MDX Research
MDX Research is a full-service company providing support in clinical study design, site selection and management, regulatory affairs, clinical operations and biostatistics. We are located in Timisoara, Romania.
Locations
- Europe
Therapeutic Areas
- Cardiovascular
- Gastroenterology
- Hematology
- Neurology
- Obstetrics / Gynecology
- Oncology
- Ophthalmology
- Vaccines
MDX Research is an innovative, real-world data focused CRO located in Timisoara, one of Romania’s leading University cities. We are committed to design robust pragmatic trials and to focus on real-life effectiveness of new treatments. We are currently operating mainly in CEE Region. Our main activities include research concept design, project feasibility, medical writing, regulatory affairs, data management, biostatistics and project management. Our team of specialists are qualified professionals with extensive clinical research experience and wide-ranging clinical expertise, including regulatory, project management, medical writing, data management and biostatistics. MDX is the place to explore your research concept, to design a robust clinical study or to demand evidence applicable to real-life settings.
In terms of data management, we bring high-quality, large data from extended populations and different clinical settings. Our mission is making treatments and medical care more accessible to patients worldwide. MDX Research is conducting clinical studies for both marketed and non – marketed medicinal products following the provisions of the EU Clinical Trials Regulation no. 536/2014 and the standard of ICH GCP E6. Our expertise runs through the following therapeutic areas: Cardiovascular, Ophthalmology, Medical Oncology, Gastroenterology, Neurology, Gynecology, Vaccines and Immunology.
Over the past 5-6 years we have been working closely with pharma companies and innovative medical devices manufacturers, from the UK and EU to bring closer new therapies for patients in Romania. Starting with 2022, we developed a real-world evidence study for estrogen positive, HER2 negative patients diagnosed with breast cancer across Romania. It is the biggest patient platform capturing data related to clinical characteristics, diagnosis, treatment management, imaging, and subsequent therapy lines par patients treated for breast cancer over 2.5 years. As such, in 2023 MDX Research was rewarded with the distinction of Most Innovative Data-Focused CRO in Romania. Our organization is audited on a yearly basis on Quality Management and Information Security Management systems compliance leading to our ISO 9001:2015 and ISO 27001:2013 Certifications.