Data management and biostatistics

Clinical Data Management

We provide the following data management services:

  • support of protocol development,
  • randomization,
  • eCRF creation and review,
  • database creation and data entry,
  • query management,
  • customized status reporting,
  • database cleaning and validation,
  • data extraction,
  • and clinical study report.

All services follow Standard Operating Procedures, CDISC and Good Data Management Practice standards.

Biostatistics

Following the motto that everything is data we apply both simple and state-of-the-art statistical methods to all of possible stages of clinical trial including:

  • randomization scheme,
  • sample size calculation,
  • statistical analysis plan,
  • interim analysis,
  • statistical report,
  • clinical study report,
  • statistical consulting.

Our data management and biostatistical services support clinical scientists and medical writers to ensure accurate and scientifically correct compilation, presentation and interpretation of the results for the study reports, presentations and publications.