The Biostatistics and Data Management Core Facility provides expert advice on data analysis and data management for the design, conduction and analysis of clinical investigation projects, based on 20 years of experience. We have statistical regulatory experience as expert consultants to regulatory bodies as the Spanish Medicine and Health Products Agency (Agencia Española del Medicamento y Productos Sanitarios -AEMPS-) as well as to other public institutions. We are active net participants in the European ECRIN project (www.ecrin.org), an independent platform to promote independent Clinical Investigation around Europe. The director and the coordinator of our team are university professors and they have a long and productive experience in education and training.

Services

• Design and analysis of clinical trials and other studies such as observational studies and meta-analysis:
  • Description and justification of statistical methods in protocols, sample size, randomization, interim analyses, multiplicity issues, handling of missing data, superiority and non-inferiority designs, statistical analysis plans, design and analysis of bioavailability and bioequivalence trials, multivariate analyses, statistical reports, among others.
• Data management:
• eCRF (electronic Case Report Form) specifically designed for clinical trials, validation plan, validated data base, data management plan, data entry, data control log, system log, queries, discrepancies, monitoring, partial or complete blocking of data, coding of medical terms (MedDRA) and medication (WHO), labs control, library, batch data entry, data monitoring, data clarification, data export, tailored reports, etc.
• Scientific manuscripts, elaboration of competitive projects
• Review of scientific journals, reports on regulatory and clinical investigation issues
• Courses for statisticians and non-statisticians
• Statistical support for:
• Education and training tasks on statistics, clinical trials and clinical investigation

All services related to clinical trials are conducted using Standard Operating Procedures (SOP) according to Good Clinical Practice (GCP).

Software

Data Management: The eCRF is run in a secure environment thanks to the use of a powerful electronic data capture software called MACRO™ by InferMed, hosted in secure data centres within Hospital Clinic that guarantee the integrity of the data at every moment according to safety regulations and GCP.

Statistics: SAS (reference tool for regulatory submissions), SPSS, R, nQuery (sample size), WinNonLin (PK/PD analysis)