Methodology, Biostatistics and Data Management Program

About MBDMP

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.

Services

  • 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.

Functional Organization

SCReN centres

29 support units to conduct research (UICECs) integrated into the NHS care centres distributed in 11 autonomous communities.

Click on an Autonomous Region for more information:

  • Cataluña

    HOSPITAL CLINICO Y PROVINCIAL DE BARCELONA
    www.idibaps.org
    MRP MBDMP

  • Galicia

    INSTITUTO DE INVESTIGACION BIOMEDICA DE A CORUÑA (INIBIC)
    www.inibic.es
    MRP MBDMP