Data management

We develop services in the clinical trial data management.

They include:

  • development of the central trial database,

  • events tracking,

  • double data entry,

  • central patient allocation,

  • reporting of adverse events according to the regulatory standards

  • monitoring of trial safety and data safety or external event adjudication services

  • statistical reports and analysis performed by experienced university affiliated statisticians

KCRI is experienced in employing the modern techniques of remote data entry and networking. We also review the proper statistical methods to be used in the trial, randomization schedules and statistical analysis according to the best test applicable.

All these activities are constantly reported and Sponsor receives "ready-to-use" reports on statistics, data quality and consistency, medical relevance, clinical issues, scientific reviews and publication materials.

KCRI has its own CORE LABORATORY for angiography image analysis equipped and standardized according to the European and US standards - for details look at the full desription.