Site Management & Monitoring
Clinical Study Site Management & Monitoring is a critical service that ensures study sites are engaged, trained, compliant and performing at their best throughout the study lifecycle.
This service bridges the gap between Sponsor goals and day-to-day site protocol execution.
Engaged, trained, and supported sites mean faster, cleaner, and more compliant studies. From green-light to close-out, we stay close to your sites so that you can stay focused on results.
Let’s Make Your Sites High-Performing Partners.
Clinical study site management and monitoring typically encompasses the following components:
Site Start-up Oversight
- Coordinate and support site selection and qualification
- Support, manage and oversee Investigator meetings
- Plan and execute Site Initiation Visits
- Collect essential regulatory documents and perform a quality review
- Support site contract and budget negotiation
- Track regulatory green-light at country and site level
- Track site activation against activation plan and targets
Ongoing Site Management
- Deliver routine site communication and engagement
- Plan site visits and review documentation (interim monitoring visits; remote visits)
- Track site performance (enrolment; protocol adherence; data entry timelines)
- Identify and resolve site-level issues or risks
- Follow-up on queries, deviations and site feedback
Site Training & Support
- Train on protocol, Participant Information Sheet/Informed Consent Form, safety reporting, and study systems (e.g., Electronic Data Capture, Interactive Web-based Randomisation System)
- Conduct re-training after protocol amendments or staff turnover
- Create Frequently Asked Questions documents and site support toolkits
- Provide on-call support for operational or compliance questions
Close-Out Activities
- Plan site Close-out Visits and review documentation
- Oversee final essential document collection
- Support Investigational Product reconciliation and destruction
- Assist with archiving and audit preparation