Carpathian Research Group positions itself as clinical research organization focusing in 3 core equal directions of activity:

 

CLINICAL 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

 

SITE MANAGEMENT ORGANIZATION

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.