?Copyright: ClinsChain (Shanghai) Clinical Services
Co., Ltd. ICP17019712 By 300.cn
ClinsChain (Shanghai) Clinical Services Co., Ltd.
E-mail:services@clinschain.com
Address: 1st Floor, Building 8, No. 700, Shang Feng Road,
Pudong New Area, Shanghai 200120, P.R.China
Contact us:
+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
phase I
post-commerciali-zation
phase II
phase III
pre-clinical
IMP demand planning and preparation
Our expert team can assist clients in IMP demand planning, budgeting and risk management. This includes collection of relevant 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 market and other countries. 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 more prompt response, more flexible solutions and better prices.
Import/export
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, CCIQ, 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, -20 oC, -80 oC, etc. Throughout the cold chain, we validate all related processes, record and monitor temperature, and have 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
Our ERP system and batch record based packaging process enable us to handle various labeling and packaging requirements of both open label and blind trials. We ensure that the specific packaging plans contain sufficient information of quality control and product traceability. Our project management process ensures that all relevant project information having an impact on operation, quality and timing are captured and defined prior to the start of packaging operation.
Temperature controlled storage
We are capable of warehousing products of various storage temperature. The storage area 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 has been in place to protect goods in storage in case of temperature excursion or other disasters.
Distribution/delivery
Our distribution network covers all cities across China and delivery lead time is generally controlled within 48 hours. According to the specific project requirements, our distribution reach can also cover other countries in the Asia pacific area, US, EU, etc. where clinical trials are conducted. Our transportation system and management process ensure that goods are delivered to the appointed receivers, and emergency response procedures are in place to safeguard products in case of deviations such as delay of transport.
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 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.
Equipment lease and management
We provide lease and management service to clients for equipment and instruments used at clinical sites. This includes one-stop equipment lease and management services including purchase, installation, qualification, calibration, management, return, maintenance, etc.
Consultation on IMP management strategy
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.