About Us

Statandocs was founded in 2016 by a group of experts in clinical and preclinical trial of medicinal products. The main goal of the founders of the company at that time was to help the pharmaceutical industry in the preparation of 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, services in the field of medical writing - from the concept to the protocol and other essential documents of a clinical trial, statistical support from substantiating the sample scope to generating a report on the results of the study, preparing a dossier in the format of a common technical document (CTD) according to the requirements of the local legislation of the Russian Federation and in the format of the CTD according to the legislation of the Eurasian Economic Union (EAEU).

QUALIFICATION OF EMPLOYEES

Considering rapid changes in the regulatory environment both at the national and international levels, the company's employees are constantly trained at educational seminars and advanced training courses on the basis of the FSBI "NTSESMP" of the Ministry of Health of Russia, the FSBI "VNIIIMT" of Roszdravnadzor, the FSBI "National Institute of Quality" of Roszdravnadzor (formerly FGBU "TsMIKEE" of Roszdravnadzor), FBU "GILS and NP". 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 face-to-face contact. That's why Statandocs business leaders annually participate in key industry conferences and congresses, such as RegLec, PharmMedAppeal, Circulation of Medical Devices, International Congress on Clinical Trials for Medical Devices (CTMD), Adam Smith Institute International Forum "Clinical Trials in Russia", Asian Pharmaceutical forum, and in recent years as invited speakers and organizers of master classes, which constantly arises the interest of delegates.

ACTIVITIES

Development of the company and appearance of new areas of activity are directly related to the active participation of Statandocs in the life of the industry. Thus, with the entry into force of the Rules of good practice for pharmacovigilance 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 of pharmacovigilance system: a periodically updated safety report (PSAR), a safety report for a medicinal product under development (RSUR), risk management plan (RMP), pharmacovigilance system master file. Today the company employs certified experts in the field of pharmacovigilance, the documents prepared by them meet the strict requirements set by the experts of Roszdravnadzor, and in most cases are accepted without comment from the first submission. Due to the very serious attitude to information security, the company employs highly qualified specialists in the field of IT technologies. With the participation of experts from the IT department and specialists from Data management department, our own electronic IRC and IWRS services have been implemented, database development, data entry and validation, the formation of clarifying queries, and the smooth operation of databases containing information on tens of thousands of patients are provided. Statandocs is one of the first companies to offer a service for the preparation of an electronic CTD (eCTD) in accordance with the requirements of the EAEU. The eCTDs prepared by us have been validated and accepted by the regulatory authorities of the Russian Federation and the Republic of Kazakhstan. In 2019, a service was launched for writing SmPC, a leaflet and for conducting user testing of a leaflet, in particular, more than 10 user tests were carried out using telecommunication technologies during the period of restrictive measures in connection with the pandemic of a new coronavirus infection COVID-19.

OUR EXPERIENCE

Over 5 years of work, Statandocs employees have completed:

 - more than 2100 projects, including more than 500 INNs and more than 50 medical devices in all possible therapeutic directions.

 - 132 electronic IRCs (over 500 clinical centers, over 42,000 study participants);

 - 162 reports on the results of the study were successfully submitted for registration of medicinal products in Belarus, Kazakhstan, Russia and Ukraine

Over 400 expert opinions and consultations issued to support preclinical and clinical development of medicinal products and medical devices, including comparison of strategies and risk minimization plans (6 development programs were supported by us from the first study in humans to registration, including the development of original molecules)

Created and successfully submitted more than 30 electronic dossiers in eCTD format (XML EAEU) in Russia, Kazakhstan and Armenia

More than 900 documents as part of the clinical dossier have been created and successfully submitted to the regulatory authorities of Armenia, Belarus, Vietnam, Georgia, Kazakhstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine)

More than 1,500 sections of a common technical document in the EAEU format have been developed (our documents are accepted without comments!)

OUR ADVANTAGES

Focus on information security and business continuity: significant investment in IT infrastructure using well-known and validated software (Microsoft 365 for Business, Bitrix24, 1C, SAS, PASS) and wide use of cloud technologies with a reliable backup system. Our developers and system administrators have significant (more than 20 years) experience in database and software development, as well as information security;

Well-organized project management with clear and traceable deadlines, tasks and KPIs (using Bitrix24) ensures timely completion of work and high quality of documents and services;

Standardization of processes through the introduction of a system of quality management documents, multi-level quality control and the use of highly automated templates and IT solutions;

We are active and well-known members of the pharmaceutical community: Statandocs participates in all major events in the field of clinical trials as key speakers or partners, constantly trains employees at trainings and courses organized by regulatory authorities, fruitfully cooperates with the FSBI NCESMP as trainers, speakers, partners for program development.

STATANDOCS TODAY

Today, Statandocs is a multidisciplinary, diversified, dynamically developing company providing a wide range of services demanded by pharmaceutical industry. We have more than 80 employees, including the largest staff of medical writers in the region, we have completed projects for more than 90 customers in Russia and CIS, including large international ones such as Pfizer, AstraZeneca, Bayer, Takeda, Stada, Gilead, etc... and local (R-Pharm, Microgen, Akrikhin, Geropharm, Alium Group, ValentaPharm, Santo, Minskintercaps, Yuria-Pharm) pharmaceutical companies and CROs, the documents prepared by us have been successfully submitted to the regulatory authorities of Armenia, Belarus, Vietnam, Georgia, Kazakhstan, Moldova, Russia, Tajikistan, Uzbekistan and Ukraine. Statandocs is a reliable partner, we do not stand still, we are not afraid of complex tasks and we are always ready for productive cooperation.