adverse events for so many companies that are being forced to do more with less.