Data Management


Collection of reliable, accurate and conclusive clinical data is one of the primary objectives of clinical studies.
Our experienced data managers help to achieve this objective. Depending on your needs we recommend data collection on paper or via eCRF. We design the (e)CRF, manage the data collection and data cleaning process and provide a clean database at the end.
Our processes allow the conduct of interim analyses shortly after the last relevant data are documented.

Our services in this area include:

  • CRF design (paper CRF, eCRF, questionnaires, diaries)
  • Data management plan
  • Data validation plan
  • Database design
  • Double data entry
  • Data cleaning
  • Electronic Data capture, see eServices
  • Data cleaning
  • Medical data review
  • Medical coding (e.g., MedDRA)
  • Generation of pooled databases

Biostatistics


Our experienced statisticians support your studies from the initial planning stage until the final report and publication. Our services in this area include:

  • Biostatistical planning and consulting
  • Statistical contribution to the study design, endpoints, sample size, study protocol
  • Randomisation
  • Statistical analysis plan
  • Interim analysis
  • Organisation of DMC (Data Monitoring Committee)
  • Organsation of DSMB (Data Safety Monitoring Board)
  • Statistical evaluation with SAS®
  • Statistical interpretation of results
  • Statistical support for publications