BioPier Products - Clinical Data Safety

Feature Highlights

• Unlimited views and filters can be configured on adverse event datasets for reuse and sharing amongst team-members. This allows members of different function to see the subset of their interests. When any adverse event data is displayed, the other available views are always available as pull-down list at top-right corner for user selection.
• Unlimited edit-check and validation rules can be configured on adverse event datasets. Edit-check and validation rules can be directly applied to adverse data listing to display rule exceptions. Those rule exceptions may be configured to be color-coded. The records of rule exceptions may be exported to Excel spreadsheet, PDF, or saved as a view for future reuse.
• Pre-configured adverse events summary by SOC (Body System), preferred terms, and/or lower terms;
• Any legacy AE datasets can be mapped to Clinical Workbench™ to utilize instant AE summary features. You can import SAS datasets, or a CSV file which is generated by a supplied SAS program;
• Three-Levels of Adverse event summary granularity:
  • By SOC (Body System) only
  • SOC (Body System) and preferred terms
  • SOC (Body System), preferred term and lower terms
• One-click to summary swap between the "number of subjects" summary to "occurrences of adverse events" summary.
• Pre-configured adverse event summary by severity or causality with built-in rules that only the most severe or related adverse event is counted for the same adverse event.
• Numbers of the adverse event summary (either by "occurrences" or by "number of subjects) is built with URLs. When you click a number with URL, the corresponding raw data listing of that specific subset will be displayed for your validation.
• Can dynamically apply filters to AE summary or listings to select corresponding sestet. For example, views may be configurable to select serious AEs, or specific any subset value(s) from AE table or dimensional tables.
• Can dynamically apply grouping to AE summary using dimension from AE, demographics or any derived table (like key-VAR). Such grouping allows you to display AE summary by any arms of your interest. For example, you may summarize AE by age group, site, race, baseline disease severity, etc.
• AE summary output can be saved as EXCEL spreadsheet, or PDF file for read-only distribution. The URL of a table view can be sent by email for collaborative view by team members.
• Configured summary view definition can be saved on AE dataset for future use.
• A saved summary or listing view may be set to "Private", "Shared", and/or "Default View". If set to "Private", the view is only visible to the originator. A "Shared" view will be visible to all team members. Any "Shared" view (either summary view or listing view) may be set as "Default View" (Subject to access control). When a data is opened without a view specified, the default view is used.
• Configuration steps are saved in its history file, which allows you to replay and revert to previous.
• Corresponding SAS coding can be generated automatically for a given table summary and data listing.