At DeSia, we support you in planning, conducting, and documenting clinical studies for both medical and in vitro diagnostic devices. Our services ensure full alignment with ISO 14155, ISO 20916, ICH-GCP, MDR, and IVDR requirements—supporting regulatory approval, clinical performance validation, and post-market follow-up.
What We Offer
Clinical Study Strategy and Documentation
- Development of tailored clinical research strategies and protocols
- Preparation of ethics committee and competent authority applications
- Preparation of essential study documents: Investigator Brochure (IB), Case Report Form (CRF), and Informed Consent Form (ICF)
Clinical Study Execution
- Project management and coordination with investigators and hospitals
- Management of all regulatory communications and follow-up
- Full oversight of clinical study budget, logistics, and timelines
Data and Monitoring Services
- Electronic Data Capture (EDC) system design and management
- Clinical Data Management and final data reporting
- On-site monitoring for protocol and data compliance
- Setup and coordination of Clinical Event Committees (CEC)
- Independent audits to ensure GCP, MDR/IVDR and standards compliance
Trial Master File (TMF) Services
- Preparation, management, and ongoing updates of the TMF throughout the study lifecycle
- Document control in accordance with global clinical research standards
Need support with your clinical study? Book your complimentary initial consultation.