Drug Storage and Distribution
Pharm-Olam offers a local Clinical Supplies Unit (CSU) in Russia with experienced and dedicated staff to run the unit as well as logistics staff to aid in import/export operations and drug distribution. Services provided include labeling, customs clearance organization, proforma-invoice and shipment documents review and agreement with the customs brokers, shipment control, storage (IMP, lab kits, equipment and other supplies), distribution of supplies, and return and/or destruction of supplies. Full logistics and storage support can be provided to our clients from the moment the study is planned until the moment it is finished. Pharm-Olam has developed a strong relationship with local vendors for IMP and supplies cooperation:
- Licensed international and local customs brokers for export/import operations
- International and local couriers for distribution from customs to depots and depots to sites and both vice versa
- Licensed destruction companies, offering different methods of medical wastes disposal, followed by destruction certificates provision
Our logistics and CSU specialists work out logistic schemes for each project, taking into account its peculiarities, and always provide recommendations regarding which brokers and couriers should be better used for given investigational products and supplies. Pharm-Olam drug storage and distribution works in accordance with applicable GMP and GDP practices and local requirements, with SOPs in place written in English.
Should you require drug storage and distribution services, contact us to learn more about our capabilities.
Our Russian CSU is situated in Pharm-Olam’s Moscow office. The CSU premises are located on the 1st floor of the same building where the clinical staff is located. This allows fast internal agreement and confirmation of IMP and supplies shipments and fast reaction in case of an urgent situation. The Russian CSU is equipped with:
- Storage of IMP and other CT materials at room temperature +15+25°C
- Storage at +2+8°C & subzero temperatures (to -90°C)
- Humidity and temperature monitoring (including automatic SMS notifications to staff in case the indications are close to limits)
- Power outage alarm and power generator (in case of power outage)
- Storage agreements with outside companies (in case of long-term power outage)
- Security system and program support
Our storage units have been audited by several sponsors with successful outcomes. During these audits the auditors especially indicated that the facility and quality systems were found to be well developed and in a state of control; all members of staff were friendly and professional, answers to the questions and related documentation were provided without delays.