Smooth Drug Development – Patient registries – CRO in Russia, CIS and Baltic States

Patient registries

Patient registries are the projects for the following puposes:

  • Compare drug efficacy with other drugs of similar action spectrum
  • Prepare risk management plan while using therapy with targeted biological medicinal drugs
  • Assess capabilities to impact on previously untreatable chronic diseases
  • Collect information on drug efficacy in routine clinical practice
  • Analyze off-label drug administration in clinical practice
  • Make pharmacoeconomic analysis (which drugs are more frequently purchased by state clinics, patients, in which age group, etc.)
  • Analyze the reasons for patients being transferred to another treatment scheme, and analyze measures to avoid this
  • Assess, which concomitant therapy is used
  • Assess disease incidence in a region (epidemiology)
  • Make an analysis of anthropological data on drug usage
  • Analyze and assess quality of life of patients using certain therapy
  • Analyze and assess the balance between the acquired therapeutic effect, adverse effects, expenditures, and patients loyalty

We offer the following services within registry projects:

  • Definition of the programme goal, tasks and programme development
  • Document preparation
  • Site selection and management
  • Project coordination
  • Data collection
  • Data cleaning and analysis
  • Preparation of scientific articles, monographs, brochures and other documentation based on study materials and results

When conducting registries, use a special medical information system. The system has comprehensible Russian language interface; it operates on all popular browsers.

System scalability provides for capability to use it by a non-limited number of users simultaneously.

System safety is enabled by: 

  • Secure connection channel
  • Role safety system
  • Individual passwords
  • Regular archiving

Quality of entered data is enabled by:

  • Automatic control of the fields completed manually
  • Quality control of entered data
  • Control and record of all changes made into system (audit trail)
  • Possibility to close the system for further data entry on patient, site, visit

The system enables on-line reports. Data export is possible in popular formats, which is discussed with Customer on an individual basis. The system enables remote data monitoring. 

Moreover, we also conduct a specific type of studies – these are studies of drug / vaccine influence while used by pregnant women. The data is analyzed compared to the data obtained from non-pregnant women administering the product. 

In some cases, drug influence is studied also for the drug, which was used by a woman before her pregnancy and is continued to be used during her pregnancy. Later, possible drug influence on the delivered child is studied. Data obtained during such studies are used to expand the information on drug / vaccine influence during pregnancy.