Drug Safety 2007; 30 (10): 919-990 0114-5916/07/0010-0919/$44.95/0
ABSTRACTS
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Poster Presentations P.133 Quality PV in a Cost-Conscious Environment – Innovative & Practical Applications of PV Data in a Medium-Sized Pharma Company R. Gordon,1 W. Smedley2 1 Cephalon Inc., Frazer, Pennsylvania, USA; 2 Shire, Chesterbrook, Pennsylvania, USA The flow of data through the drug development process often travels a circuitous route. There usually exists the necessity to create a bridge between the end user s needs and the data capabilities. To facilitate more efficient PV surveillance, various data sets must be collected, normalised, and delivered to permit ease of approach and analysis. The ability to retrieve and securely access central database information using common analysis tools is a cost-effective way to optimise usage of transactional information in a PV environment. The capability of standard desktop computer software allows for the integration and interpretation of this data. The foundation of this particular safety surveillance function focuses on the use of desktop software to retrieve, store, and query essential database information. The data can then be retrieved by collaboration of the data interpreter and the analyzer at various junctures along the query process. Utilizing macros created from platform standard tools effectively minimises the output and maximises usability and productivity. The development of specialised search strategies facilitate the analysis. With the refinement of the search criteria greater specificity achieved. Surveillance can then focus on the identified event(s) of interest and their clinical weight as a single case or part of a case series, in the identification of a possible signal. A review of this signal detection process from its manual beginning to current automated state will be presented along with benefits of delivering database records to multiple sources. This emphasises the dynamic interaction between technology and output which facilitates quality maximisation through minimization of effort.
