CLINSCHAIN’s operation system is generated based on quality requirements for drug products and the specific requirements related to clinical supply services, coupled with project management needs and client specific needs. It satisfies full spectrum clinical supply needs of local trials, foreign trials and international multi-center trials.
CLINSCHAIN’s operation documentation system consists of around 50 SOPs covering areas across project management, facility management, logistics operation, packaging operation, purchase and ERP operation. Under the SOP system, we have work instructions as necessary to cover project specific operation needs.
CLINSCHAIN’s operation documentation system also defines details for specific clinical supply key processes in order to provide best known solutions while respecting the integrity of the quality system. They include:
△Management of randomization codes
△Facility and equipment management
△Design and production of label and packaging materials
△Distribution order and logistics management
△Return and destruction