UBC provides comprehensive statistical services for all phases of clinical development, with a special understanding of the unique needs of emerging companies. Our biostatistics team offers unsurpassed skill and experience in designing protocols, developing and implementing statistical methodologies and supporting regulatory submissions. In addition, UBC coordinates biostatistics, data management, SAS programming and medical writing to support clinical development from Phase I through submission.
We offer:
- Study design and protocol development
- Clinical development plans
- Endpoint selection and validation
- Sample size considerations
- Analysis plans
- Statistical reports
- NDA statistical sections
- Statistical programming
- Custom tables, listings and figures
- Extensive validation
- Legacy database integration
- Submission datasets based on current CDISC guidelines
- Comprehensive database and SAS program documentation
Our biostatisticians and programmers boast a rare combination of scientific expertise and operational skill, based on decades of participation on integrated drug development teams and data monitoring committees, hundreds of consulting assignments and direct interactions with local and international regulatory bodies, including the FDA, EMEA and local European regulatory agencies.
Moreover, UBC’s SAS programming staff remains continuously active in organizing and conducting educational and training activities for SAS users throughout the pharmaceutical and biotechnology industries.
UBC delivers the highest quality clinical data management services, following comprehensive standard operating procedures designed to ensure data quality, promote efficiency and drive timely project execution.
Our data management experts – who bring to our clients a combination of deep scientific knowledge and operational skill -- utilize various paper and web-based systems for tracking, data entry, data review and coding.
We offer:
- Database design and setup
- Data input in any format
- Case report form (CRF) design
- Double data entry, review and cleanup
- Coding of adverse events and medications
- Database lock
- Data validation, SAE reconciliation
- Page, record and query tracking
- Complete audit trail
- User and dataset security
- Customized status reporting, performance metrics