Data analysis

A typical study, even done in a single country, requires data linkage from several data sources, such as population-based registries, clinical databases, laboratory information systems, and study-specific data. As study coordinator, we handle all elements of the data analysis phase:

  • Develop a master study protocol appropriate for the study aims to fulfill all requirements (e.g., regulator-required templates and checklists for postauthorisation safety studies)
  • Design of an appropriate analytic strategy using state of the art methods as documented in a statistical analysis plan (SAP)
  • Advise on the optimal level of data sharing in multinational studies and implement the chosen model
  • Implement the most appropriate analysis when combining multinational data (patient-level analysis vs. aggregated data analysis vs. meta-analysis of estimates)
  • Provide expert advice on statistical methods throughout the study

DCE’s team of approximately 25 full-time biostatisticians at Master or PhD level has extensive experience in analyses of data linked from diverse data sources, both in Denmark and in other countries. Over the years, our team of statisticians has developed, validated, and fine-tuned an extensive library of programs and macros in SAS, STATA, and R which can be customized efficiently to a given project aim.