RAeClinica is working with pharmaceutical, biotechnology, and clinical research organisations in the United States, Europe, Latin America and in Asia covering Clinical Research, Clinical Data Management, Biometrics and Clinical Project Managers.
We also provide staffing resources on a contract full-time or temporary basis.
Our professional staffs have broad experience providing in-house paper and electronic capture data services, ensuring that your deadlines are strictly met, and achieving the highest levels of data quality.
- CRF or electronic Case Report Form (eCRF) design and review
- Data management plans
- Database design and testing
- CRF tracking and processing
- Double-data entry and Quality Control (QC) sampling for paper-based studies
- Ongoing data review via edit checks and listings
- Medical coding and review using MedDRA and WHODrug dictionaries
- Query generation and processing
- Electronic data integration and transfer
- Serious adverse event reconciliation
- Customized status reports
- Thorough multi-discipline QC review prior to database lock
Biometrics consultants are available for reliable, expert consultation to help you preparing Statistical Analysis Plans, Regulatory Submissions or Protocol review.