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 an sophisticated technology solution which was designed in collaboration with PACT (Project Authoring for Clinical Trials) group.

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PRISYM 360

This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.

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SERVICES

Our team of in-house compliance and validation subject matter experts and professional services and support teams can support you from implementation through beyond delivery.

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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, Increasing Operational Efficiency, Operations & Labeling, Regulatory & Compliance, Whitepaper -

Global clinical trials labeling can be a complex subject and is an integral part of clinical trials supplies management. The landscape is varied in terms of the systems and processes employed in designing, populating and printing labels - including booklets and instructions for use (IFUs).

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