Data management is an effective tool for receiving and cleaning clinical data to obtain credible, accurate, and reliable data.

Our specialists are experienced in a variety of therapeutic areas and stages of clinical trials and trained in a multitude of data management tools. We offer a full range of data management services, including:

  • participation in design of Study Protocols, to ensure data is collected and managed appropriately
  • development of Data Management Plan
  • development of both electronic and paper-based case report forms (CRFs) in Electronic Data Capture (EDC) system using CDISC SDTM, CDASH standards
  • performance of data validation activities, including project-specific Edit Check Specification, Data Validation Plan, automated checks programming, entry masks creation, and manual data review
  • development of Data Transfer Plan
  • data entry and CRF tracking for paper CRFs
  • user training for EDC system and CRF completion rules
  • data loading from external sources (central lab, ECG, etc.)
  • integration of randomization module and dispensing drug (IWRS) directly into EDC system
  • quality control of entered data
  • data cleaning activities for interim and final database lock
  • Data Management Report preparation for quality control and metrics measurements
  • Medical coding using MeDRA, WHODD, and SAE reconciliation