Clinical Data Management

Rigorous oversight and management of your clinical data is our focus. Beaufort’s highly proficient data management team provides the expertise to maximize data quality and transparency, maintain data integrity and security, and quickly identify and correct issues to help ensure you are audit-ready.

Our methodology is predicated on early involvement in all key phases: regulatory strategy, protocol development, and design and alignment of the data collection with the product claims.  Working with our team from the start enables a strategic advantage and improves overall trial efficiency. Our data management systems are 21 CFR Part 11 compliant and user-friendly — which is ideal for all types of study programs.

We Adapt to You

Beaufort can provide full-service integrated solutions specifically tailored to your project or augment your staff to support a stand-alone need. Our experts will help accelerate your decision making and keep your trial on track.

End-to-End Solutions

We offer a full complement of services from protocol development through database lock and transfer, including:

Design

  • Data management plan preparation
  • eCRF development (CDISC)
  • Database design
  • Edit check development
  • EDC build
  • User Acceptance Testing (UAT) and validation
  • On-time database “Go Live” for FPI (First Patient In)

Site Support

  • Database user training
  • Site support and training
  • Data review listing development

Study Execution

  • Post-production changes
  • Query resolution
  • Data review and cleaning
  • Data entry
  • Study progress reporting
  • Data quality analysis and feedback
  • Database lock
  • Data transfer

Ready to get started? Contact us today.