Logistics and storage
Smooth Drug Development provides logistics management services in clinical trials.
Logistics is one of the most important elements of the study. Miscalculated delivery schedule or delays in customs clearance may lead to a critical protocol violation of a significant group of study subjects.
Before the study our specialists prepare a Logistics Plan, which includes:
- Obtaining of regulatory approvals for import of investigational product
- Obtaining of regulatory approvals for export of biological samples
- The list of courier companies
- Selection of specialized warehouses across regions
- Selection of vendors for drug and materials destruction
- Purchase of concomitant therapy, equipment and trial materials
- Schedule for drugs and materials supply to warehouses and sites
- Schedule for sending of biological samples to a central laboratory
Transportation and storage are performed in accordance with the manufacturer's instructions, using shipment containers and temperature sensors. Deliveries are performed in a temperature range from -70 °C to +37 °C. Compliance of the temperature conditions during transportation is carefully controlled and documented. Biological samples are picked up by trained couriers from clinical sites.
In accordance with the requirements of standard ISO 9001:2008, our company is very attentive to the selection of its vendors. Before they get approved, they pass a selection process that includes an assessment of the documentation, and for suppliers of special list – quality audit. In the future, we conduct regular and for-cause audits.
When we choose vendors we consider:
- Time on the market
- The level of quality management system
- Experience with leading companies in the industry
- Availability of profile certification
- Facilities and equipment
- Geographical presence
- Previous experience reviews
- Cost of services
Smooth Drug Development – CRO offering a full range of services for conduct of phase I-IV clinical trials in Russia, CIS and Baltic countries since 2011.