HOSPITAL CLINICO Y PROVINCIAL DE BARCELONA
Methodology, Biostatistics and Data Management Program
The Methodology, Biostatistics and Data Management Program is based on the extensive experience obtained in experimental and observational clinical research by the central and peripheral nodes that make up this program.
With a clear vocation for integrating resources to increase the system's efficiency to its maximum, this program provides project analysis tasks, it creates and manages the electronic Case Report Forms (eCRFs), which are validated and hold the highest standards in quality, compatible with the execution of multinational clinical trials.
- Statistics and methodology assessment and advisory services, complying with both the scientific and regulatory requirements.
- Study design: statistical protocol, sample size. Complex designs.
- Strategies and techniques of centralized randomization and variants.
- Development of databases with electronic access (eCRF).
- Data Management Planning and Standards.
- Data Management on electronic Systems.
- Design of the data Analysis Plan.
- Data analysis and statistical reports, statistical programming with a SAS program. Consult alternatives with R, Stata.
- Coordination and interaction with other SCReN programs.
- Data and statistics management processes in accordance with SOPs, in compliance with GCP guidelines and regulatory agencies (EMA, FDA).
Any of these activities may be consulted before starting the preparation of a protocol or the submission of an application to a Call, an Agency or an Institution.