Biostatistics

Adapting to the need of each project

CRO Biostatistics Team

Ana Patacão, Global Director and Catarina Silva, Country Manager

Biostatistics plays a key role in biomedical research, allowing an appropriate analysis and interpretation of the data collected during the study lifecycle in order to address its goals.

Our team of biostatisticians and statistical programmers provide services on the analysis and interpretation of results from clinical studies, as well as in study planning, assisting in study design, sample size calculation and definition of objectives or endpoints. These services aim to ensure you the quality of protocols and reliable data processing, all of which are crucial to the success of your research project.

We have an extensive experience in all phases of clinical development, in several therapeutic areas, adapting the services and timelines to the needs of each project, client and audience, always ensuring its high quality standards.

This unit also provides individual assistance and advising to research projects, giving the investigator the option to follow and understand all analyses carried out.

We work with the most appropriate statistical tools – SPSS and SAS – to maximize the data quality handling. Whether you need an integrated or single-solution we maximize the data efficiency and deliver a unique solution for your study.

Eurotrials’ Biostatistics department has over 12 years of national and international experience in statistical planning and analysis, adapting its services to the scientific needs of the project and to the applicable regulatory requirements.

By Therapeutic Area:

CRO Biostatistics Therapeutic Areas

Biostatistics Services

  • Methodological concept and statistical assistance in study design and protocol development
  • Sample size calculation
  • Definition of the randomization methodology; preparation of randomization lists and envelopes
  • Development of the statistical analysis plan (SAP)
  • Ongoing Data Analytics from EDC outputs
  • Statistical analyses (in SAS® or IBM SPSS – PSE), including interim exploratory and post-hoc analyses
  • Statistical support to Drug Monitoring Committees (DMC)s or Drug Safety Monitoring Committees (DSMB)s
  • Meta-analyses
  • Statistical reports
  • Assistance in the elaboration of the clinical study report, including the generation of data listings
  • Statistical consultancy
  • Assistance in master’s and doctoral theses
  • Presentation of results (preparation of scientific articles, posters and PowerPoint presentations)
SAS
SPSS