Expert eyes on your data
Site training, motivation, and meticulous clinical monitoring in accordance with ICH-GCP standards are crucial to obtaining evaluable study data. SCOPE builds local monitoring teams with experienced clinical research associates (CRAs), who closely manage site performance to avoid protocol violations, maintain low query rates, and ensure study enrollment as well as on-site logistics.
SCOPE deploys teams of local office-based, permanent CRAs from national offices to provide a cost-effective solution. Consistent high-quality clinical monitoring is ensured through periodic co-monitoring of all trials, coupled with project-specific monitoring plans and periodic CRA training and mentorship delivered by CRA managers.
Our CRAs have considerable clinical research expertise, broad therapeutic experience, and strong communication and interpersonal skills that are vital for good site-sponsor relationships. At SCOPE, we believe that clinical operations are not only about making sure that the project runs smoothly through high-quality monitoring and management, but also about delivering personalized services.
Our site management process ensures fast, proactive support that you and the sites can rely on. Our CRAs provide general and study-specific site training (e.g. ICH-GCP, protocol, EDC systems), have continuous site overview, perform remote monitoring, and support the sites to optimize their recruitment strategy. They maintain close personal contact to identify and solve any potential problems as well as maintain site motivation.
- Expert, experienced CRAs (permanent, local and office-based)
- All monitoring activities in accordance with ICH-GCP standards
- Co-monitoring and training programs to ensure quality across all sites and countries
- Risk-based monitoring
- Remote monitoring
- Site overview and proactive site management
- Site training and support with the study documentation
- Patient recruitment strategies