?Copyright: ClinsChain (Shanghai) Clinical Services
Co., Ltd. ICP17019712 By 300.cn
ClinsChain (Shanghai) Clinical Services Co., Ltd.
Address: 1st Floor, Building 8, No. 700, Shang Feng Road,
Pudong New Area, Shanghai 200120, P.R.China
+86（0）21-20270568 +86 18201888025
ClinsChain provides one-stop clinical supply services and supports both local and global markets. The services it offers cover clinical supply needs across
IMP demand planning and preparation
Our expert team 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 scheduling, budgeting, risk management to secure IMP supply and control of costs.
Sourcing of comparator and ancillaries
We are capable of sourcing comparator and ancillaries from both local and global markets. We manage effectively the sourcing 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.
We provide complete import/export solutions. We focus on efficiency, cost control and risk management by deliberately 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.
Cold chain management
We offer complete cold chain solutions covering storage, packaging and transport of products requiring different storage temperature. We are capable of handling products of 2-8 oC, <20 oC, 15-25 oC, -25--15 oC, -80 oC, etc. Throughout the cold chain, we validate all related processes, record and monitor temperature, and put in place layers of emergency response mechanisms to provide maximum security to products.
Label and carton design/manufacturing
We can provide various types of packaging materials including labels, cartons, aluminum foils, etc. according to the specific design of the trials. We can also provide designs of the packaging materials for client’s selection and confirmation.
Labeling and packaging
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.
Storage in Controlled Environment
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 temperature 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 destruction report after destruction is executed.
IWRS Management Service
We can arrange experienced personnel to assist the sponsor in the supply chain management in the drug management system (IWRS), including formulation of drug supply plan, uploading of random number of drugs after packaging, manual order, inventory management, optimization of safety inventory of clinical research center and other management work, so as to ensure the smoothness of drug supply and reduce drug waste.
IMP Management and Strategy Consultation
Our expert team can assist clients in demand planning of IP, NON IP and ancillaries from client’s perspective which may include IP planning, comparator development and planning, clinical trial project planning, sourcing strategy for clinical supplies, IVRS/IWRS strategy, labelling strategy, distribution strategy, inventory management strategy, return strategy, etc.