Clinical Data Management
Everest’s foundation is built on excellence in clinical data management, from trial case report form (CRF) design through to database lock.
“Execution excellence” has been used by many clinical trial sponsors when describing their experience with Everest’s clinical data management services.
Everest offers both electronic data capture (EDC) and paper/fax-based solutions that are customizable and cost-effective for clinical trial data management. The following data management services are provided at Everest.
- Data capture and management using EDC systems.
- CRF/eCRF design and annotation.
- Data management plan writing and maintenance.
- Database design and maintenance.
- Data processing and quality control, including third party data integration and cleaning (e.g. central lab data, eDiaries, etc.)
- Safety data review and reconciliation of adverse events and serious adverse events.
- Medical terminology coding using MedDRA and medication coding using WHODrug.
- Database QA acceptance sampling prior to database lock, and additional database checks by Everest statistical team.
- Secure web portal for real-time access to study progress reports, query reports, subject data listings and summary tables, etc.
- Ongoing support for users of data management systems and tools, including user training and helpdesk operation.
- Database lock.
- Database archival.
Everest’s clinical data management services are provided following ICH, GCP, and regulatory agency guidelines, using controlled and secure computing environments with validated software and systems (21 CFR Part 11 compliant) and well-designed workflow processes and procedures. Everest gains efficiency and assures quality through the use of standard operating procedures, including the use of templates for standard CRF/eCRFs, data management plans, user acceptance test plans, data review checklists, database quality acceptance sampling plans, database lock checklist sign-off sheets, etc.