Storage / Distribution
Storage and Distribution
We provide storage environment with controllable temperature and humidity (15-25℃, 2-8℃, <20℃, 20-30℃, -25--15℃, -80℃, -190℃, etc.). The storage environment complies with the GxP quality standards and has passed strict validation. The temperature control unit is designed with 100% capacity redundancy and backup generator. The temperature and humidity monitoring system monitors temperature and humidity 24x7. An emergency response system is in place in the event of temperature and humidity alarms to safeguard goods in storage.
Our distribution network has global coverage. We cover all major, medium, and small cities in China, and the vast majority of cities can be delivered within 48 hours. Internationally, we cover all clinical trial destination countries and areas in Asia Pacific, the United States, and Europe, etc. Our cold chain solution ensures temperature control and monitoring throughout the transportation process. Our transportation system and management processes ensure first-class delivery service, while having an emergency response procedures in place for containing risks during delivery.
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 a qualified person to oversee the destruction process and provide a destruction report after the destruction is executed.
Import and Export
We provide complete import/export solutions, optimization of the I&E efficiency, cost control and risk management by deliberately managing the customs operation which covers customs goods pre-classification(HS code), check of transportation and declaration documents, application of I&E 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 primary packaging and secondary packaging services in a controlled environment.Primary packaging services include bottling, blister packaging (aluminum / aluminum, aluminum / plastic); Secondary packaging services include double-blind labeling, patient kit assembly, wallet packaging, 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.
Procurement Service
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 responses, flexible solutions and competitive prices.
We provide flexible sourcing models, such as agency procurement, procurement & supply, procurement & leasing, etc. The product categories covered include comparators and placebos, medical auxiliary equipment, clinical consumables, ward care products, disinfection supply center products, health management products, general outpatient products, etc.
Value Added Services
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IRT System Service
CLINSCHAIN's IRT system can provide complete and
compliant randomization and drug management services. This
system can providecustomized system solutions for Phase I
dose ramp up trials, Phase II and III multi group and unequal
proportion group trials, and can providefunctions such as
intelligent drug application, comprehensive system
notification, data statistics, and logistics docking.The
project management personnel of CLINSCHAIN, as non-blind
individuals, can help clients manage the IRT system, assume
the role ofsupply chain manager, monitor and coordinate the
drug supply process in all aspects, ensure timely supply of
medication in clinical researchcenters, and avoid unnecessary
drug waste.
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Regulatory Consultancy
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.
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Equipment Leasing
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
Clinical Supply Management Service
The CSM expert team of CLINSCHAIN helps clients optimize clinical supply management of CTP intepretation, supply strategy, packaging plan, logistics and import and export strategy, expiration date management, procurement strategy, supply plan and simulation, etc. across various stages of clinical trials, including strategy development, study initiation, patient recruitment and medication maintenance, and study closure.
Our expertise and extensive resources can help clients achieve the following goals in their clinical supply strategy:
· To meet the requirements of clinical research protocols
· To reduce the risk of research delays or subject dropouts due to drug supply reasons
· To meet compliance requirements
· To save overall costs and improve efficiency
· To minimize drug waste to the greatest extent possible
· To maximize the value embodiment of the sponsor
Ultra-low Temperature Service(for CGT)
CLINSCHAIN's ultra-low temperature supply service is established in accordance with industry high quality standards, providing an overall solution as low as -190°C, ensuring professional operation and temperature control throughout the entire chain of goods receiving, storage, labeling, distribution, and transportation, fully supporting the needs of CGT products.
CLINSCHAIN's leading solutions provide maximum assurance for product safety and compliant operation. The ultra-low temperature storage facility is equipped with advanced equipment and functions such as automatic detection and replenishment of liquid nitrogen level, dual safety valve structure, automatic rotation and extraction of goods, barcode management, automatic temperature recording and alarm, on-site oxygen automatic detection and fresh air system, backup generator, etc. The transportation of ultra-low temperature goods adopts a strictly validated liquid nitrogen packaging scheme, which tracks and records temperature throughout the process, and with multiple risk management measures and a backup mechanism for transportation related records.
As an important component of a one-stop ultra-low temperature supply service, CLINSCHAIN's rich import and export experience in various biological agents, cells, and blood samples can provide customers with the best solution for cross-border operations, manage related risks in advance,and better control the import and export process.
