Clinical trials and services (CTS)
MEDIX Clinical Services specialises in clinical services to support mini and medium-sized trials mainly for specific customer requests or advanced complexity. We offer quality services tailored individually for the clients and projects to support the delivery on time and reasonable efforts with a reliable budget.
We have skills gained from many years of experience in preclinical research and clinical trials; thus, we have created a flexible range of services that work as comprehensive consulting or clinical trial services across the development phases. We are 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 involves locally registered Clinical Monitoring/Service providers and Consultants. Most partners hold an established local regulatory and monitoring team/experience within their country, respectively. The networking partners as individuals should have at least the seniority level over eight years in each country.
The consultancy team comprises employees, subcontracted clinical experts and academic professionals. Teams are extended with subcontracted KOLs, as required for a specific field. We provide the CVs and list of the referred individuals upon request.
Extended Trial Support Services (xTSS)
Design and ready to use EDC, Data Management and CDC (by ISO 9001/2000) certified partner
Sample size estimates and complete Statistics/Reports (by certified biostatistician)
Pharmacovigilance services (EUDRA-PHV certified partner)
Manufacturing of placebo, packaging and labelling 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 a RUS based partner