Clinical Operations Built for
CEBIS supports clinical study execution from planning and start-up through site management, monitoring, patient recruitment, clinical supply coordination, quality oversight and study closeout.
Clinical operations can be provided as focused support for a specific need or coordinated with data, regulatory, safety and other functions as part of a broader clinical development program.
The Functions That Keep a
Successful study execution depends on coordination between the sponsor, project team, participating sites, patients and supporting functions.
CEBIS brings these activities together through five core clinical operations services.
Clinical Trial & Project Management
Study planning, milestone management, cross-functional coordination, issue management and sponsor communication throughout study delivery.
Site Management & Monitoring
Site identification, start-up, ongoing site coordination, clinical monitoring and closeout support.
Patient Recruitment, Retention & Adherence
Recruitment and participant-engagement activities designed around the protocol, eligibility criteria and target study population.
Clinical Supply & Logistics
Coordination of clinical materials, sourcing, packaging, storage, distribution and site supply requirements.
Quality Oversight, Inspection Support & Study Rescue
Quality-focused oversight, issue management, inspection preparation and support for studies requiring additional operational attention.
Operational Support
Study Planning
Translate protocol requirements into an operational plan, including responsibilities, timelines, site needs and supporting functions.
Study Start-Up
Manage the activities required to prepare participating sites and study teams for activation.
Site Activation
Support site initiation, documentation readiness and preparation for active study conduct.
Enrollment & Execution
Oversee ongoing site activity, recruitment, monitoring, supply needs and operational issue management.
Data & Study Oversight
Keep clinical activities aligned with data review, safety, regulatory and quality requirements during study conduct.
Closeout
Coordinate final site activities, outstanding actions and study documentation as the program moves toward completion.
Preparing Sites for Study Delivery
Feasibility
Review protocol and study requirements to help identify appropriate site characteristics and operational needs.
Site Identification
Evaluate potential participating sites based on the study population, protocol requirements and project plan.
Site Start-Up Coordination
Support the activities needed to prepare sites for study initiation.
Site Communication
Maintain clear communication around documentation, timelines, study requirements and outstanding actions.
Oversight Throughout Active Study Conduct
Monitoring support can include:
- Site initiation visits
- Site monitoring visits
- Risk-based monitoring
- Co-monitoring
- For-cause visits
- Audit-related visits
- Inspection-readiness support
- Closeout visits
- Follow-up of site actions and study issues
Recruitment and Engagement
Recruitment
Identify and reach potential participants through appropriate study and site channels.
Retention
Maintain communication throughout the study to support continued participation.
Adherence
Use reminders, education and practical communication to help participants follow study requirements.
Clinical Operations Connected to the Wider Program
Connected functions can include:
- Data Management
- Biostatistics
- Regulatory Affairs
- Pharmacovigilance
- Medical Monitoring
- Medical Writing
- Clinical Supply
- Quality Oversight
Need Clinical Operations Support for Your Study?
Tell us about your study phase, countries, sites, patient population, timeline and operational needs. A member of the CEBIS team can discuss the appropriate level of clinical operations support.