Data Management in clinical trials

Data Management

 

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