Storage / Distribution
Storage and Distribution
We are capable of warehousing products with different storage temperature and humidity requirements. The storage environment is set up in compliance with GxP and other relevant regulations and validated accordingly. Temperature control equipment have 100% redundancy and are connected to back-up gen set. The temperature and humidity across all storage areas are monitored by the 24x7 temperature and humidity monitoring and alarming system. In addition, multiple levels of emergency response and BCP procedure have been in place to protect goods in storage in case of temperature/humidity excursion or other disasters.
Our distribution network covers all over the world. In China, all major, small and medium-sized cities are covered and can be delivered within 48 hours. In foreign countries, we cover Asia Pacific countries, the United States, European countries and other clinical trial destination countries. Our cold chain solution can ensure the realization of tempera- ture control and recording in the whole transportation process. Our transportation system and management process ensure the first-class delivery service ability, delivery to designated personnel, and formulation of an emergency response process for the risks of possible delays in the distribution process, so as to ensure the safety of goods.
Return and Destruction
We provide the service of collection, receiving and reconciliation of post-trial returns according to the defined clients’ requirements. Returns can then be arranged for destruction through qualified licensed destruction vendors. As needed, we can arrange quality person to participate in the destruction process and provide destruc- tion report after destruction is executed.
Import and Export
We provide complete import/export solutions. We focus on efficiency, cost control and risk management by deliber- ately managing the customs operation which covers customs pre-declaration, HS code classification, check of transportation and declaration documents, application of import license, customs declaration through different ports, CIQ, consultation on import price, operation of bonded and non-bonded goods, temperature control for goods under custom’s surveillance, etc.
Labeling / Packaging
Packaging Material Design and Production
According to the needs of clinical trial drug packaging, we provide design and production services of various languages and types of labels, cartons, packaging bags and other packaging materials. Our experts can provide customized label and packaging material design schemes for customers to choose according to customers' clinical trial design and drug packaging requirements. CLINSCHAIN has its own label printing and automatic inspection system, which can flexibly arrange label production and effectively control the timeliness of label production.
Labeling and Packaging Production
CLINSCHAIN provides various secondary packaging and primary packaging services in a controlled environment. Secondary packaging services include double-blind labeling, patient kit assembly, wallet packaging and other types; Primary packaging services include bottling, blister packaging (aluminum / aluminum, aluminum / plastic), etc. Our ERP system and batch record based packaging process ensure that we can deal with various packaging and labeling requirements of open label and blinded trials. The packaging protocol generated for each project ensures quality control and traceability. Our project management process ensures that all key information that may affect packaging requirements and quality is clearly identified with customers and that strict quality control is carried out during operation.
We are capable of sourcing comparator and ancillaries used for clinical trials from both local and global markets. We manage all processes across purchase, cold chain management, import license application, import/export, storage and inspection, etc. Our supply network and integrated procurement enable us to provide clients with prompt response, flexible solutions and better prices.
Value Added Services
IMP Demand Planning
The expert team of CLINSCHAIN can assist clients in IMP demand planning, budgeting and risk management. This includes collection of relevant clinical trial planning and execution information for demand planning, project sched- uling, budgeting, risk management to secure IMP supply and control of costs.
IRT Management Service
The project management personnel of CLINSCHAIN, as non-blind individuals, can help clients manage the drug management system, assume the role of supply chain manager, monitor and coordinate the drug supply process in all aspects, ensure timely supply of medication in clinical research centers, and avoid unnecessary drug waste.
Experts from CLINSCHAIN can provide regulatory and policy advice related to clinical trials in countries and regions including China, the European Union, and the United States. For the needs of IMP import and export, we can also provide consultation or agency application services for import approvals and other import and export related certificates.
In addition to procurement services, we also provide leasing services for various clinical trial related equipment and medical devices, helping customers directly manage the installation, debugging, maintenance, calibration, recycling, and destruction of equipment during the leasing period