Tech Observer provides comprehensive site monitoring and management, including the assurance of protocol compliance, accurate data capture, and GCP/ICH compliance at investigative sites. 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 ICH GCP compliance and data integrity during each site visit, consistently retrieving high quality, on-time data. Tech Observer’s Clinical monitoring team ensures the adherence with standard operating procedures (SOPs) and strives to promote positive personal relationships with a high level of trust and confidence with all our customers.
Tech Observer CRAs are both office and regionally based and are experienced in numerous therapeutic areas across drug, biologic and device trials. All of our 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.
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
