> >
Study data management

Study data management

Vita Aeterna company provides the whole range of services on collection, transfer of information obtained in clinical studies to the electronic base for the further analysis.


Study arrangement:

  • CRF development and design;

  • Development of data management plan;

  • Database design and testing;

  • Preparation to control edition and testing;

  • Development of statistical analysis plan;

  • Creation of randomization codes. 

Study conduct: 

  • DB management/data introduction;

  • Data encoding (AE/SAE, diagnoses, drugs, etc.);

  • Management of data discrepancies;

  • Data encoding (using MERDA and WHODD dictionaries);

  • Data review (current quality control). 

Study completion:

  • Harmonization of SAE data;

  • Data control;

  • Closure of database;

  • Archiving of database;

  • Database transfer;

  • Data analysis;

  • Preparation of a statistic report.