Department of Scientific Studies

The Department of Scientific Studies at the Institute of Interdisciplinary Medicine began its work in 2015.

The Department specializes in designing and conducting various kinds of clinical trials and post-marketing surveillance. This work includes:

• implementing pharmacovigilance in accordance with each client’s needs

• compiling and maintaining patient registers

• monitoring changes to local regulations pertaining to pharmacovigilance, in Russia, the European Asian Economic Union (EAEU) and the former Soviet Republics (CIS)

• monitoring print and media sources for signal detection

• establishing reporting mechanisms for Adverse Event (AE) incidents, including a hotline

• pharmacovigilance data collection and document production

• providing a Qualified Person for Pharmacovigilance (QPPV) and his or her deputy

• and other services as needed.

Additionally, the Institute of Interdisciplinary Medicine is prepared to work in full support of the Department and its clients.

The Department of Scientific Studies has close ties with the Association of Interdisciplinary Medicine and its nearly 20,000 members. We also work closely with Patient Associations.

The Department of Scientific Studies has well-established partnerships with clinical research sites in more than 30 cities located in all regions of the Russian Federation – from Murmansk to Krasnodar, from Kaliningrad to Vladivostok.

Our team at the Department of Scientific Studies is a team of professionals drawn from a wide range of medical fields and the pharmaceutical industry.

Our guiding principles: the highest standards of quality and business ethics

	Vladimir Andrianov – «Director, Department of Scientific Studies» +7 (929) 647 26 01 E-mail: andrianov@idm.institute Vladimir Andrianov has 10 years’ experience in clinical research. Before joining the Institute of Interdisciplinary Medicine, he worked for some of the largest international clinical research organizations and pharmaceutical companies. He has comprehensive experience as a monitor and manager in 30+ clinical trials, including experience with site selection and close-outs, managing budgets, preparing and conducting audits of testing sites, preparing and conducting audits of local and central master files, preparing for regulatory review, pharmacovigilance. Dr. Andrianov has work experience in various medical specialties, including oncology, cardiology, dermatology, neurology, rheumatology, endocrinology, psychiatry and radiology; and in various phases of clinical trials. He has excellent knowledge of ICH-GCP, Russian and international regulations pertaining to clinical research. He underwent training in Russia, England, Switzerland, Netherlands, Germany, Denmark and Spain in organizing and conducting clinical research. Education: graduated from I.M. Sechenov First Moscow State Medical University in 2006 with a degree in Medicine, with honors. Languages: Russian, English Member of the Research Quality Association since 2015
	Irina Kozulina – «Manager, Department of Scientific Studies» +7 (929) 904 42 05 E-mail: kozulina@idm.institute Education: Irkutsk State Medical University School of Medicine  Irkutsk State Linguistic University, with a major in English and English translation Irkutsk State Institute of Advanced Training for Physicians, Residency in Allergy and Immunology Candidate of Medical Sciences, Allergist-Immunologis Dr. Kozulina has more than 10 years’ clinical work experience in hospitals and private clinics Languages: Russian, English Member of the Russian Association of Allergists and Immunologists; and the European Association of Allergists and Immunologists
	Margarita Svishcheva – «Authorized Person for Pharmacovigilance» +7 (910) 430 08 90 E-mail: svishcheva@idm.institute Graduated 2008 I.M. Sechenov Moscow Medical Academy, followed by residency in Neurology Graduated 2012 M.V. Lomonosov Moscow State University, School of Business Administration Work experience: 2009 - 2011 Worked in a contract research organization as a coordinator of clinical trials. 2011 - 2016 Executive Director of a contract research organization. Conducted clinical trials. Implemented pharmacovigilance. Designed medical documents, including investigative brochures, protocols and informed-consent forms. Worked with the local Ethics Review Board and the Ministry of Health, Roszdravnadzor. 2016 – 2017 Specialist in pharmacovigilance Since 2017 Authorized Person for Pharmacovigilance at the Institute of Interdisciplinary Medicine Languages: Russian

Advantages we offer

Uniquely comprehensive knowledge and experience conducting clinical trials, including:

• organizing and managing various kinds of post-marketing surveillance

• organizing and conducting meetings in Russia and abroad

• producing “turn-key” studies – from preliminary discussions to presentation of the final report

• employing an interdisciplinary approach to research

In-house ethics review board

Quality control system – the Department of Scientific Studies works with a single, defined set of Standard Operating Procedures

The Department has experience organizing meetings between researchers in various formats, such as symposiums, congresses and online conferences.

The Department of Scientific Studies has close ties with the Association of Interdisciplinary Medicine and its nearly 20,000 members. We also work closely with Patient Associations.

We offer flexible payment plans that allow our clients to better manage their research and development budgets.

Features

The department of Scientific Studies has well-established partnerships with clinical research sites in more than 30 cities across Russia. The doctors that participate in our trials are leading authorities within their regions and disciplines.

The Department uses the latest in IT technology to manage our clinical studies.

The Department of Scientific Studies has the capability not only to organize and undertake clinical trials, but to provide our customers with these additional services:

prepare and present a statistical analysis of the results of a study

prepare a report detailing the results of a study

publish materials related to a study in appropriate professional journals

In addition, the Institute can offer the Department’s clients related services within the framework of pharmacovigilance:

• monitoring print and media sources
• prepare local and central Master Files for pharmacovigilance
• write SUR
• provide a Qualified Person of Pharmacovigilance and his or her deputy
• professional training in clinical trials and pharmacovigilance

Our partners

Genzyme	Pfizer	World Medicine	Rompharm	Biotehnos	Ferrer