Our data management team provides high-quality collection, organization, validation, and quality control of clinical trial data and utilizes electronic source records (ESR), electronic data capture (EDC) or paper, to expedite data collection. Agility utilizes a number of different EDC platforms to meet your specific study and site requirements.
Working closely with Sponsor project teams, our data managers develop detailed specifications for the collection, organization, validation, analysis, and quality control of clinical trial data ensuring the most cost-effective, secure, and regulatory compliant process. Our responsive approach allows flexibility in accommodating changes to project specifications with minimal (if any) timeline adjustment, all while maintaining the highest levels of data quality and integrity.
Data Management services:
- Design of case report forms (CRFs), in either electronic or paper form
- Definition of edit checks and project-specific data management processes
- Validation of project-specific components of the data management system during the initial setup and throughout the trial as modifications are introduced
- Review of clinical data for errors or trends and generate electronic queries
- Integration of data from external sources to ensure consistency with CRF data
- Medical coding using standardized dictionaries such as MedDRA, WHO Drug, or Sponsor-specific dictionaries
- Delivery of a clean, analyzable database in customized formats, adhering to Clinical Data Interchange Standards Consortium (CDISC) standards.
- Assist with reconciliation of serious adverse events.