Clinical Site Monitoring
Clinart MENA provides comprehensive site monitoring and management, including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites in the Middle East, North Africa, Europe and the rest of world. Our Clinical Research Associates (CRAs) act as the liaison between the sites and the study team. Our CRAs are assigned to specific sites for the duration of the study to provide consistent support for sites. All monitoring activities are conducted in accordance with GCP/ICH Guidelines and follows FDA/EMEA regulations. Clinart develops Sponsor-approved monitoring plan for each study. Monitoring visits are conducted at pre-determined intervals and/or as the study needs dictate.
Our CRAs are both office and regionally based to ensure adequate distribution of CRAs across the globe and to allow for cost-effective travel time to sites within their region. This local presence becomes increasingly important for multi-national trial management where familiarity of the local language and local knowledge of regulatory issues can be critical. Our CRAs are experienced in numerous therapeutic areas across drug, biologic and device trials. Assignment to a specific program is made in consideration of indication experience, site location and Sponsor requirements. All CRAs have state-of-the-art communications tools in place to provide timely and responsive communications, real-time data accessibility and centralized tracking and management of procedures.
Clinical Site Monitoring Services include:
- Site Identification
- Site Qualification and Initiation
- Subject Accrual/Retention Strategy Enhancement
- Regulatory Document Preparation and Collection
- Budget and Contract Negotiation
- Investigator Meeting Planning and Presentation
- Site Personnel Training
- Interim Site Monitoring
- Clinical Study Material Accountability
- Site Termination