Clinical services for phase I-IV studies

DOKUMEDS provides services for ICH-GCP clinical trial projects, including International project management, and Contract and Finance management. More than 150 clinical trials had been performed under responsibility of DOKUMEDS covering wide range of therapeutic areas: cardiovascular diseases, oncology, pain, pulmonology, infectious diseases, pediatrics, diabetes, musculoskeletal disorders and other.

• ICH-GCP compliant clinical trials projects
• International project management (ISO 9001:2000). Contract and Finance management. Review of the proposal and budget, Institution/Investigator contract negotiation. Lawyer consultancy. Study payment management
• Study site management services. Pre-study. Initiation. Medical and scientific consultation throughout the study. Clinical Monitoring. Close-out. Experienced Clinical research coordinators
• Medical Monitoring and Medical review
• Study design. CRF and Data base design
• Biotechnology studies (medical devices)
• Non-inventorial studies
• Analysis and reporting
• Archiving