The research group established in 1991, based on privately owned medical or clinical research professionals has shown over 20 years’ experience of clinical trials conduct and clinical project management. The consultancy business managed by MEDIX group has gradually expanded to a network of clinical research partners and academic professionals covering multiple therapeutic areas, providing a solid base for scientific approach and consultancy in clinical research and study management.
MEDIX managed to establish one of the clinical research consultancy and services hubs in Hungary first and then expanded to the Central- and Eastern European region and in 2014 established legal entity and operation in Russia. MEDIX offers personalized attention in strategy and the needs in medical concepts, in early phase trials, as well as high quality in services during the conduct of late phase trials. We aim to provide individually tailored support and the delivery within the time and budget constraints.
Within the group of Research Network Partners (MEDIX RNP) we utilize qualified professionals in clinical study conduct and data management/ biostatistician services (certified Research Partner) to ensure quality in data collection and reporting according to ICH-GCP guideline and quality measures. Overall, our business philosophy is based on the highest respect to patient’s safety and individual data protection right in accordance to country regulations
Mission: to provide quality service across Central and Eastern Europe
Medix Clinical Services is specialized to support pivotal and proof of concept projects and mid- sized trials mainly with a specific or advanced scientific values or level of complexity. Our clients range from small emerging academic research groups to mid-sized pharmaceutical and biopharmaceutical companies, medial device companies.
Within the project teams utilizing the established network partners that based on centralized project management and the same SOP structure. We bring the country level expertise to daily problem solving process. Our work, our results provides confidence supporting specific needs of drug development program expectations across the EU countries and also in East European region.
Clinical Trials Services
We offer high quality of services tailored individually for the clients and projects to support the delivery on time and reasonable efforts with reliable budget. Our 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.
Our operational success based on Research Network Partners, the locally registered clinical monitoring/services and affiliated academic consultants. The networking partners should have at least the seniority level local regulatory and monitoring experience within their country, respectively.
We are confident to offer services of
- Feasibility and Start-up guidance
- Country specific feasibility studies, site qualification for selection as required,
- Therapeutic specialists, KOL consultation
- Regulatory (MoH) and Ethics (CEC, MEC, LEC) submission in CEE countries,
- Global or Regional Clinical Project Management
- Clinical Monitoring and data QC
- Study Coordination at site level
- Consulting for Safety Management
The regional clinical operation services have been successful in managing and conducting multicentre and multinational Phase-II /Phase-III studies, but also provide a capacity to manage full service in Bioequivalence trials. Utilizing the Multifactorial approach* for patient enrolment, during conduct and follow-up phases.
Medical Writing Services and Consultancy
Our clinical operational team is supported by the group of medical writers comprises primarily MD/ PhD-level scientists who write and develop a wide range of documents for trial and marketing registration/regulatory purposes according to clients’ specifications.
MEDIX consultancy team and Local Knowledge Experts (LNE) is composed of Medix’ employees, subcontracted clinical experts and academic professionals as required for a specific fields. Our local knowledge experts (LNE) experience in regulatory and clinical trials services extended the coverage also to the EE and West-Balkan countries. The Clients of Medix are Academic Research centres, Pharma- or Biotech companies from EU and US, with the high respect of added scientific value.
Operational coverage includes the CEE region (Czech Republic, Hungary, Croatia, Poland, Slovakia and Slovenia) and Balkan+West-Balkan countries (Romania, Bulgaria, Greece and Turkey) and additional coverage for East Europe as of Russia, Ukraine, Belarus, Georgia.
The network of clinical research partners is based on locally registered Clinical Monitoring/Service providers or by certified Research Network Partners (RNP), that in each country listed represents at least 8 years of clinical trials and relevant regulatory experience and startup work as well as clinical monitoring.