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