Clinical Trials

CLINICAL TRIALS LABELING

The increase in clinical trials complexity, coupled with the significant rise in trial drug costs, is driving an industry-wide need for more flexible and cost-effective clinical supply operations.

For many clinical research organizations, the goal is to build a supply chain operation that can achieve fast trial start-up, and support unexpected amendments to trial protocol – such as changes in clinical sites, countries and expiry dates - without unacceptable levels of stock ‘overage’, or the risk of not complying with local regulations.

The supply chain model emerging as industry best practice is for the ‘on demand’ packing and shipping of clinical trial packs to patient sites in response to confirmed patient demand. This strategy also enables the consolidation of distribution depots and the option to adopt drug stock pooling.

In designing an effective on demand supply chain, it is the clinical trial labeling that can present the most challenges; for these, we provide  PRISYM 360,  which was designed in collaboration with PACT (Project Authoring for Clinical Trials) group.

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PRISYM 360 CLINICAL TRIALS DEPLOYMENT OPTIONS

Clinical Trials SaaS
Clinical Trials
  • Cloud based compliance ready end-to-end label management and control
  • Specialized clinical trials printing processes
  • Clinical Trial data schema
  • Clinical Trial labels print summary reports
  • E-labeling output
  • Professional Services offerings to support rapid deployment

Designed for clinical trials supply chain requiring controls around printing trial labels and booklets.

On Premise
Clinical Trials
  • Full functionality of PRISYM 360
  • Ability to control your labels end to end
  • Integrations with ERP,PLM,MES systems
  • Vision inspection
  • Clinical Trials full suite
  • Blue Prints
  • Professional Services

Designed in partnership with our customers, it is truly the benchmark for validated labeling applications in Life Science.

Private Cloud
Clinical Trials
All the features of On Premise +
  • Dedicated Private Cloud environment
  • Cloud provider specializing 100% in Life Sciences
  • Strict compliance with GxP practices
  • SSAE 16 SOC Type II and ISO 27001 / 14001 certified Security processes
  • Offsite data backup and Disaster Recovery
  • Full managed service options

Addresses the need for organizations that do not want to be responsible for managing the infrastructure or on-going maintenance.

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CLINICAL TRIALS LABELING RESOURCES

Mind Your Language whitepaper 1 - Mind Your Language! Requirements for Local Language Labeling in Clinical Trials Mind Your Language! Requirements for Local Language Labeling in Clinical Trials Posted in: Achieving Regulatory Compliance, Clinical Trials, Operations & Labeling, Regulatory & Compliance, Whitepaper -

Global clinical trials labeling can be a complex subject and is an integral part of clinical trials supplies management.

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