Study Monitoring and Site Management

What We Do

Study monitoring at Niche is carried out by experienced clinical research associates who understand both the science behind the studies they work on and the regulatory standards they are expected to uphold. We provide monitoring services for Phase I through Phase IV trials, across a range of therapeutic areas. 

Site management goes hand in hand with monitoring. We work with investigator sites to ensure they have what they need to participate effectively, from initial set-up and training through to close-out and archiving. The relationship we build with sites has a direct impact on data quality and recruitment performance.

How We Work

We develop a monitoring plan for each study that reflects the risk profile of the trial, the experience of the sites involved, and the expectations of the sponsor. Monitoring visits are conducted according to that plan, with clear written reports provided after each visit and outstanding issues tracked to resolution. 

Remote monitoring has become an important complement to on-site visits in recent years. We use centralised monitoring approaches where appropriate, reviewing data in real time and flagging concerns without always needing to be physically present. This reduces burden on sites while maintaining the level of oversight the study requires.

Scope Of Service

• Site selection visits and feasibility assessments 
• Site initiation visits and investigator training 
• Routine on-site monitoring visits 
• Remote and centralised monitoring 
• Patient recruitment support 
• Protocol deviation identification and management
• Data query resolution 
• Informed consent review 
• Investigational product accountability checks 
• Regulatory document review at site 
• Safety reporting oversight 
• Site close-out visits 
• Archiving support for investigator site files