The Takeda Translation Model (Label Translation Management System – LTMS) Rebecca Hamilton Takeda Development Centre Europe Ltd.
Pre-LTMS Process • Pre LTMS implementation, Takeda followed a manual process involving the following steps: Takeda Author label text Takeda provides final approved label text to packaging vendor Translation vendor provides regulatory input per country Takeda adapts template per country (if necessary) CRO reviews and approves translation Translation vendor performs translation, back translation and certification Takeda Development Centre Europe Ltd.
Pre-LTMS Process Challenges • Time: – Typically took up to 6 -8 weeks to complete the translation process due to translator and reviewer being unable to reach a quick consensus – Clinical Supplies group were the ‘middle man’ in the communication chain • Cost: – Paying to translate the same phrases multiple times (how many times has the phase ‘For Clinical Trial Use Only’ been translated)? – Paying for a regulatory review per project • Quality: – Critical errors made in dosing instruction translations despite the multiple checks and reviews (before instead of after; morning instead of evening) – Inconsistencies in label text between projects due to difference of opinions of individual reviewers (between CRO and within the same CRO) Takeda Development Centre Europe Ltd.
The Takeda Solution • In November 2013, Takeda’s LTMS system went live • The system is a web based platform encompassing automated workflows, notifications and translation memories to perform Takeda label translation projects. • Additionally, Takeda have consolidated the regulatory requirements for our global country list into 6 different templates. Both strategic partner CROs had input to agree the regulatory requirements • Translation memory performs ‘indirect’ translation where there are local regulatory differences (for example US caution statement into ‘For Clinical Trial Use Only) • System demo: https: //takeda. sdlproducts. com/ws/login Takeda Development Centre Europe Ltd.
Country Selection Checklist Takeda Development Centre Europe Ltd.
Benefits since implementation (1 st Nov 2013) • 318 individual language projects have been through the system • Average completion time per project = 9 days (longest in past month = 20 days, shortest = 2 hours) • Translation project budgets reduced by 90% from the manual process • Clinical Supplies groups in London, Deerfield, Boston and Osaka are all trained and using the system • Initially 20% match files were typical, we now see an average of 70% Takeda Development Centre Europe Ltd.
Next steps • System upgrade (new release) by March 2015 • New reports being designed to allow better KPIs – – Which languages are quickest/ slowest Is one CRO slower than the other in performing reviews % projects right first time (requiring no amendment by the translator) Trending on the percentage translated from translation memory Takeda Development Centre Europe Ltd.
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