Product Summary
BioPier Clinical Workbench is a clinical data repository system, a powerful team-based data review and analysis platform
What is Clinical Workbench?
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Team-based clinical data review
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Clinical data validation
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Clinical safety and statistical analysis
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Integrated patient profiling
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Integrated study document viewing
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Clinical statistical reporting (CSR) automation and standardization
Who are Clinical Workbench Users?
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Biopharma companies: Utilize the system as a centralized data repository (CDR), allowing the clinical team to review and validate study data, and monitor clinical trial safety
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CRO or EDC companies: Provide their clients the strong value-added data reporting and analytical services
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End Users: The entire clinical team can review ongoing study data, analyze safety signals and efficacy outcomes, view patient profiles, play what-if scenarios, and collaborate reports and overall findings, etc.
What Data Format can Clinical Workbench Accept?
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Data from all EDC vendors such Medidata Rave; Both paper and EDC trials;
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Accept both legacy and CDISC SDTM format. Configuration-free reporting and analysis for CDISC SDTM data.
Key Features
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Web-based Application:
No installation needed
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Integrated Interface:
All study formation are organized together for a general audience, no programming knowledge is required;
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Reports Sharing:
Data listing views can be easily configured, and shared amongst clinical team members, or kept just for personal use;
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SAS Program Automation:
Data listing views can be exported into the corresponding SAS programs to produce traditional paper-trail listings;
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Built-in Clinical Intelligence:
In-depth common domain exploratory analysis from key safety signals such as adverse events, laboratory, ECG, Vital Signs. Longitudinal, drill-down and sub-group analysis
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Domain-Mapping Technology:
Out-of-box reporting and patient profiling for SDTM data; For legacy data, the system provides the domain mapping technology.
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Strong Visualization:
Summary statistics and patient profiles are visualized;
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Data Drill-down:
Summary statistics can be drilled down to detailed subject data listing;
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Integrated Patient Profiles:
Can be viewed from a known subject or from any data listing view;
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Data Transfer Friendly:
The same study allows multiple data transfers and is able to report schema and data differences;
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Easy Edit-Checks:
Edit-checks can be easily defined to highlight data issues;
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Strong Access Control:
Role-based access/visibility control to compound, study level and report level.
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Study Documents Viewing:
Study documents such as Protocol and SAP can be viewed with the study data.
Video:How it Works?