ClinsChain’s operation system is generated based on GMP 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, multi-national trials and international multi-center trials.
ClinsChain’s operation documentation system consists of nearly 60 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.
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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 GMP system. They include:
l Project management l Blinding management l Packaging scheme l Label and carton design and manufacturing l Batch record l Sampling and sample management l Cold chain management and business solutions l Sample storage and management l Serial number management l Import/export l Transportation management l Return and destruction
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lEtc. |
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