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+ 375 17 283 17 38

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Contract research services to medical companies Belnico

BELNICO CRO – Your Guide in the Field of Clinical Trials!

Thank you for visiting our Contract Research Services!

We are happy to take this opportunity to present our contract research services as a contract research organization. In all our services we rely on professionalism, international standards (ICH GCP, SOP, PMBOK, other) and ethics. Our cornerstones are professional project management, communication, education, and loyalty.

Clinical Logistics Management

Clinical Logistics Management» IMP Import/Export, IMP Distribution, IMP Storage, All Required MOH and LEC Approvals, Liason with the MOH and sites, sites selection, sites activation

Monitoring» eCRF, paper CRF, monitoring visits to sites, monitoring reports, participation in TCs, all other monitoring activities

Filing Management» ISF, TMF, other required filing

Financial Management» Financial Conduit with Sites and other Local Organizations

Project Management» PMBOK, CRA Hire, Approvals, Insurance, QA, Other Control

HR Management» ICH GCP staff, Network, Communication

Import/Export of Clinical Supplies

  • Cooperation with reliable couriers with proven names and reputation to import/export medications to/from Belarus
  • Collaboration with professional customs brokers to timely and expeditiously process clinical supplies through customs clearance procedures
  • Assistance with acquiring required equipment, materials and/or ancillary supplies for clinical trials in Belarus
  • Shipment of samples to the central/local laboratories

Distribution of Clinical Supplies

  • Distribution of supplies, patient forms, and kits to clinical sites according to the required SOPs
  • Compliance with all procedures and requirements pertaining to such distribution
  • Speed-load, preparation, and transportation escort of clinical trial supplies by a responsible specialist in specifically-designed thermal containers or coolers
  • Distribution of ancillary equipment, investigator literature to clinical sites

Storage of Clinical Supplies

  • Professional, licensed warehouse for storage that meets all GCP standards with restricted access, quarantine chamber, controlled temperature and humidity, modern professional refrigerators with multiple temperature modes, and a log system
  • Receipt and storage of tests and blood samples at controlled temperatures, e.g. at freezing, cooling, or other required temperatures
  • Temperature tracking logs according to required standards
  • Return, collection, and control over accompanying documents and clinical trial supplies
  • Destruction of utilized and non-utilized supplies
  • Inventory management
  • Other logistics support

Monitoring

  • Professional monitoring eCRF data in eCRF per eCRF guidelines or through paper eCRF
  • Monitoring visits to sites during active and non-active phases
  • Monitoring reports and monitoring correspondence
  • Participation in teleconferences with Sponsor or global CRO
  • Serve as a main point of contact between Sponsor and sites
  • All other monitoring activities

Filing Management

  • Assistance with ISF
  • Assistance with TMF
  • All other filing assistance

Financial Management

  • Control over managing all designated funding for a clinical trial or its phases
  • Contract administration including contracts with clinical sites, couriers, brokers, and other parties
  • Official payments to Belarusian city authorities
  • Payments to clinical sites, couriers, brokers, and other involved parties
  • Procurement services for additional equipment, devices for clinical trials
  • Other financial provisions

Project Management

  • Professional project management consulting and implementation
  • Compliance with PMBOK standards from initiating, planning, carrying out, controlling to fulfilling individual or group processes in contract research activities
  • Selection of required, skilled, experienced investigators
  • Obtaining MOH and LEC approvals, permissions, certificates, and other documents to support a clinical trial during all its phases
  • Negotiating agreements with clinical sites, investigators, and other stakeholders
  • Monitoring all current and new legislative acts, edicts, and other official documents pertaining to clinical trials in Belarus
  • Arranging a local insurance for conducting clinical trials in Belarus
  • Quality Assessment support/compliance including Sponsor Audits and visits
  • Full support and arrangement of Sponsor-Investigator meetings, discussions
  • Medical translation
  • Other Project Management support

Human Resources Management

  • Experience staff with over 15 years
  • Excellent reputation of conducting clinical trials in Belarus for over a decade
  • Close, professional ties with local authorities
  • Ever growing network and contract agreements with experienced investigators and sites
  • High level of intercultural communication
  • Professional, ICH GCP trained clinical trials personnel

 

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