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Clinical Development
Site Management & Monitoring
Managing and monitoring clinical trial sites are an important process to ensure the quality and integrity of data collected during clinical trials, and furthermore, to ensure the safety and efficacy of products under study.
It checks compliance with GCP, related regulations, SOPs, and the protocol on clinical trial operation, and supervises activities such as site training and IMP management.
Spero's monitoring service provides comprehensive service to ensure the safety of research participants, the quality of collected data, and the integrity of clinical trial results.
DCT Site management
DCT Site management may include the use of digital technologies and virtual tools, such as online training modules (Learning Management System) and electronic document management systems (eTMF), and site monitoring in DCT ensures that site staffs are trained in the use of these digital tools and can perform study procedures in a virtual remote environment.
The DCT on-site monitoring and management involves careful planning and procedures to verify clinical trials are conducted in accordance with protocols and regulatory requirements, while taking advantage of digital technologies and remote data collection methods.
DCT Site monitoring
The goal of site monitoring in DCT is to ensure that the DCT environment adheres to protocols, collects data accurately and consistently, and reports adverse events in a timely and accurate manner. Spero's DCT Site monitoring includes the use of remote monitoring tools and other technologies such as video conference, remote data review, and centralized monitoring systems.
Process
Issue tracking
and escalation
Risk Management
Progress and Quality
Management
Site Management
Essential document management
Site communication, etc.
Service Scope
Service Scope
Issue tracking
and escalation
Site Management
Essential document management
Site communication, etc.
Progress and Quality
Management
Risk Management
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