Clinical research services
End-to-end CRO support delivered to ICH-GCP standards, from study start-up through close-out, with risk-based oversight.
- Feasibility
- Site selection
- Clinical monitoring
- Project management
- Study start-up
- Trial Master File support
- Risk-based monitoring
- Vendor coordination
Data and scientific services
Traceable data, safety and scientific reporting work packages turn study activity into review-ready evidence.
- Data management planning
- eCRF design and data cleaning
- Biostatistics
- Statistical analysis plans
- Pharmacovigilance
- Medical writing
- Clinical study reports
- Publication support
Medical device and clinical technology services
EU MDR 2017/745 consulting and clinical evidence generation are aligned with ISO 14155 and scoped to the manufacturer's device and evidence needs.
- Clinical Evaluation Reports
- PMCF planning and reporting
- Clinical investigation support
- Regulatory strategy
- Risk management support
- Technical documentation consulting
- Cold-chain and environmental monitoring
- Sample and IMP chain of custody
- Technology vendor qualification
- Change-control and computer-system-validation scoping
Site equipment, quality and consulting
Operational support combines controlled site equipment services, quality systems and consulting for clinical research teams.
- Protocol-based equipment planning
- Rental sourcing and coordination
- Calibration and certificate tracking
- Quality systems and SOP development
- Audit and inspection readiness
- Clinical trial center setup