DrugLogic®, Inc. an established provider of post-market drug safety analytic and data solutions, today 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 an easy 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.
"We are excited to be able to offer a solution that integrates pre- and post-market data, public as well as proprietary data, and extend the drug safety warehouse of knowledge to a vast array of information often buried in pre-launch data, noted Dr. Colette Saccomanno, DrugLogic's Director of Client Research. "Companies will no longer need to juggle three, four, or five different analysis systems and maintain various databases to understand the safety profile of a drug from development, to launch, to Phase IV studies, and beyond. What we offer is an easily tailored process - including a ˜starter set' workflow - that will allow researchers to fully evaluate incoming data, make timely adaptive clinical trial design modifications, plan better active comparator trials, and review real life experience in medical practice. To our knowledge, this is the first system that integrates clinical trial data with workflow and analytics that includes all the standard frequency table proportionalities and Bayesian statistics.
Qscan-Clinical builds on the Qscan family of products and adds three key components:
- PROCESS MANAGEMENT: a multi-site and multi-workflow system that can parallel process multiple databases. The system maintains a full audit trail for regulatory compliance.
- COMPREHENSIVE, INTEGRATED SAFETY DATA: a set of quantified label and listedness information, available only as text in product information, translated and mapped for integration and comparison with both clinical trial data as well as post-launch spontaneous reports.
- PROPRIETARY ANALYTICS: a ˜differencing engine' that can be used for multi-arm comparisons and for application of techniques such as statistical control charting.
Qscan-Clinical is available now for pilot programs in an ASP mode, and will be available for client site installations by the end of Q1 2008.
About DrugLogic®, Inc.
DrugLogic®, Inc. specializes in developing analytical tools and enterprise process support systems for managing risks related to drug safety issues. DrugLogic designs, develops and delivers products that provide the latest innovations and state-of-the art solutions in support of pharmacovigilance and drug safety surveillance practices for both pharmaceutical and biotech companies. Its proprietary Qscan® product monitors both company proprietary adverse event data and publicly available data sources. For more information, visit www.druglogic.com.
