LABEL MANAGEMENT SOFTWARE
Label generation using variable data at time of print
Language and phrase support
Label content regulatory rules and more...
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.
Overcoming the Top 5 Challenges for On Demand Labeling
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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.
CLINICAL TRIALS LABELING RESOURCES
Discover how PRISYM ID helped Biotec Services International Limited...
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).