Data & Biostatistics
EDC Design & Build
Translate protocol requirements into structured electronic data capture that supports clean, analyzable and traceable study data.
When This Service Is Needed
Needed before study start-up, once the protocol and case report form requirements are defined and a database must be built and validated.
How Bioexcel Approaches the Requirement
Bioexcel translates protocol endpoints into an eCRF specification, builds edit checks and role-based access, then runs UAT before the database goes live.
Scope of Support
What Bioexcel Provides
eCRF specificationEdit checksRole-based accessQuery workflowUATData exportsDatabase lock support
Key Deliverables
- eCRF specification
- Validated database
- UAT report
- Data export files
Data / Regulatory Interfaces
Feeds directly into clinical data management, biostatistics and the clinical study report.
Typical Engagement Model
Full-Service PartnershipFunctional Service ProviderProject-Based SupportConsulting & Advisory
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