Clinical Trials

The Challenges in Clinical trials Labeling

Clinical trial supply labeling, performed either in-house or through CROs/CSO, is one of the most challenging labeling operations.

The complexity of Investigational Medicinal Product (IMP) and study protocol data, the extensive regulatory and language labeling requirements, and the breadth of countries often included in a study, create a content control challenge that ERP systems are unable to meet.

Delays in label and booklet design, approval and production can impact study start-up or clinical pack supplies, whilst errors may adversely affect study results or even patient safety. The criticality of error-free labels is reflected in the FDA’s regulation for 100% visual inspection of IMP labeling.


PRISYM 360 delivers innovative content management features which incorporate industry best practice, designed specifically to meet the highly complex regulatory requirements essential for clinical supplies labeling.

Master Label Text /Country Label Text (MLT/CLT) functionality, Regulatory Rules and Phrase and Language management features ensure labels and booklets can be designed quickly and accurately, whilst industry specific workflows streamline the review and approval process vital to assuring optimal delivery.

Where labels and booklets are printed in-house, clinical supplies labeling-specific print processes deliver industry best practice for flexible production models such as batch and Just-in-Time, whilst PRISYM 360’s leading Vision print inspection provides quality assurance by capturing and reporting content print errors in real-time.

PRISYM ID’s unique clinical trial labeling content features and best practice provides certainty that clinical labels and booklets are produced accurately, efficiently, and compliantly, to support today’s complex, adaptive clinical studies.

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Booklet - Clinical Trials

Clinical labeling teams often utilize English MLT/CLT variants to define the content for clinical trial labels and booklets.

As the number of countries included in each study increases, with each having specific regulatory content, phrase and language requirements, so the manual process of designing and printing booklets takes more time and effort, leading to greater risk of error.

PRISYM 360’s MLT/CLT solution prompts users for study information, and then automates the generation of MLT, CLT and booklet design based on its knowledge of content and design requirements. This reduces clinical label and booklet creation from weeks to hours, ensures regulatory requirements are met and reduces risk of errors.



Print Inspection - Clinical Trials

Clinical labeling regulations require 100% labels are inspected for errors, but manual visual inspection of printed labels is laborious, costly and error prone. Print inspection technology should help, but is difficult to set-up, and creates an operational overhead of running two systems, labeling and print inspection.

By knowing the label’s design and content, PRISYM 360’s fully integrated Vision print inspection simplifies and automates real-time inspection on both the content and design of every printed label. This minimizes effort in inspection setup and operation, and identifies more errors at time of print.



JIT Print - Clinical Trials

With the increase in biologics studies, the cost of clinical trial stock overage and the risk of clinical packs incorrectly labelled with out of date expiration and dosage information is significant.

Clinical supplies is challenged to shift from traditional production and supply models such as batch production to a more flexible on-demand or Just-in-Time model.

PRISYM 360’s Print Processes perform dynamic label generation, using label templates and logic to retrieve the latest approved content in real time to enable just-in-time printing and packing production models. This ensures the latest, approved expiration and dosages information is used, as well as enabling new supply models such as direct-to-patient.


Regulatory Changes

EU Clinical Trials Regulation No 536/2014

Many Clinical Supplies teams consider that Annex VI of the EU Clinical Trial Regulations introduces new labeling challenges.

In particular, Annex VI D (replacing of information) indicates any changes to period of use (expiry/retest) requires a change on the immediate (primary) pack label as well as outer (secondary) pack, performed within a GMP environment. As a result, it may be no longer acceptable to perform expiry date extensions on labels on the outer packaging only and rely on an IRT/RTSM system being the source of the latest date for inner, primary packs.

This new regulation therefore requires changes to process for many in the industry; following our research, we found several different approaches being taken by US and European clinical trial companies to comply.

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