Under the responsibility of Project Managers (PMs) and the Clinical Operations Director, ClinSearch’s international team of experienced Clinical Research Associates (CRAs) has the ability to recruit, manage and monitor investigation sites across all of Europe, as well as some Middle Eastern and North American territories. Exhibiting a high level of autonomy and responsibility, our CRAs provide customers with the most accurate, complete clinical data, with proper documentation of the ongoing recruitment and follow-up process. They undergo specific training in early problem spotting and reporting, so that timely corrective actions can be taken. Here is a short summary of our clinical operations services:
- Feasibility assessment;
- Site selection;
- Regulatory submissions to CA and EC;
- Investigator recruitment and training;
- Investigators and steering committees meetings organization;
- Technical and screening support;
- Site management (initiation, routine monitoring, queries management, cleaning & close-out);
- CTC services.
ClinSearch’s monitoring processes are deeply rooted in best-in-class industry standards, international guidelines and regulations, and ethical principles of research (please see our Quality Policy and Compliance Statement). These are regularly improved with our growing experience or when new valuable ideas or methods arise. Our Standard Operating Procedures (SOPs) are available on request, although we will gladly accept to work with yours, should you require it.