ClinsChain provides one stop clinical supply services and supports clinical operation in both local and global markets. It satisfies clinical supply needs across pre-clinical, phase I, phase II, phase III and post-commercialization. The services it provides include
IMP demand planning and preparation
The expert team in ClinsChain are able to assist clients in IMP demand planning, budgeting and risk management. This includes collection of relevant information for demand planning, project scheduling, budgeting, risk management, etc. for the purpose of securing IMP supply and control of costs.
Comparator sourcing
Through synergizing with its the extensive network of strategic partners and suppliers, ClinsChain is able to source comparator from both local market and other countries, and effectively manages the sourcing processes of purchase, cold chain management, import license application, import/export, storage and inspection, etc.
Import/export
ClinsChain provides complete import/export solutions. It focuses on efficiency, cost control and risk management through the processes which usually include 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
ClinsChain has a complete cold chain solution and implemented comprehensive processes of validation, operation and quality control to protect goods from temperature excursion and add security across the supply chain of storage, packaging and transport of products of various storage temperature. It is capable of handling products of 2-8 °C， <20°C, 15-25°C, -20°C，-80°C , etc.
label and carton design/manufacturing
ClinsChain designs and provides various types of packaging materials including labels, cartons, aluminum bags, etc. Clients can either provides their design to ClinsChain for manufacturing and quality control or they can delegate the whole design and manufacturing to ClinsChain.
Packaging
The ERP system and the batch record based packaging and quality control process ensures that ClinsChain can satisfy the labeling and packaging needs of both open trials and blind trials. The packaging plan developed in ClinsChian ensures the placement of all necessary quality controls throughout the packaging operation to avoid product mixing and ensure traceability pre and post packaging. The project management process ensures that all relevant project information that have an impact on packaging needs and quality are clarified and defined with client prior the start of packaging operation. It can ensures that the execution of the packaging operation will be well managed both from the timing and quality perspectives.
Storage of various temperature
ClinsChain is capable of storing goods of 2-8 °C， <20°C, 15-25°C, -20°C，-80°C, etc. The storage area is set up in compliance with the quality requirements of GMP, GSP, GCP as well as other relevant regulations related to clinical supplies, and validated accordingly. Temperature control equipment have 100% redundancy and are connected to back up gen set. The temperature and humidity across all storage area is connected to 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
ClinsChain’s distribution network covers all cities across China and delivery lead time can be generally controlled within 48 hours. According to the specific project requirements, ClinsChain’s distribution reach can also cover other countries in the Asia pacific area, US, EU, etc. where clinical trials are conducted. The transportation system and the management process defined in ClinsChain secures that clinical supplies are delivered to the appointed persons at clinical site, and at the same time defines the appropriate response procedures in case of deviation situations such as transportation interruption.
Return and destruction
ClinsChain supports 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, ClinsChain can arrange quality person to participate in the destruction process and provide destruction report after destruction is executed.
Equipment lease and management
ClinsChain provides 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
The expert team in ClinsChain 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. For multi-national trials, ClinsChain can assist in IOR service, import duty/VAT, import/export process, labeling requirements, ancillary supplies, expiry date extension, return and destruction, sampling, as well as other specific requirements.