Our business principle and motto are that the CRO and members of the study team relieve themselves of administrative and logistical tasks as much as possible by entrusting them to us so that they can devote themselves to the research process, and that the course of the study proceeds smoothly.

When organizing and providing services, we are fully adapted to all the specific requirements of partners, taking into account that all actions and activities are carried out in order to fully ensure the quality of the entire distribution chain of the IMP, comparators or supportive therapy, medical devices, equipment, ancillaries and other materials from the manufacturer to the sites.

This process is very challenging due to the specific requirements of local legislation during the process of obtaining import/export licenses, customs clearance and importation. Through significant experience in this type of service and cooperation with many recognized world manufacturers, sponsors, local and international experts, we have gained extensive knowledge, experience and contacts, which gives us the opportunity to quickly achieve high-quality and simple fulfillment of our partners’ requirements. Through constant improvements, we have successfully performed a large number of audits of domestic and foreign companies, where we were ranked as the company with very high ratings through the aspects of meeting quality requirements, defined key performance indicators, legal regulations, good practice guidelines and implemented standards.

As reliable collaborators, we responsibly enable all investigated products and other materials within the clinical study to be delivered quickly, efficiently and safely to each site in accordance with the required transport conditions.

Our main goal is to provide our partners with the most efficient logistics support and optimal supply chain management.

Support Services

Support clinical trials includes obtaining import and export licenses for the purposes of clinical studies, import, export, procurement, storage and distribution of medicines and medical devices in clinical studies, as well as organizing the destruction of medical waste through subcontractors.

  • Regulatory services
  • Ensuring the import of drugs for clinical trials, IMP, medical devices, laboratory equipment, equipment and other necessary products
  • Obtaining export licenses for biological samples
  • Customs clearance and import and export services of all products in accordance with the needs of the clinical study
  • Local procurement and distribution of complementary and comparative medicines and other products in accordance with the client’s request
  • Complete documentation management, archiving and reporting

Consulting Services

Consulting services include project development, acquisition, processing and presentation of information obtained from public and private institutions, brokerage.

  • Logistics
  • Local regulations on drugs and medical devices,
  • Local regulations on waste management
  • Other local regulations that may affect the flow of CT
  • Alignment of CRO’s and Sponsor’s SOPs with local regulations and regulations and guidelines – GMP Annex 13, GCP, GDP and GDP (suggestions, amendments, risk management, recovery plan)
  •  Foreign trade business
  • Preparation of documentation for import and export
  • Obtaining various types of import and export permits
  • Complete information about the project through exhaustive cross reports
  • Organizing VC and TC with professional associates and service providers

 

Distribution services

Our fleet currently has six vehicles, five TCVs for conditions 2 °C to 8 °C and 15 °C – 25 °C and one for ambient condition with a portable refrigerator.

  • Daily distribution of shipments to sites in proper vehicles and temperature-controlled transport conditions (ambient conditions/ controlled conditions/ cold chain mode)
  • Providing signed supporting documentation when delivering or picking up shipments from the site – delivery note/receipt note
  • Collection of drugs/medical devices and other products from sites at the client’s request
  • Return of drugs from sites and coordination of permanent disposal of pharmaceutical waste, providing complete traceability documentation and final certificate of destruction

 

Storage services

We have a warehouse secured by video surveillance, alarm, fire protection, insect and rodent control, window security and armored doors, with limited access to unauthorized persons. The warehouse has been validated and meets all requirements according to the law and guidelines of GDP and GSP. Temperature monitoring is automatic with feedback in case of deviations, and temperature records are available over a year back. We also have two cold chambers for storing thermolabile goods, as well as a safe for storing psychoactive substances. All measuring and logistic operational equipment that we have is standardized and validated, and is regularly calibrated and checked according to the assurances of an accredited laboratory.

  • Receiving shipments (qualitative/quantitative control)
  • Product storage in cold chains (from 2 °C to 8 °C)
  • Product storage in ambient conditions (from 15 °C to 25 °C)
  • Quarantine business
  • Services of separation, packaging and preparation of shipments to the site upon request
  • Inventory management, list of product status by studies
  • Receiving returns from locations – qualitative and quantitative control and keeping records of returned drugs, equipment and other materials from sites
  • Labeling services for drugs, medical devices and other products (if requested)