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Our Highlights
20+
Years of Experience
15+
Therapeutic Centers
of Expertise
500+
Hospitals & Clinics
20+
Countries across CEE
2000+
Investigative Personnel
350M+
Population
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Clinical Research Services
Clinical Research Services
Clinical Trial Support
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Clinical Development Program Management
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Flexible Clinical Monitoring Solutions
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Resources Optimization
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Efficient Study Start-up Initiation
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Patient and Site Engagement
Regulatory Affairs
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Regulatory Intelligence & Operational Expertise
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Strategic and Operational Regulatory Support
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Global Regulatory Consulting and Advisory
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Product Lifecycle Management
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Regulatory Documentation and Submissions
Drug Safety &
Data Management
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Established Safety Reporting System
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Standardization of Clinical Data
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Construction of Databases
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Pharmacovigilance Solutions
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Uniform Data Structuring
Medical Writing
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CERs and CEPs (Clinical Evaluation Reports and Plans)
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Clinical Research Literature Reviews
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User Documentation and Labeling
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Summaries of Safety and Clinical Performance (SSCPs)
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Implant Cards
Project & Trial Management
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Customized Employee Training and Development
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Advanced Technologies and Immediate Data Analysis
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Perpetual Enhancement of Operational Processes
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Adaptive Governance Structures
Biostatistics
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Statistical Analysis Plan Development
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Analysis and Reporting Including ISS/ISE
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Safety Event Identifications and Endpoint Adjudications Support
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Interim-Analysis and Safety Updates
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PK/PD Analysis
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