Services
We take pride in providing turn-key clinical trial solutions to our Sponsors and Investigators both. Our system enables our experienced physicians to participate in clinical trials in their therapeutic areas, and have a complete involvement with every patient in the study. We believe in patient safety along with data quality. In-house 21 CFR Part 11 Compliant EDC (Electronic Data Capture) Data Management system allows us to keep outstanding data quality throughout the project.
As a SMO Partner, SITE OBSERVER provides you qualified on-site Clinical Research Coordinators, Regulatory Specialists, Data Management Expertise, and the most experienced and efficient Site Clinical Operations group for:
- Document preparation
- Study patient scheduling and visit preparation
- Continuous Validation of Patient Profiles
- Dedicated staff to help patient retention
- Data collection by data management experts
- Internal QA (Quality- Assurance) and QC (Quality Control)
- Data entry
- 24/7 access through a 21 CFR Part 11 Compliant channel
- Study monitoring visit activities
- Audits