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

Key Partners

Contact information

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