Data science and technology aligned for your study’s success
Clean, consistent, and validated data is central to every successful IVD regulatory submission. Beaufort understands this critical necessity and applies a data-centric approach to your clinical research program. Our data sciences team leverages decades of data management expertise to maximize your data quality and transparency, maintain data integrity and security, and quickly identify and correct issues to help ensure your IVD study is audit-ready.
Our comprehensive approach and methodology can be deployed across all key phases — regulatory strategy, protocol development, and design and alignment of the data collection with product claims — to greatly improve efficiency in your data processes across the entire trial. Working with our team from the start enables a strategic advantage and improves overall trial efficiency. Our systems are 21 CFR Part 11 compliant and user-friendly — ideal for all types of programs.
Data Management Solutions
- Data management plan preparation
- Electronic Case Report Form (eCRF) development (CDISC)
- Database design
- Edit check development
- Electronic data capture (EDC) build
- User Acceptance Testing (UAT) and validation
- On-time database “Go Live” for First Patient In (FPI)
- Database user training
- Site training and support
- Site query entry/generation
- Post-production changes
- Query resolution
- Data review and cleaning
- Data entry
- Study progress reporting
- Database lock
- Data transfer
Data science integration to maximize performance
Our data sciences team is composed of biostatisticians who are skilled at translating your data into actionable insights, and will work hand-in-hand to support your team from protocol development through final analysis and reporting.