Clinical Operations Services
End-to-end trial execution support from site activation to database lock, integrating best-in-class CTMS tools and operational expertise.
Integrated Operations Solutions
Globyz Clinical Solutions manages study planning, feasibility, start-up, monitoring, vendor oversight, risk management, issue escalation and closeout across the agreed program. These clinical operations are delivered through the integrated affiliate framework of Globyz Clinical Solutions and CEBIS USA LLC, its U.S. affiliate and clinical research arm, using a coordinated model for study planning and conduct.
Global Reach
Multi-regional Trial Networks
ICH GCP Compliant
Quality & Regulatory Standards
Operational Excellence
Efficient, compliant trial management at every phase
Study Planning and Start-Up
We coordinate every element of study set-up — from the earliest feasibility conversation through to site activation — ensuring a structured, documented, and timely transition into conduct.
Activation Oversight
From feasibility to first patient
Operational feasibility and study planning
Country, site, and investigator feasibility support
Site selection and qualification coordination
Start-up planning, essential document tracking, and activation oversight
Vendor, laboratory, safety, data, and supply interface planning
Project Management and Governance
An agreed governance plan defines responsibilities, meetings, decisions, reports, escalations, and communication pathways.
Timelines & Milestones
Integrated timelines, milestones, dependencies, and action tracking
Budget & Scope
Budget and scope monitoring according to the contract
Risk & Issue Mgmt
Risk, issue, deviation, and decision management
Sponsor Reporting
Sponsor status reporting and cross-functional coordination
Change & Closeout
Change assessment and closeout planning
Sponsor-agreed governance at every level of the study program.
Monitoring and Risk Based
Quality Management
Monitoring strategy is tailored to protocol risk, site needs, data signals, and sponsor requirements.
Monitoring Plan Development
Monitoring plan development and visit scheduling
Monitoring Activities
On-site, remote, and centralized monitoring activities as agreed
Performance & Compliance Review
Site performance, data quality, safety, and protocol compliance review
Issue Escalation & Resolution
Issue escalation, follow-up, and documented resolution
Closeout & Document Reconciliation
Closeout and essential document reconciliation
CTMS and
Study Oversight
The clinical trial management system supports milestone, site, visit, issue, document, and reporting oversight within the configured scope. System access, validation responsibility, data ownership, interfaces, training, and support are defined before use.
System Configuration
CTMS configured to the agreed scope before study go-live
Access & Validation
System access, validation responsibility, and data ownership defined upfront
Interfaces & Training
System interfaces, training plans, and ongoing support confirmed before use
Real-Time Reporting
Enrollment, visit, issue, and document status visible through configured dashboards
Transition or Rescue Support
For an ongoing study, we assess current status, critical risks, contracts, data, safety, supplies, vendors, systems, and documentation before agreeing a transition plan. Priority actions and responsibilities are confirmed with the sponsor before operational transfer.