Management and processing of clinical trial data

Data management in clinical trials is the collection, aggregation, validation and quality control of all clinical trial data. The ultimate goal of CT data management is to ensure that the conclusions drawn from the study are supported by the data collected.

We offer a full range of CI data management services:

• participation in the development of the study protocol of specialists in data management of clinical trials
• development of a paper individual registration card (IRC)
• development of an electronic individual registration card (eIRC) based on the Electronic Data Capture system, including programming of automatic data validation tools (checks, masks, triggers)
• development of a Data Management Plan
• development of a Data Validation Plan
• entering information into the electronic database from paper CRFs using the “double entry” method
• conducting trainings on filling out and maintaining the CRF/eRCF
• EDC user support
• loading data from external sources
• continuous quality control of the entered data
• preparing the database for intermediate and final closure (Database Lock)
• uploading data in various formats, depending on customer requirements