Multilingual global label monitoring for late-stage oncology

A growing US-based oncology company engaged ICON Global Labelling & Ad promo to provide ongoing label monitoring for 25 to 30 authorised medicines used across multiple phase 3 registration studies. ICON was conducting the clinical study and, as part of the clinical regulatory and safety activities, this client required periodic reviews of product information maintained by marketing authorisation holders worldwide to identify updates that could affect information provided to clinical trial participants. 

By combining global labelling expertise, translation capabilities and adaptable document comparison workflows, ICON delivered a reliable monitoring program that identified 100 label changes across 500 labels in four languages from United States, European Union and other international markets. As a result, this oncology sponsor had clarity and confidence around their evolving product information throughout late-stage clinical development.

The client needed reliable capacity to manage a recurring and resource-intensive global label monitoring program. With challenges of volume, access, and formatting, this program required an effective process to avoid delays in identifying and reporting label changes, which could have slowed the client's internal assessment activities.

 
Access to the more than 500 individual labels varied significantly by market, with some documents publicly available and others restricted to healthcare professionals or obtainable only through direct manufacturer requests. Tracking new label versions added further complexity. Regulatory authorities and marketing authorisation holders used different version identifiers, including reference numbers, publication dates and procedure numbers, making it difficult to consistently identify and verify updates across regions.

The labels and documentation also varied in format, ranging from machine-readable files to flat image-based documents which required additional processing before review. This meant that not all comparison technologies would work universally and the available tools would have to be individually assessed and implemented where appropriate.

Additionally, many product labels were only available in local languages. These labels required timely and accurate English back-translations to enable meaningful comparison and review by centralised sponsor teams.

Any delays in providing label monitoring reports and annotated labels would have delayed the sponsor’s internal evaluation of the label changes and subsequent downstream information cascade of relevant information to the clinical trial participants.

ICON provided dedicated global labelling leadership, delivery and project management in combination with efficient workflows and specialised technologies.

Document management

Managing the volume of labels, documents, versions and updates required considerable effort. All identified labels in the public domain were downloaded and stored in a dedicated central document repository to maintain version histories and support reviews. A central master log contained access details (e.g., label sources, website links, and manufacturer contact details) and version-tracking information for each product and country.

Language Solutions

ICON Regulatory Consulting Solutions collaborated closely with ICON Language Solutions to provide accurate English back-translations of updated sections from local-language labels. Back-translations were updated and added to the master log of labels.

Label review

After careful evaluation, ICON selected the most appropriate comparison tools for the different document types and languages, including both purpose-built and commercially available Unicode comparison software, selected on a case-by-case basis according to document characteristics. Expert manual review and assessment was performed by ICON staff to verify and contextualise identified changes.

ICON conducted the periodic label monitoring program for over 40 months, allowing the sponsor to maintain
visibility of important product information updates without investing additional internal resources.

Over the course of the project, ICON monitored and managed more than:

ICON’s scalable global process for monitoring labels across numerous countries and languages delivered consistent reporting despite varied regulatory labelling formats and document sources. Our success resulted in a contract extension with the sponsor, expanding into additional studies.

Connect with us to learn how ICON's global labelling expertise can help streamline complex monitoring activities across markets, languages and regulatory environments