Clinical Site Monitoring
ESTERN Medical provides comprehensive site monitoring and management, including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites in two continents (US North and Latin America) across Mexico, Colombia, Chile, Brazil, Peru and Argentina.
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 and LATAM regulations. ESTERN Medical 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 international offices based and regionally geographic based to ensure adequate distribution of CRAs across the specific geographic location 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 languages, knowledge and regulatory issues that are critical to any trial. Our CRAs are experienced in numerous therapeutic areas across pharmaceutical, biologics and medical device trials.
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:
- Clinical Site Identification.
- Pre and Site Qualification and Initiation.
- Subject Accrual/Retention Strategy Enhancement.
- Regulatory Document Preparation and Collection.
- Budget and Contract Negotiation.
- Investigator Meeting Planning and Presentation.
- Clinical Site Personnel Training.
- Interim Site Monitoring.
- Clinical Study Material Accountability.
- Site Termination/Close Out.