Data Management in clinical trials

Data Management

 

Data management helps to achieve timely and accurate data accommodation.

Our specialists have extensive experience in data management in different therapeutic areas and stages of clinical trials.
We offer a full range of data management services, which includes:

  • study protocol approval by the data management team
  • development of both electronic and paper-based case report forms (CRFs)
  • creation of an electronic data collection system (Electronic Data Capture), including programming of automatic and manual reconciliations and masks
  • data Management Plan preparation
  • data validation scheduling (Data Validation Plan)
  • information entering into an electronic database from paper CRFs by two independent inputs
  • providing trainings on filling and maintaining eCRFs to the users
  • EDC users support .
  • loading data from external sources
  • integration of randomization module and dispensing the drug (IWRS) directly into the EDC system
  • constant monitoring of the entered data quality
  • preparation of a database to the interim and final lock (Database Lock)
  • writing data processing report
  • upload data in different formats, depending on customer requirements
  • medical coding using MedDRA, WHO DD etc.
  • use of CDISC SDTM, CDASH standards