Pharmacovigilance & Drug Safety

For applications in drug safety data analysis, Waban Drug Safety Solutions includes data marts for the integration of drug safety data, clinical trial safety data and public-domain post marketing data. Safety data records are transformed into an analytic database suitable for generating hypotheses based on relationships between drugs and events. The templates and data transformations for data cleaning and merging included in Waban DSS can be customized to meet the specific needs of a particular installation.

The system provides researchers with an analytic data repository and associated tools required to maintain a drug safety database to assess safety of compounds that are already in the market and those in the drug-development pipeline. The system also provides a summary dash-board view for the drug-safety officer that provides information about all adverse event issues with currently active drug trials. The system comes prebuilt with analysis views that will automatically run standard analysis on the adverse event data to highlight issues with the collected adverse events data. This reduces the review time significantly and requires fewer review-query-analyze iterations. This enables drug-safety groups to handle larger number of AE and SAE reports by taking away the mundane tasks and allowing the team members to focus on value-added activities.