YOUR SOLUTION IN CLINICAL TRIALS

Who we are

Carpathian Research Group LLC is a privately-owned clinical research organization (CRO) supporting broad range of R&D activities for biopharmaceutical and medical device industry across Ukraine, Georgia, Moldova, Turkey, Romania, Bulgaria, Poland, Russia, Kazakhstan, Uzbekistan, Belarus and United Kingdom

We have ISO 9001:2015,  ISO 45001:2018 and 17100:2015 certifications

What we do

Our mission is to help our customers make most advantage of their operations in most attractive geographical area for clinical research!

We use inexpensive optimized local infrastructure and have low administrative expenditures yet providing high quality services. This approach gives our customers significant benefit to plan their expenses and to always stay within a budget!

Carpathian Research Group is clinical research organization focusing on 3 core directions of activity

CONTRACT RESEARCH ORGANIZATION

Management of Clinical trials

  • Feasibility and Start-up
  • Project management (from the initiation of the project until final delivery to Client)
  • Clinical monitoring (all types of visits)
  • Enrollment Management
  • Regulatory submissions (CA and IEC-IRB)
  • Notarized translation services (English-Ukrainian-Russian) for trial and non-trial related documents
  • Risk Management and development of mitigation plans/strategies
  • Client support in finding of local clinical trials vendors (storage of trial-related materials, translation of clinical trial materials etc)
  • Consultancy services for Clients who wish to expand their services to Ukraine and neighboring countries.
  • Pharmacoeconomic and pharmacoepidemiologic studies

Medical Support

  • Development of study documents (protocol, questionnaires, ICFs, etc); medical support in CRF design
  • Medical liaison with Key Opinion Leaders, investigators, authorities
  • 24/7 medical information support on protocol, compound and safety issues
  • Trial-related medical data review
  • Reconciliation of safety events (SAEs, AEs of special interest)
  • Risk Management and development of mitigation plans/strategies
  • Tracking and distribution of safety reports (SUSARs, CIOMS)

Clinical Logistics

  • Customs clearance of IMP and clinical supplies
  • Local distribution to clinical sites

Health-care Site Management Organisation

Site Supportive Service

  • Support of Health Care Institutions that wish to get involved (start) in clinical trials of pharmaceuticals and medical devices;
  • Clinical Research Site development;
  • Easy and fast Site Start Up (IRB-IEC/RA submission, site feasibility process, contracting external facilities to perform study procedures);
  • Support of clinical research sites in Clinical Trial Agreement (CTA) negotiations;
  • Continuous support of site from initiation in the study until site closure;
  • Staffing (hiring of qualified site coordinators, sub-investigators and consultants);
  • Staff training (ICH-GCP, protocol and other clinical research topics);
  • Enrollment (development of recruitment materials, referral management, field recruitment, review and follow up of site enrollment targets, pre-screening);
  • Patient compliance & retention;
  • Support of site in safety management (reporting SAEs, AEs of special interest, SUSAR-CIOMS tracking etc)
  • Identification of protocol deviations and support in Corrective Action Preventive Action (CAPA) development.

* The abovementioned list is non exhaustive, feel free to contact us for any additional request/information you need.

Clinical Trials of medical devices

  • Support of Clients in development of clinical trial related materials (protocol, IB, project management plans, SOPs etc);
  • Clinical Research Site development;
  • Support of Clients in liaising with Regulatory Authorities, Key Opinion Leaders, Investigators;
  • Support of Clients in Feasibility/Start-up, Initiation, Maintenance and Closure phases of clinical trials of medical devices.

* The abovementioned list is non exhaustive, feel free to contact us for any additional request/information you need.

About

Our mission is to help our customers make most advantage of their operations in most attractive geographical area for clinical research!

We use inexpensive optimized local infrastructure and have low administrative expenditures yet providing high quality services. This approach gives our customers significant benefit to plan their expenses and to always stay within a budget!

Our values

Customer satisfaction
Responsibility
Goal-oriented​

We are Carpathian Research Group
Customers are our top priority!
We are responsible for what we do and how we do it!
Every member of our company is goal-oriented and we act as a whole!
We are committed to full transparency in all our operations!

We have successfully passed ISO 9001:2015, 
ISO 45001:2018 and 17100:2015 certifications

Carpathian Research Group LTD (LLC)

UK office:

Ukrainian office:

Russian office:

  • Russian Federation, 199178, Saint Petersburg, Linia 15th VO
  • info@crgroupe.com
  • Director: Aleksandr Kanskii
  • +7 812 309 54 51