BBMCT is responsive, flexible, and knowledgeable in our approach so you can have complete confidence in your data for the entire duration of drug development. We undertake each study with your goal in mind, preparing your data for submission.
Working closely with Sponsor project teams, the BBMCT data management team develops detailed specifications for the collection, organization, validation, and analysis, of clinical trial data that ensures the most cost-effective, secure, and regulatory compliant process. Our extensive knowledge and experience, combined with superior therapeutic and regulatory expertise, provides confidence to the Sponsor. The data collection, validation and analysis process will follow the most robust process that focuses on precision and efficiency while maintaining the highest levels of data quality and integrity.
- Designs case report forms (CRFs) following the CDASH standard
- Performs double-data entry of CRFs (paper only)
- Validates all project-specific components of the data management system
- Reviews clinical data for errors and trends and generates electronic queries
- Integrates data from external sources to ensure consistency with CRF data
- Provides medical coding using standardized dictionaries
- Delivers a clean, analyzable database, adhering to Clinical Data Interchange Standards Consortium (CDISC) standards
- Reconciles serious adverse events
- Produces real-time clinical trial metrics
- Operates seamlessly in multiple EDC platforms.
Our experienced team of biostatisticians provides trial design consultation, statistical methodology recommendations, programming expertise, and reporting accuracy necessary to deliver your trial efficiently and on time. Data analysis is performed using industry-standard SAS® software. Services include:
- Comprehensive data analysis plans, including sample size determinations, detailed descriptions of statistical methodologies, program specifications, and mock examples of all deliverables
- Preparation and generation of randomization plans
- Preparation of customized analysis programs thoroughly tested and validated according to documented procedures
- Interpretation of study results and writing support for study reports and manuscripts
- Integrated efficacy and safety analysis for regulatory submissions
- Adaptive design consultation to help lower development costs and reduce time to market