Statandocs - Advantix Pharma Online Events

Statandocs was founded in 2016 by a group of experts in the field of clinical and preclinical trials. The main goal of the founders of the company at that time was to help the pharmaceutical industry in preparing high-quality clinical and registration dossiers of medicines. Since the beginning of its activity, Statandocs specialists have provided consulting services on the optimal drug development strategy, medical writing services - from concept to protocol and other essential documents of a clinical trial, statistical support from substantiating the sample size to generating a report on the research results, preparing a dossier in a common technical document (CTD) according to the requirements of the local legislation of the Russian Federation and in the CTD format according to the Eurasian Economic Union (EAEU) legislation.

EMPLOYEES QUALIFICATION

Taking into account the rapid changes in the regulatory environment both at the national and international levels, the company's employees are constantly trained at educational seminars and refresher courses at the FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation, FSBI "VNIIIMT" of Roszdravnadzor, FSBI "National Institute of Quality" of Roszdravnadzor (formerly FSBI CMIKEE of Roszdravnadzor), FSI SID and GP. Effective and most useful work for our customers is impossible without understanding the pressing problems that pharmaceutical companies face on a daily basis, without exchanging experience with colleagues and representatives of the regulator in the process of real-life communication. Therefore, the company line-of-business owners annually participate in key industry conferences and congresses, such as RegLek, PharmMedOverview, Circulation of medical devices, International Congress on Clinical Trials for Medical Devices (CTMD), the Adam Smith Institute International Forum "Clinical Research in Russia", the Asian Pharmaceutical Forum , and for the last two years as invited speakers and organizers of master classes, invariably arousing the interest of delegates.

ACTIVITIES

The active participation of Statandocs in the life of the industry is directly related to the development of the company and the emergence of new areas of activity. So, with the entry into force of the Rules of Good Pharmacovigilance Practice of the EAEU and the orders of the national regulator based on these rules, since 2017, there has been a growing demand for the preparation of high-quality documents for the pharmacovigilance system: a periodic safety update report (PSUR), a development safety update report (DSUR), a risk management plan (RMP), a pharmacovigilance system master file. Today, the company employees certified specialists in the pharmacovigilance, the documents prepared by them meet the strict requirements of the Roszdravnadzor experts, and in most cases they are accepted without comment from the first filing. Due to a very serious attitude towards information security, the company employees highly qualified specialists in the field of IT technologies. With the participation of experts from the IT department and specialists from the Data management department, we have implemented our own electronic CRF and IWRS services, ensure the development of databases, data entry and validation, the formation of clarifying queries, and the uninterrupted operation of databases containing information on tens of thousands of patients. Statandocs is one of the first companies to offer a service for the preparation of an electronic CTD (eCTD) in accordance with the EAEU requirements. The prepared eCTD have been validated and accepted by the regulatory authorities of the Russian Federation and the Republic of Kazakhstan. In 2019, a service was launched to write the SmPC, the package leaflet and conduct user testing of the package leaflet, in particular, more than 10 user tests were carried out using telecommunications technologies during the period of restrictive measures in connection with the pandemic of the novel coronavirus infection COVID-19.

OUR EXPERIENCE

For 4 years of work, Statandocs employees have completed more than 900 projects. Huge experience has been accumulated in the field of scientific and regulatory medical writing, examination of preclinical and clinical dossiers, including with the preparation of legally significant conclusions; 6 development programs, including the development of original molecules, have been accompanied by us from the first human research to registration. The high qualifications of Statandocs specialists are recognized by experts from the regulatory bodies of the Russian Federation and the EAEU, which is confirmed by the inclusion in the working group that prepares guidelines on the statistical aspects of clinical trials. Leading experts of Statandocs conduct trainings and seminars, as well as webinars in all areas of the company's activities. Our employees took part as invited lecturers in certification educational cycles on the examination and registration of medicines, good clinical practice, organized by the FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» , as well as in the development and conduct of the course "Documents of clinical trials of drugs" on the basis of the I. M. Sechenov first Moscow State Medical University with the issuance of state-recognized certificates.