DATA MANAGEMENT IN CLINICAL TRIALS
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