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Staff

Staff

Our team consists of specialists with over 10 years of experience in the clinical research market. Our specialists have experience in conducting various types of clinical trials in different nosologies. The project team is always formed taking into account the experience of our employees in relation to a specific study. If necessary, we have the opportunity to attract additional qualified personnel to solve large-scale tasks. We are a friendly, cohesive team that ensures a high level of efficiency of our work and the creation of a worthy competitiveness of the company in the market.

КИО AX CT — клинические
исследования
любой сложности и
масштаба

Предоставляем полный спектр услуг по организации и проведению клинических исследований, включая исследования биоэквивалентности и всех фаз — от I до IV, а также неинтервенционные и пострегистрационные исследования.

Предлагаем как комплексные решения, так и отдельные виды услуг, чтобы обеспечить быстрый и экономически выгодный вывод лекарственных препаратов на рынок.

Работаем в России и за рубежом, предоставляем всестороннюю квалифицированную поддержку на каждом этапе. Тесно сотрудничаем с клиническими центрами, прошедшими инспекции Росздравнадзора и международные аудиты.

Сопровождаем процесс на всех этапах — от планирования до получения регистрационного удостоверения.

Выбирая нас, вы получаете результативный подход к каждому клиническому исследованию, а также оперативный запуск препаратов в обращение

Leadership

Khokhlov Alexander Alexandrovich

General manager

Heads of departments

Pozdnyakov Nikolay Olegovich

Head of Clinical Research Department

A Candidate of Medical Sciences with more than 10 years of experience in clinical research. Has experience as a physician-researcher, study coordinator, clinical research specialist, and project manager. Currently, in the position of head of the clinical research department, she successfully coordinates the work of all departments of the company. Co-author of 4 monographs on preclinical and clinical research, 1 textbook on clinical pharmacology for students of higher educational institutions, 1 guide for ethics committees; 2 patents. Participated in the development of a strategy for registering original Russian molecules for the treatment of intestinal infections and viral diseases. As a medical writer, Nikolai has developed more than 200 packages of medical documentation and final reports. We also have experience in developing documents for studying biosimilar generic insulin preparations of different durations of action and documents for studying original biomedical cell products.

Sharonova Ekaterina Yurievna

Head of Project Managers Department

Has experience in clinical research since 2016. Ekaterina began her career as a clinical research specialist. Currently, he continues to successfully work as the head of the project managers department, ensuring proper conduct and documentation of the progress of clinical trials. Ekaterina’s previous many years of experience as an expert doctor and head of a department helps to build communication within the team, with customers, which has a beneficial effect on the progress and result of project activities, since without well-coordinated team work it is impossible to achieve success. Being a competent, demanding, flexible leader, he enjoys authority among colleagues and the respect of customers. Under the leadership of Ekaterina, more than 10 large projects of phases II-III of various nosologies, as well as more than 50 bioequivalence studies, have been successfully implemented. Some of the projects were carried out in difficult epidemiological conditions, which made it possible to develop skills such as quickly adapting the project to changing conditions, maintaining communication with the Customer 24/7, and completing the project in a short time.

Miroshnikov Aleksey Yevgenyevich

Head of Medical Department

He is a Candidate of Medical Sciences with more than 10 years of experience in clinical research. Co-author of 4 monographs on preclinical and clinical research, 1 textbook on clinical pharmacology for students of higher educational institutions, 1 guide for ethics committees; 2 patents. Has experience as a medical researcher, clinical center coordinator, clinical research specialist, project manager, and medical writer. Pedagogical and research experience at a medical university for more than 10 years. Availability of certificates in infectious diseases, therapy, clinical pharmacology. Participated in the development of a strategy for registering a number of original Russian molecules, developing the concept and conducting registration clinical trials of the main drugs for the treatment and prevention of the new coronavirus infection COVID-19 (remdesivir, favipiravir, molnupiravir, nirmatrelvir, immunoglobulin, vaccine). Co-author of online courses on GCP, GLP and GVP, “High Performance Liquid Chromatography”, as well as an online course for ethical committees “Relevance of organizing the activities of ethical committees in the Russian Federation”. Developer and co-author of work programs for students in the disciplines “Reparative medicine and cellular technologies”, “Modern methods of drug analysis”, “Medical biotechnologies”.

Dovzhenko Olga Valeryevna

Chief Accountant

Accounting experience is 20 years, of which 6 years Olga has held the position of chief accountant in the field of clinical trials, which ensures prompt and professional resolution of complex issues when creating and agreeing on contracts for conducting clinical trials. Olga provides comprehensive support to the Customer on financial issues throughout the entire study. Under Olga's leadership, audits and inspections have been successfully completed several times.

Sedov Denis Georgiyevich

Head of information direction

As the head of the information department, he is responsible for computer and technical equipment, as well as the validation of computerized systems. Denis has positive experience in automation of several clinical centers with the implementation of temperature monitoring systems and control of engineering systems.

Maslova Aleksandra Yuryevna

Head of Clinical Research Data Management

Alexandra has more than 4 years of experience in clinical research. Alexandra received higher pharmaceutical education and advanced training in the field of clinical research data management. She began her career as a data management manager and processed data from more than 50 projects of all phases of clinical trials on more than 15 nosologies, including COVID-19 and Post-Covid syndrome. She has developed more than 50 Individual registration cards of varying degrees of complexity, including the use of electronic randomization. As a manager, he coordinates the work of the department to ensure the full cycle of work with clinical trial data: from the development of an individual registration card to archiving the final database. Experienced in programming projects based on the EDC system of complex research questionnaires and scales, such as the SF-36 Quality of Life questionnaire, the Pittsburgh Sleep Quality Index (PSQI), and the MoCA scale for assessing cognitive functions.

Smirnova Nataliya Valeryevna

Head of Quality Assurance Department

In 2018, while still a student at the Faculty of Pharmacy at Yaroslavl Medical University, Natalia entered the field of clinical research as an assistant clinical research specialist. A few months later I took the position of specialist, then head of the department of CI specialists. Successful experience in monitoring research and managing the department has given Natalia the opportunity to take the position of quality manager in 2021 and optimize the quality management system. The company has implemented more than 50 standard operating procedures, covering the procedures of all services provided. The company's quality assurance department has passed more than 5 full-time qualification audits without any comments, filled out over 20 qualification questionnaires, based on the results of which the company was included in the list of approved suppliers of Customers. The acquired experience in monitoring research allows Natalia to use a risk-based approach when assessing the progress of research and conducting internal audits.

Razumov Andrei Igorevich

Head of Department of Clinical Research Specialists

Andrey’s path to clinical research began in 2020 immediately after graduating from the Yaroslavl Medical University, Faculty of Pharmacy. He started working as an assistant to a clinical research specialist, where for more than six months he learned the basics of the work process. As a CI specialist, he conducted more than 7 phase II-III research projects in areas such as neurology, ophthalmology, urology, infectious diseases, and drug studies for the treatment of COVID-19, as well as more than 15 bioequivalence studies. The department of clinical research specialists, headed by Andrey, is the main link between clinical centers and CROs in conducting research; the quality of the work of its employees directly affects the result. Currently, under Andrey’s leadership there is a department of more than 10 clinical research specialists who are successfully implementing projects.

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Система менеджмента качества

Система менеджмента качества

Все бизнес-процессы регулируются стандартными операционными процедурами. Всего их в компании более 50-ти. Благодаря этому, все операции и процессы идут чётко, последовательно и в срок. Вы всегда в курсе актуального статуса вашего проекта. Мы регулярно проводим внутренние аудиты для подтверждения соответствия качества требованиям компании.

Сплоченный коллектив

Сплоченный, сработавшийся коллектив

Выстроенная корпоративная культура с единым понятийным аппаратом. Каждый сотрудник чётко понимает свою зону ответственности и формат коммуникации. Отсутствие текучки кадров. Когда исследование идёт до 3 и более лет, очень важно обеспечить стабильность коммуникации между Спонсором и проектным менеджером, монитором и клиническим центром, так как коммуникация происходит почти ежедневно.

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Опыт работы с молекулами действующих веществ

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info@axct.ru Yaroslavl, square Truda, 1, office 703, 704
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