Clinical Trials Services (CTS)
MEDIX Clinical Services is specializing in clinical services to support mini and medium sized trials mainly for specific customer request, or advanced complexity. We offer quality services tailored individually for the clients and projects to support the delivery on time and reasonable efforts with reliable budget.
Skills gained from over many years’ experience in preclinical research and clinical trials, thus we have created a flexible range of services that work as a comprehensive consulting or as clinical trial services across the development phases. We confident to offer:
- Local and regional trial management, clinical project managements
- Feasibility and regulatory guidance for trials
- Therapeutic specialists, KOL consultation
- Regulatory guidance for regional trials
- Country specific feasibility studies, site selection
- Clinical study project management
- Clinical monitoring
- Study coordination at site level
- Consulting for rescue studies
The network of clinical research partners is based on locally registered Clinical Monitoring/Service providers and Consultants. The networking partners as individuals should have at least the seniority level over 8 years in each country. Most partners hold an established local regulatory and monitoring team/experience within their country, respectively.
Since the network of consultancy team is composed of employees, subcontracted clinical experts and academic professionals, upon needs that have been extended with subcontracted KOLs, as required for a specific field. The CVs and list of referred individual can be provided upon request.
Extended Trial Support Services (xTSS)
Additional to clinical operation and Regulatory /Startup consultancy MEDIX offer clinical trial supporting services via the established group of partners:
- Design and ready to use EDC, Data Management and CDC (by ISO 9001/2000) certified partner
- Sample size estimates and full Statistics/Reports ( by certified biostatistician)
- Pharmacovigilance services ( EUDRA-PHV certified partner)
- Manufacturing of placebo, packaging and labeling IMP storage, distribution, ( GMP certified manufacturing plant)
- Distribution of Clinical Trial materials, and regional vendor management, ( local vendors)
- Vendor management expanded to RUS and UKR ( via RUS based partner)