Integrated Clinical Research Services
Globyz Clinical Solutions coordinates Phase I through Phase IV clinical research services in collaboration with CEBIS USA LLC, its U.S. affiliate and clinical research arm. Our combined clinical model brings together regulatory, operational, data, statistical, safety, quality, medical writing, and trial supply capabilities under defined governance and sponsor communication. Clinical studies are conducted through CEBIS USA in close collaboration and coordination with Globyz Clinical Solutions under the affiliate framework.
A Delivery Model Built Around Your Program
Sponsors may engage Globyz Clinical Solutions for an integrated workstream, a defined functional service, a country expansion, a study transition, or targeted rescue support. Globyz coordinates the proposed model with CEBIS USA according to the protocol, development phase, geography, sponsor resources, risk profile, and timeline.
Integrated Support
One governance framework across the clinical functions included in the agreed scope. Ensures seamless communication and delivery.
Functional Support
Experienced resources for a defined function or deliverable. Scalable solutions tailored precisely to your immediate requirements.
Rescue & Transition
Structured assessment, responsibility transfer, issue prioritization, and stabilization to get your trial back on track efficiently.
Canada Entry Support
Regulatory and operational planning for international sponsors entering Canada, ensuring compliance and smooth execution.
Clinical Service Groups
Eight integrated service groups — coordinated across Globyz Clinical Solutions and CEBIS USA under a single governance framework.
Regulatory Affairs
Expert support for clinical trial applications, authority interactions, submission planning, and lifecycle regulatory compliance strategy.
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Medical Writing
Preparation of trial protocols, investigator materials, informed consent forms, clinical study reports, and regulatory documents.
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Clinical Operations & Project Management
Comprehensive study planning, site feasibility, monitoring, vendor coordination, issue management, CTMS oversight, and trial closeout.
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Clinical Data Management
Expert eCRF design, database planning, rigorous data review, reconciliation, cleaning, and secure clinical database closeout.
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Biostatistics & Statistical Programming
Strategic design input, sample size planning, statistical analysis, comprehensive programming, and robust submission data support.
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Pharmacovigilance & Medical Monitoring
Dedicated safety planning, medical oversight, case processing workflows, reconciliation, precise reporting, and comprehensive aggregate support.
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Clinical Quality Assurance
Risk-based quality management, comprehensive audits, inspection readiness preparation, CAPA support, and continuous controlled quality oversight.
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Clinical Trial Supply Management
Strategic supply forecasting, sourcing, packaging oversight, RTSM integration, precise distribution, inventory accountability, and returns management.
Learn MoreCoordinated Clinical Delivery With CEBIS USA
GCP Compliant
Quality Systems
Multi-Country
Coordination
Globyz Clinical Solutions works in close collaboration and coordination with CEBIS USA LLC, its U.S. affiliate and clinical research arm, to provide integrated clinical research services across sponsor engagement, program planning, regulatory affairs, clinical operations, data management, safety, quality, administration and business support.
Clinical studies are conducted with CEBIS USA in close collaboration and coordination with Globyz Clinical Solutions under the affiliate framework. Before work begins, the proposal and contract clearly identify the respective responsibilities, delivery teams, systems, vendors, reporting arrangements, governance and escalation pathways.
Explore Clinical Services with CEBIS USAFrom Enquiry to Delivery
Requirements Review
Confirm protocol status, countries, sites, populations, timelines, services, and sponsor responsibilities.
Feasibility & Proposal
Globyz and CEBIS USA coordinate assumptions, responsibilities, deliverables, governance, technology, quality requirements, and commercial terms.
Start Up & Transition
Approve plans, establish systems, train teams, activate vendors, and confirm reporting.
Study Delivery
Track milestones, data, quality, safety, supplies, issues, decisions, and risks through agreed governance.
Closeout
Complete reconciliations, documentation, data and report deliverables, archiving, and lessons learned.
Requirements Review
Confirm protocol status, countries, sites, populations, timelines, services, and sponsor responsibilities.
Feasibility & Proposal
Globyz and CEBIS USA coordinate assumptions, responsibilities, deliverables, governance, technology, quality requirements, and commercial terms.
Start Up & Transition
Approve plans, establish systems, train teams, activate vendors, and confirm reporting.
Study Delivery
Track milestones, data, quality, safety, supplies, issues, decisions, and risks through agreed governance.
Closeout
Complete reconciliations, documentation, data and report deliverables, archiving, and lessons learned.
Start a Clinical
Discussion.
Share the study synopsis or protocol, target countries, planned timelines, required services, and preferred engagement model. Globyz Clinical Solutions will coordinate the discussion with the appropriate clinical team.