REASONSFOR BUILDINGAN APPROVEDPHRASE
LIBRARY

Introduction

3

Risks of not building a phrase library4

Benefits of building an approved phrase library

5

Case study: Speeding label approval72

Introduction
The challenge of creating labels forinvestigational drugs is mounting
as more countries sign on toparticipate in clinical trials. Delays
in translating and approving clinicallabels—a process that averages
about 120 business days—canprevent clinical trials from startingon time and threaten to derail
development timelines.

The issue boils down to one of process andpriorities. Affiliates responsible for translating
and approving labels often postpone the timeconsuming process to address other pressing
matters, causing delays. Since translations are
performed manually, inconsistencies and errors
frequently result, the potential consequences ofwhich can be more serious than merely having tocorrect or reprint the label.
A proven solution to the problem of label creationis the use of an approved phrase library, anelectronic repository of globally consistent, multilanguage terminology that virtually eliminates
the need for manual translation. With a single
mouse click, the library automatically translates
label text into multiple languages. Implementation

Label issues are cited by regulators
as a major reason for rejecting
New Drug Applications (NDA)of an approved phrase library has been shown
to shorten label cycle times by more than 50%,
improving clarity and consistency and reducing
the workloads of clinical teams and affiliate staff.
As a global leader in clinical supply chain
management, our Clinical Label Services teamis setting the pace for improved translation
management with the use of ATLASSM (AlternativeTranslation and Label Approval System). ATLAS—
the only system available to address the fullspectrum of label development, from text translation
and approval through label manufacturing. Thisebook discusses the challenges of translating andapproving label text, and how an approved phrase
library can reduce label timelines, improve quality,and assure regulatory compliance.

Our Clinical Label Services teamis setting the pace for improved labeltranslation management with the use ofATLAS

SM3

Risks of not building a phrase library
The average timeline of 120 business days to generate
approved text for a clinical label involves the collective
effort of hundreds of individuals across the globe.

Without approved phase library
Translation
begins inEnglish

The responsibility for translating and approving labels falls on company
affiliates, usually subsidiaries or Contract Research Organizations (CRO).
The process begins with the drafting of label text in English by a project
manager, who routes the template to affiliates.
Affiliates must manually translate the text into their local languages, review
it to ensure that it meets local regulatory requirements, and approve it—allbefore the study can commence. For some large multi-national trials, label
text may require translation into dozens of languages. In addition to the timecommitment of translating a label, there are often as many as 10 individuals
in a single country who must approve it.
Affiliates have heavy workloads. They often relegate label translation
to a back burner while they address a host of other priorities, such as
manufacturing, distribution and especially patient recruitment. The result:delays, missed deadlines and the possibility that a trial might not begin ontime, potentially derailing the development timeline.

Subsidiaries or CRO(Contract Research Organizations)

AFFILIATES TRANSLATE INTO THEIR LOCAL LANGUAGE

Mandarin

GermanHindi

FrenchSpanish

ItalianResults
DelaysMissed deadlines
Derailed timelines4Benefits of building an approved phrase library
The use of an approved phrase library simplifies the process of label translation and approval—improving clarity
and consistency, easing workloads and, importantly, reducing cycle times.
Greater clarity and consistency

Less interpretation

There are as many ways to translate the same phrase
as there are translators, each of whom has a personalpreference. Consider, for example, the phrase “Takeone capsule one time per day,” which can also beexpressed as “Take one capsule daily,” “Take onecapsule once a day,” and even “Take one capsuleat any time during the day.” While all are technicallycorrect, the inclusion of different translations of thesame instructions in the label is inconsistent.

In some affiliates, individuals responsible fortranslating label text may create and share a listor spreadsheet of translations for commonly usedphrases. The translations may be stored on adesktop or shared drive. Over time, new phrases
are added and others revised, reflecting individualinterpretations and preferences, and potentiallyresulting in many different versions of the samephrases. The use of an approved phrase libraryeliminates the need for local lists/spreadsheets,
as well as subjective interpretation.

Clear, consistent language ensures that all patientsin a clinical trial receive identical instructions. Repeat
use of the same phrase provides the clarity andconsistency that are valued by regulatory agencies.
In creating an approved phrase library, standardtranslations are developed for each commonly usedphrase in every language. These approved phrases
then automatically populate whenever a label iscreated and routed to affiliates for translation andapproval. Clients have the option of building their own
custom repository of standard phrases or accessing
the body of standard phrases provided in ATLAS.

Standardization and predictability
By building a library of approved phrases,
each affiliate approver is assured of signing off
on identical language.

Decreased risk of errors
When translations are performed manually, humanerror can occur. It is during the process of retyping
and editing that variations are likely to creep into
text, and a misspelled, transposed or dropped
word can drastically alter the meaning of a word orphrase in some languages.
Project managers cannot be expected tounderstand every language and may not recognize
translation errors. As a result, labels containing
errors could be printed and distributed, a problem
that can cost thousands of dollars to correct. The
use of an approved phrase library ensures theaccuracy of phrases and minimizes the need fortranslating, retyping or editing.

Clarity and consistency are valued by regulatory agencies

Eliminate errors,
individual interpretations
and preferences
瓶 – bottle

小瓶 – vialarn.
räckhåll för bm
tousraa
Förv
Keep out of reach of children.

khåll för barn

Förvaras räc
Keep in reachof children

For clinical tr

Limit to bed

ial use onlyexperiment use5

Benefits of building an approved phrase library

Flexible revisions

Reduced workloads

Curtailed costs

Shorter cycle times

Should the study protocol
be revised, as is frequently
the case, an approved
phrase library provides
the flexibility of revising
only those portions of thelabel that require change.
The entire label does nothave to be translated andapproved again.

Translating label text is often
considered to be the least
critical part of affiliates’
jobs. Experience showsthat an approved phrase
library can halve the time ittakes affiliates to translate,review and approve. Thisturns a labor-intensive,
time-consuming task into
speedy review and approval.
By reducing translation
and approval time, affiliates
can concentrate on otherpressing matters.

Translating a label often
requires the services ofa translation company,a cost that is passed on,
especially when using
CROs. Once a standard
phrase library is establishedand in use the need tohire translation companies
diminishes sharply.

An approved phrase
library means that muchof the work of translatingis already done when alabel reaches affiliates,
shortening the cycle timesignificantly. Instead oftranslating 20 phrases,affiliates may have totranslate only one or two
new phrases. These newphrases can then bestandardized and added to
the library for future use.

REDUCE TIME & COST

Approved phrase library can reduce the time and save costto translate, review and approve label.

6Case study: Speeding label approval

ATLAS

SM

ATLAS and its approved phrase
library is making it possible tosignificantly reduce the labeltranslation and approval timeline—
in some cases by more than half—
as it has for two pharmaceuticalclients. While it took time toestablish a customized global
process for these clients, they
are reaping the benefits of theprocess while being able to use
the metrics for continuous process
improvement.

A large pharmaceutical client was averaging 127 days to finalize label text.
The company implemented full ATLAS service, including online ordering, regulatory
content, management of approvals and, of course, an approved phrase library.
It took about three months to finalize the process, build the custom library, develop
documentation and provide training in advance of the date the system went live.
The effort was well invested: In the initial experience, finalizing label text took
57 days, an immediate savings of 60 days, from the start date.
DAYS TO FINALIZE LABEL TEXTAVERAGE

127
DAYS
127
AVERAGE

BEFORE
ATLAS

AFTER
ATLAS

DAYS

57

DAYS

7

ATLASSMThe industry’s first clinical, web-based, label-specific translation and approval management system,
ATLAS, that comprehensively addresses the full spectrum of label development, streamlining
the process from text translation and approval through label manufacturing.
LEARN MORE

8+1 919 226 3200 • thermofisher.com/patheon • pharmaservices@thermofisher.com© 2021 Thermo Fisher Scientific Inc. All rights reserved.
Published 09/21