Roman has more than 10 years experience within the clinical trials area, recently was acting as Medical Trials Quality Assurance Manager in STADA CIS. He started his career working as Sub-Investigator and continued as CRA in local and international CROs. Before STADA Roman worked as CRA, Senior CRA, Clinical Team Leader and has solid experience mainly in oncology, cardiovascular, psychiatry, rheumatology, neurology, urology, pediatrics and general therapy areas. Systems within his responsibility/area of expertise are: supplier qualification, inspection management, personnel training, internal quality system documentation maintaining, SOP management, risk management, internal and external audits (GCP/GMP, certified as GMP auditor in 2018).
At the moment Roman is working as a Clinical Trial Quality Assurance Manager at Drugs Technology (R-Pharm group of companies)
Dr. Aleksandr Solodovnikov has 14 years of clinical trial expertise as an investigator, CRA, clinical operations trial lead and clinical operations manager in fields of Endocrinology, Psychiatry, Cardiology, Pulmonology, Oncology, Hematology, Dermatology, Neurology, Surgery and Infectious Diseases (more than 30 trials, phase I-IV).
Aleksandr graduated from the Ural State Medical Academy (now University) in 2003 and started his scientific career at the Chair of preventative and family medicine resulting in a PhD in Rheumatology in 2009. Dr. Solodovnikov is now an associate professor of this Chair supervising edivence-based medicine and biostatistics fields. Aleksandr received his training in statistics and epidemiology at the University of Manchester, UK, and at the Erasmus University, the Netherlands, and personally prepared and conducted more than 300 various statistical analyses in various statistical software packages (NCSS, Stata, R, SPSS, Statistica and other) and provided a lot of consultations in this field. He further developed his professional skills in clinical research by taking the “Principles and Practice of Clinical Research” course at Harvard Medical School in 2014. In 2016, Aleksandr also successfully completed the “Project Management Professional”.
Dr. Solodovnikov is a skillful trainer and lecturer, and has conducted numerous GCP trainings as well as seminars in biostatistics, evidence-based medicine, clinical research, drug development and regulations in clinical trials. He knows local, regional (EAEU) and international clinical trial regulations and guidelines well, and took part in the development of hundreds of clinical trial documents for medicines, medical devices, cosmetic and dietary products, and biologically active substances, starting from study concept and ending with the final protocol.