Data Management & Biostatistics
Our clinical data management team is made up of seasoned data managers and programmers with regular training who provide quality database setup, data integration, data cleaning, and database lock.
Specific data management services include, but are not limited to:
- Guidance in selection of the most appropriate data management tools
- Development of study documents, including case report forms, data management plans, and data transfer agreements.
- Design, implementation, and maintenance of an electronic data capture system for data collection, edit checks, specimen tracking, and study metrics reporting
- Development and execution of a web-based randomization system
- Provision of web-based training on electronic data capture and randomization
Implementation of a data quality assurance strategy, including ongoing data cleaning and site assistance with online data query resolution - Coordination of external (e.g., core laboratory) data transfers and reconciliation
Medical coding - Programming of interim and final analytic data sets
Our biostatisticians are accomplished with extensive experience in study design, data safety monitoring board (DSMB) support, generation of statistical reports, and manuscript preparation.
Specific statistical services include, but are not limited to:
- Study design, selection of outcome measures, and sample size estimation
Collaboration on writing of the study protocol and other study documents
Analysis of specialized, disease-specific outcome measures - Development and/or review of statistical analysis plans and DSMB charters
- Design and programming of tables, figures, and listings for clinical study reports
- Coordination of DSMB teleconferences and in-person meetings
- Statistical analyses and programming for interim and final reports
- Scientific support and statistical outputs for manuscripts and presentations to ensure timely dissemination of study results
