Проекты наноцентра

«Center for Cellular Technologies LLC»

Contract Research Organization

We perform the complete cycle of a clinical trial:

  • Writing of study documents (Clinical Study Protocol, Investigator Brochure, Informed Consent Form, etc.)
  • Translation of client’s study documents into Russian according to Russian standards
  • Study sites selection
  • Regulatory Authority submissions
  • Import of the study drug, study equipment, keeping and destruction of the study drug
  • Export of human biological samples to the central laboratory of a client
  • Service of certified Russian central laboratory
  • Study sites initiation. Control of recruitment. Monitoring
  • Medical Support of the study. Preparation of safety reports
  • IWRS, eCRF. Data management, statistical processing of study data
  • Quality Assurance. Regular GCP-audits
  • Data management, statistical processing of study data
  • Closure of the study on site level and country level

Monitoring of the Clinical Trials:

  • Risk-Based Monitoring;
  • On-site, remote and centralized monitoring;
  • Observation of AE/SAE/endpoint reporting.

We work in accordance with

Advantages

  • Developed infrastructure and Nanocenters network of the Fund for Infrastructure and Educational Programs (FIEP) - RUSNANO
  • A team of highly qualified professionals with extensive experience in the world's largest CRO
  • High level of digitalization and process control, application of advanced industry software (CTMS) and Risk Based Monitoring
  • Quality management system, corresponding to Russian and world standards (FDA)
  • Opportunity to invest in the development of promising drugs
  • Reduced research time due to operational interaction with regional research centers and medical institutions
  • Close cooperation with Russian and foreign partners around the world

Our Executive Team

Tatiana Rosseeva
Tatiana RosseevaCEO
Baruch College, City University of New York, Finance. Tatiana Rosseeva worked in the field of financial management, project management and marketing in Russia and in the USA.
Elena Aronova
Elena AronovaBusiness Development Director
Ryazan State Medical University, MD, PhD Belgorod National Research University, Strategic Management
Tatyana Kalyuta
Tatyana KalyutaClinical Research Director
Saratov State Medical University, MD, PhD. National Lead Monitor

Key Partners

Contact information

‎3, Lodygina Street, Saransk, Mordovian Republic, Russia, 430006
Tatiana Rosseeva
‎8(8342)333-063
Яндекс.Метрика