200 professionals and top-notch specialists in clinical operations
Irina Petrova, MD
Clinical Operations Director
Deputy CEO for Business Development
Dmitry has a 15 years’ experience in clinical research. Eight years ago he has founded OCT company and since then has been successfully managing his business, having grown the company to the size of 100 employees in 2013. Dmitry holds a degree in HR management from the Financial and Economics Institute (St. Petersburg, Russia).
He is responsible for the establishment of the corporate vision and business strategy development.
Dmitry is married and has a son . In his free time, Dmitry enjoys yachting.
Anna has over 9 years of experience in clinical trials and is one of the first members of the OCT team. She joined the company in 2006 as an Office Manager and subsequently became a Contract Manager in 2008. Anna’s main responsibilities included drafting and negotiating contracts, maintenance of the company’s legal documents, and arrangement of legal support for OCT’s operations in the countries of its presence. In 2014, Anna was promoted to Deputy CEO for Business Development. In this capacity, Anna combines both administrative and partially business development functions. Her main administrative responsibilities are administration of legal issues, managing contracts and general supervision over the corporate operation and development in the USA, Russia, Ukraine, Bulgaria and Latvia. As a BD representative, Anna is in charge of client relations management.
As an exchange student during the final year of secondary school, Anna graduated with honors from a high school in the USA and continued her education in one of the best universities in Russia. Anna graduated from the Herzen State Pedagogical University of Russia in 2006 with a major in English Linguistics and an additional training course in enterprise management.
Andrey Stefashin, MD
Senior Project Manager
Andrey joined the OCT team in spring 2016. For the past 10 years he had been working in an international CRO where he participated in research projects across a variety of therapeutic areas, such as oncology and rheumatology, respiratory diseases, diseases of nervous and endocrine systems. Andrey regularly attended specialized trainings and completed his training course in Cambridge. His solid professional experience allows him to address various clinical research issues and make fast, competent and well-informed decisions in different kinds of situations. When achieving set goals, he puts sponsors’ interests first and always strives to provide high-quality services. This is why Andrey is highly valued by his project team and study sponsors.
Andrey started his career in clinical research after graduating from the Smolensk State Medical Academy, Department of Therapy. During this time he also completed a residency program in radiology.
In 2010, Andrey completed his second university degree in management of organizations in the Smolensk Institute of Business and Entrepreneurship with a degree work on crisis management.
Acting Head of Business Development
Business Development Director
Business Development Manager
Olga graduated from Saint-Petersburg State University of Economics and Finance and took a marketing course at FernUniversität in Hagen, Germany. Olga is proficient in German and English.
Having started her career in clinical research as a project assistant in 2009, in six months she was promoted to a financial specialist and within the following 6 years Olga was responsible for grants calculation and budgeting as a part of the project management department in one of the global CROs. In March 2016 Olga joined OCT team as a business development associate. In September 2017, Olga was promoted to the position of Acting Head of Business Development.
Anna Yanaeva has graduated summa cum laude from the Baltic State Technical University "Voenmeh" where she has received a Master’s degree in International Industrial Management. She has also received an MBAE (Master of Business Administration and Engineering) diploma of the Bodø Graduate School of Business.
Having started her business career in a Russian IT group of companies as an international relationship associate and having grown into an international development manager, she has received a serious experience in business relations and has attracted good investments into the company.
However, after the two years of successful work Anna has made a decision to enter a new sphere to apply her skills and get new experience as a business development professional. She has joined OCT as a business development associate initially, and has grown into a business development manager within her first year in the company. She intends to grow further in OCT and prove herself as a valuable member of the team and a reliable partner for OCT clients.
As a business development manager Polina is responsible for customer base expansion, communication with prospective clients, building customer relationships as well as preparing commercial proposals.
She stepped into clinical research as a clinical trial coordinator, and took a business development role within her first year at OCT. Before finding the beloved industry, she had served as a project manager and executive assistant in different business areas.
Polina graduated from the Higher School of Economics, St. Petersburg in 2014 with a degree in corporate management. She also holds a degree in linguistics, translation and interpreting from the Herzen State Pedagogical University of Russia. She is proficient in English and German, and studied as an exchange student at the Carl von Ossietzky University of Oldenburg, Germany.
Roman Dyatlov, PhD
Roman Dyatlov is responsible for an array of tasks here at OCT ranging from the management of clinical studies including budgeting, start-up activities, vendor selection, site monitoring, staff training and assessment, study documents review and preparation, communication with clients and coordinating of clinical team activities. Roman Dyatlov started his work with OCT in 2008. His experience in international trials began in 1999.
Roman received his PhD in Biochemistry and was trained in the field of Public Health and Clinical Trials at Yale University and Medical College of Wisconsin.
Irina joined OCT in July 2016 as a qualified specialist with profound experience of working in CROs, big pharma companies (Janssen, pharmaceutical arm of Johnson & Johnson) and biotech companies (Amgen): approximately 7 years of monitoring and over 3 years of project management in cardiovascular, diabetes, diverse oncology and gynecology phase I-III studies.
As a project manager, Irina is responsible for clinical research organization and management from feasibility and bid defense to reporting (planning, development of study documents, vendor management, staff supervision and coaching, risk management). Strong attention to details, sense of urgency, excellent organizational skills and communicability allow Irina to deliver projects within proposed budget and timelines.
Irina graduated from the Moscow Pedagogic University with diploma in speech therapy and holds an MBA degree from the N. E. Bauman Moscow State Technical University. She also has a substantial background in practical medicine as a graduated nurse in intensive care and cardiac resuscitation.
Gatis Klaucans joined OCT Baltic office team in 2009 and he is based in Riga, Latvia. Gatis has graduated Riga Stradiņš University receiving Pharmacist’s Degree and Master in Clinical Pharmacy specialty. Previously worked as documentation specialist for Drug Marketing Authorization submissions and was involved in clinical trials field from 2007.
Gatis started his carrier in OCT as CRA and was promoted to Senior CRA followed by Project Manager’s position from 2014. His scope of responsibilities is international clinical studies management in the Baltic States, Russia and Ukraine.
Clinical trials experience includes phase I, II and III studies in oncology, neurology, surgery, dermatology, ophthalmology and pulmonology covering the whole clinical trial lifecycle starting from protocol and budget development till the preparation of clinical trial report.
Innokentiy Lovyagin, MD
Denis Matsavey, MD
Lev joined OCT in 2013 as CRA and was promoted to SCRA in 2016. He subsequently worked at the same position for a CRO where his responsibility included monitoring of patient enrollment, data base lock, local teams, etc. At the moment Lev holds the position of project manager at OCT.
He is experienced in international and local phase II and III studies in different therapeutic areas, such as oncology, gastroenterology and rheumatology. These projects gave him valuable expertise in monitoring clinical trials.
Lev regularly attends trainings arranged both by OCT and sponsors to maintain his knowledge of clinical research procedures, ICH GCP and other therapeutic fields. He also takes individual online courses.
Lev has graduated summa cum laude from the Saint Petersburg State Chemical Pharmaceutical Academy and successfully completed his internship program. During his study, Lev was a Nycomed scholarship winner and participated in a student exchange program.
Innokentiy joined OCT in 2010 as a Clinical Research Associate. He was promoted to a Senior Clinical Research Associate in 2013 and became a Project Manager in 2015. He is responsible for all relevant tasks among which are project planning, budgeting, building and managing of the project team, organization and conduct of meetings and trainings, start-up activities, vendor selection, co-monitoring, working with study documents, communication with clients and coordinating of clinical team activities.
Innokentiy graduated from St. Petersburg State Medical University with an MD degree in 2007 and was qualified in surgery in Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine in 2008. He completed residency training in traumatology and orthopedics in R. R. Vreden Russian Research Institute of Traumatology and Orthopedics in 2010.
Denis graduated from the Military Medical Academy in Saint Petersburg and started his career in clinical research after 1.5 years of work as head of therapeutic department and internist.
Denis joined the OCT team in summer 2017. For the past 10 years, he had been working in international CROs, where he participated in different research projects across a variety of therapeutic areas such as oncology, hematology, pulmonology, cardiology, neurology and endocrinology. His extensive professional experience allows him to handle various clinical research issues and make fast and competent decisions in complex situations. Denis have gained expertise in international research and managing trials in such countries as Russia, Belarus, Bulgaria, Romania, Hungary, Turkey, South Korea, Germany, UK, Slovakia, Croatia and Czech Republic.
In 2015, Denis completed his project management training course based on PMBOK Guide.
Julia Stepanchuk, MD
Clinical Operations Manager
Vladimir Donets, MD, PhD
Senior Clinical Research Associate
Julia joined OCT in September, 2014. Previously, she has been working as a clinical trials manager in a pharmaceutical company. As a project manager, Julia is responsible for clinical project management including study initiation, ongoing monitoring, and close out activities, vendor selection, budgeting, review and preparation of study documents, staff training and support.
Julia has been working in clinical research since 2008. She participated in trials of various therapeutic areas including oncology, neurology, gynecology, psychiatry, ophthalmology, etc., as well as in phase I clinical trials in healthy volunteers and in bioequivalence trials.
Julia graduated from the Burdenko Voronezh Medical Academy, Faculty of General Medicine, with a degree in general medicine. She also completed a residency program in psychiatry in the St. Petersburg Psychoneurological Research Institute, where she started working as a psychiatrist in 2008.
Maria Anisimova joined OCT as a Clinical Trials Coordinator in 2008. Maria graduated from Saint Petersburg State University with a Master’s degree in Linguistics, Translation and Interpreting.
As a Clinical Trials Coordinator, she participated in numerous clinical studies where she performed a wide range of coordinator’s activities within start-up, ongoing and close-out phases of trials. Then Maria was promoted to a Senior Clinical Trials Coordinator and was delegated with the function of other CTCs’ supervision as well as their training and day-to-day maintenance.
In 2016 Maria became a Clinical Operations Manager whose main objective consists in hiring, appropriate training, adequate assignment to projects and regulatory assessment of OCT Clinical Department personnel in accordance with applicable corporate procedures.
Vladimir joined OCT as a clinical research associate in 2011 and was promoted to a senior clinical research associate in 2014. As a leading clinical research associate, Vladimir is involved in project coordination and all activities related to communication with investigational sites, reporting, and searching for new potential study sites. He is also responsible for monitoring visits, training visits for CRAs, review of monitoring visit reports, maintenance of study-specific documentation, etc.
In 2006, during his study at the Mechnikov North-West State Medical University, Vladimir started participating in clinical trials in different therapeutic areas as a co-investigator. Working at OCT, Vladimir expanded his professional experience and now has an in-depth knowledge of clinical trials in various therapeutic areas such as oncology, endocrinology, internal diseases, rheumatology, neurology, surgery, cardiology, etc.
Vladimir graduated from the Medical Department of the Petrozavodsk State University with an M.D. degree and is qualified in therapy. He also holds a Clinical Pharmacology Certificate. Vladimir completed his internship, clinical residency and postgraduate training program at the Mechnikov North-West State Medical University. In 2014, Vladimir successfully defended his thesis on internal diseases and microbiology.
Igor Luchinkin, MD
Senior Clinical Research Associate
Senior Clinical Trials Coordinator
Igor has a 11 years’ experience in clinical research industry. Prior to joining the company, Igor served as CRA and Senior CRA at global CROs. He has a monitoring experience in phase I-III clinical trials in various areas including allergology, endocrinology, ophthalmology, cardiology, rheumatology, nephrology, oncology, neurology, urology, respiratory and pregnancy anemia.
Igor graduated from the Russian State Medical University with M.D. degree. Igor also worked as a surgeon at a clinical hospital in Moscow in 2001-2005.
Sergey joined OCT as a senior clinical research associate at the beginning of 2016. His current responsibilities include full cycle of monitoring, investigational site selection, CRA trainings, co-monitoring visits, supervision of CRAs, and other project management-related activities.
Sergey has been working in clinical research since 2011. He has gained vast experience in various therapeutic areas, such as cardiology, endocrinology, oncology, neurology, rheumatology, nephrology, psychiatry, phthisiology, and urology. He was involved in bioequivalence studies, phase III- IV studies as a CRA and project manager. Apart from practical experience, Sergey constantly refines his theoretical knowledge by attending different training courses in GCP, project management, site quality and efficiency improvement, monitoring, as well as other project specific trainings.
Sergey graduated from the Dmitry Mendeleev University of Chemical Technology of Russia with a degree in chemical technology of synthetic biologically active substances.
Anastasia joined OCT in February 2017 as a clinical trials coordinator and was promoted to a senior clinical trials coordinator two years later.
In addition to project coordination Anastasia is in charge of management, supervision and control of all the coordinators within OCT. She also provides trainings on SOPs and TMF maintenance according to the ICH GCP.
Having more than 10-year experience as a clinical trials coordinator, Anastasia has been successfully coordinating different projects in various therapeutic areas such as oncology, hematology, neurology, dermatology and pulmonology.
Anastasia graduated from the Herzen University with a major in English language having spent one year as an exchange student at the University of South Iowa, USA. She put her knowledge and skills in the field to practice while working for various American companies.
Ekaterina Andrianova, MD
Ekaterina Andrianova provides project support as a Pharmacovigilance Specialist and takes part in all pharmacovigilance activities both in clinical and post-marketing studies. Ekaterina may act as a Qualified Person in Pharmacovigilance (QPPV).
Ekaterina joined OCT team as a Safety Associate in 2014 and was subsequently promoted to a Pharmacovigilance Manager. Her clinical trial experience goes back to 2009, when she started as a Drug Safety & Package Insert Specialist. Ekaterina has a solid experience across both post-marketed and clinical trial products pharmacovigilance in a wide range of therapeutic areas.
She graduated with honours from the I. M. Sechenov First Moscow State Medical University, Faculty of Medicine, where she subsequently took an internship in neurology and completed postgraduate training program in neurology and psychiatry. Ekaterina also completed training in clinical residency in A.Ya. Kozhevnikov Clinic of Nervous System Diseases (neurology). She was awarded with a PhD degree in neurology and psychiatry in 2013.
Oleg Efimov, MD, PhD
Vladimir Chistyakov, MD, PhD
Eugenia Radkova, MD, PhD
Oleg has been working in OCT since 2015.
He is responsible for writing all types of medical documents for regulatory submissions and for development of clinical study designs, sample size estimation, preparation of clinical study protocols, investigator’s brochures, subject information leaflets, clinical study reports as well as scientific articles for medical journals in Russian and English. Oleg has experience in such therapeutic areas as gastroenterology, cardiology, endocrinology, pulmonology, neurology and dermatology.
Oleg graduated from Russian Military Medical Academy, holds a PhD in Medicine and has a strong educational and research experience in internal diseases. He is an author of scientific papers and a member of the European Medical Writers Association (EMWA).
Eugenia Radkova has been working in OCT since 2013. She is responsible for providing expert review and advise on all matters related to scientific methodology and clinical study design, development of a full set of medical documents (study protocol, informed consent, Investigator’s Brochure, clinical study reports) for clinical studies in various fields of medicine. Eugenia has a solid expertise both in interventional I-IV phase studies and observational epidemiological studies and programs.
Eugenia graduated with honors from the Mechnikov St. Petersburg State Medical Academy and is a holder of a scholarship from the Russian Government and the St. Petersburg Governor. She holds a PhD in Medicine and has a strong educational and research experience in pharmacology and preventive medicine. During her work in academic sphere she has published more than 50 scientific papers and took part in research projects as a co-author and co-investigator under government contracts and Russian federal target programs.
Extensive research experience and knowledge in medicine and pharmacology allow Eugenia to successfully address all issues related to drug development and clinical trials conduct. She is a member of EMWA and AMWA professional associations. She improves her professional skills in medical and regulatory writing, biostatistics, methodology and design of clinical trials on a regular basis through training courses conducted by Russian regulatory organization Scientific Centre for Expertise of Medical Application Products and foreign educational institutions (Harvard Medical School, Stanford University and others).
Eugenia is involved in a training programme for OCT clinical staff and is an experienced speaker at various educational events organized by the Skolkovo Innovation Centre and conferences arranged by OCT which gather a wide range of healthcare professionals every year.
Andrei has been working for OCT since 2017. Far Eastern State Medical University Pharmaceuticals Department graduate, he is a member of the European Medical Writers Association (EMWA).
Andrei is responsible for writing all types of medical documents for regulatory submission and for the development of clinical study designs, sample size estimation, preparation of clinical study protocols, investigator’s brochures, subject information leaflets, clinical study reports. Andrei has experience in such therapeutic areas as gastroenterology, gynecology and rheumatology.
Tatiana Goriushkina, PhD
Natalya has over 7 years of experience in clinical trials. She joined OCT in 2011 as an Office Manager with a responsibility to be in liaison with Regulatory Department and assist them in running of submissions to Regulatory Authorities. Subsequently became a Regulatory manager in 2014 and was promoted as Senior RM early in 2018. In this capacity, Natalya coordinates the work of regulatory department, ensures that trials are carried out in accordance with applicable legislation and regulations, makes sure that all applications and other information and materials required for submission to Regulatory Authorities meet all applicable requirements and prepared in accordance with the highest quality standards and OCT strategy. Natalya also contributes to the development and improvement of departmental procedures and processes.
Natalya holds the Diploma of the Institute of International Trade and Law, Moscow. She is also a regular participant of conferences and training programs in pharma field.
Tatiana Goriushkina joined OCT in 2014 when a new service, state registration of drug products in Russia, was proposed by OCT to its clients. Tatiana graduated from Taras Shevchenko Kiev National University as a Master of Biology. She received her PhD in Biotechnology at the same University.
Before entering the sphere of drug products registration, Tatiana worked as a scientist in scientific-research institute. Her field of interest was development and optimization of enzyme biosensors, portative devices for quantitative analysis of wide range of substances. Later she worked as a Leading chemist-analyst in R&D department of pharmaceutical company.
Since 2012 Tatiana has been working in the field of drug registration. She is experienced in dossier preparation for state registration of drug products in Russia, including registration of bioanalogues.
As a registration manager at OCT, Tatiana evaluates and reviews documents of the technological part of registration dossier, prepares full set of documents for the pharmaceutical part and is responsible for final registration dossier preparation and submission.
Maksim Kulunchakov, MD
Head of Quality Assurance Department
Quality Assurance Associate
Prior to his joining OCT, Maksim worked in one of the public hospitals of St. Petersburg. He joined OCT in February 2013 as a Clinical Research Associate and 2 years after was promoted to a Quality Assurance Manager. In 2018, Maksim became the Head of Quality Assurance Department. He is involved in all QA activities, including internal and external audits, quality checks of study documents, addressing of QC issues, personnel and external trainings, etc.
Maksim graduated from the Pavlov First Saint Petersburg State Medical University in 2010. He has a Medical Degree and is qualified in neurology.
Since 2015 he has been an associate member of the RQA (formerly BARQA). As an OCT representative he participates in international QA events all over the world, including in Asia, Europe and Russia.
Ivan graduated with honors from the Military Medical Academy in 1999 and completed medical internship in 2000 with a major in General Surgery. In 2002 he obtained another degree in law having graduated from the High School of Economics. In 2007 Ivan earned his Ph.D title.
Having gained vast experience working for Russian and international CROs since 2012, Ivan joined the OCT team in 2018 as a Quality Assurance (QA) Associate. His area of responsibilities includes quality checks of study documents, internal and external audits, personnel training and other related activities of the QA department.
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