Fisher Clinical Services
Labeling
Addressing the challenges of consistency in translations and approvals within the clinical trial labeling process
A major global pharmaceutical Sponsor was seeking a new approach to enhance the efficiency of their supply chain process including their label and translation management approaches.
This group had traditionally managed all development of label text, translations and approvals internally, leveraging their in-country affiliates to support all translations. In addition, the team had a proprietary in-house system with a phrase library and was capable of printing single label panels for clinical trials. All booklet labels were developed through the in- house team but manufactured through external vendors. The Sponsor was seeking a way to reduce timelines, raise their quality and gain efficiencies in their processes.
Our solution was to provide them with an integrated approach that allowed them to leverage the efficiencies of our clinical trial label translation management service that would automate and optimize multi-lingual label development. With a commitment to partner with our label group to produce future labels, the Sponsor was able to gain access to our proprietary Alternative Translation and Label Approval System (ATLASsm) which supports the requirements for translation and regulatory services, delivered a paperless approval process and expedited text generation and proof approval.
ATLASsm is a proprietary system designed to facilitate the label translation and approval process, one of the biggest clinical supply chain challenges to meeting timelines. With the growing expansion of clinical programs to a greater number of countries, the timeline challenges have continued to multiply for Sponsors working in multiple regions. ATLASsm provides online ordering of translations and label proofs, the ability to approve online through an electronic signature with reminder triggers to facilitate the process, and ensures globally consistent terminology and phrases, leading to a major reduction in translation error rates.
The system capabilities were supported through Transperfect – an industry vendor specializing in translations for the pharmaceutical industry and regulatory label compliance. This gives the Sponsor the assurance that the system and processes could continue to grow with their needs and the needs of a dynamic industry.
The first step in the project was to update and upgrade the Sponsor’s phrase library. This involved a full review of the current Sponsor phrase library, and combining it with the current Clintrak template phrase library. A team reviewed the output, removed redundancies and ensured any specialized text that had been developed over the past three years was also included. The output was a standardized, validated phrase library that complied with regulatory guidelines and eliminated the redundancy of the phrases that the previous one had. In addition, the team now had access to the Transperfect resources, removing the burden that had been placed on the country affiliates, allowing them to redirect their efforts to other projects and ensuring that the translations were both regulatory compliant and linguistically correct.
With the migration to the ATLASsm system, the Sponsor immediately reduced their turnaround times for label approvals, which had previously ranged from 4 to 6 months, down to 57 days with the goal being 45 days. After an additional process review and metrics analysis, enhancements are being implemented to achieve that goal. The new turnaround times were easily half of the industry standard of 127 days to approve label text for a multi-national clinical trial.
With the migration to the new system complete, the Sponsor was able to redirect their internal teams to other activities supporting the clinical trial supply chain process. One of the Sponsor consultants for the Oncology Clinical Trial Team summed up the new system, “Thank you for a very simple, straightforward system that's easy to access, understand and use. Whoever conceived gets a gold star as the concise format is appreciated!”