SITE MANAGEMENT & MONITORING
Site Oversight from Feasibility
Through Closeout
CEBIS supports clinical research sites throughout the study lifecycle with feasibility, site identification, study start-up, ongoing site management, clinical monitoring and closeout activities.
Monitoring can be adapted around the protocol, study risks and operational requirements.
SITE STRATEGY
Finding Sites That
Fit the Study
Site feasibility and identification should begin with the protocol, study population and operational requirements so candidate sites can be assessed against the needs of the study.
Protocol Review
Understand the study population, site requirements and operational expectations.
Feasibility Assessment
Evaluate whether potential sites are positioned to support the protocol.
Site Identification
Identify sites that fit the study requirements and target participant population.
Site Selection Support
Coordinate information needed to support sponsor study-site decisions.
STUDY START-UP
Preparing Sites for
Active Study Conduct
Once sites are selected, the focus moves to preparing them for study execution.
CEBIS can coordinate site activities around documentation, communication, study requirements and initiation.
CEBIS can coordinate site activities around documentation, communication, study requirements and initiation.
01
Site Preparation
Coordinate outstanding operational activities before initiation.
02
Study Documentation
Support collection and review of required study documentation.
03
Site Initiation
Prepare site teams for the protocol, study processes and operational expectations.
04
Action Follow-Up
Track open items that need to be completed as the site begins active participation.
MONITORING SERVICES
Monitoring Based on Study Needs and Risk
Monitoring can be tailored to the study and may include initiation, routine monitoring, for-cause, closeout, co-monitoring, risk-based and inspection-readiness activities.
Site Initiation Visits
Support the site as it prepares to begin study activity.
Site Monitoring Visits
Review ongoing study conduct and follow required monitoring activities during execution.
Risk-Based Monitoring
Focus oversight on critical study areas and identified risks.
Co-Monitoring
Provide additional or collaborative monitoring support where required.
For-Cause Visits
Perform focused oversight when specific concerns or study issues require additional attention.
Audit & Inspection-Readiness Visits
Support review and preparation where additional quality or inspection attention is required.
Closeout Visits
Coordinate final monitoring activities as the site completes participation in the study.
SITE COORDINATION
Keeping Sites Connected Throughout the Study
Monitoring visits are only one part of effective site oversight.
Ongoing site management helps keep study teams informed, outstanding actions visible and operational issues moving toward resolution.
Support can include:
- Regular site communication
- Study updates
- Tracking outstanding actions
- Documentation follow-up
- Enrollment coordination
- Support with operational questions
- Issue escalation
- Coordination with project-management teams
- Closeout preparation
DATA QUALITY
Connecting Site Activity
to Study Data
Site management and monitoring should remain connected to the study’s data-management process.
Site management includes follow-up on EDC completion, data queries and open site actions, coordinated with broader data-cleaning, validation and database-lock activities.
Key focus areas:
- Timely data entry
- Query follow-up
- Outstanding study actions
- Documentation completeness
- Coordination with Data Management
- Readiness for database lock
STUDY COMPLETION
Supporting Sites Through Final Study Activities
Where required, monitoring can also connect with quality and inspection-readiness support.
CEBIS can coordinate final monitoring activities, documentation review, outstanding actions and preparation for study completion.
Site oversight continues through study closeout.
Need Site Management or Clinical Monitoring Support?
Tell us about your protocol, countries, sites, monitoring needs and expected timeline. A member of the CEBIS team can discuss the appropriate site-management and monitoring approach.