Data & Biostatistics

EDC Design & Build

Translate protocol requirements into structured electronic data capture that supports clean, analyzable and traceable study data.

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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
HIPAA Compliant
ICH-GCP Compliant
FDA 21 CFR Part 11
ISO 9001
ISO 14155
ISO 27001 Certified
EU MDR 2017/745
EU IVDR 2017/746
US FDA Requirements
ISO 20916

Discuss Your EDC Design & Build Requirement

Share your program details and Bioexcel can help scope the right level of support.