USING AN
APPROVEDPHRASE
LIBRARY

Introduction

3

Beginning the label process4

Storing local regulatory requirements

5

Other key features

6

Accommodating changes over time

7

Case study: Speeding label approval82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 theworkloads of clinical teams and affiliate staff.
As a global leader in clinical supply chain
management, Fisher Clinical Services is setting thepace for improved translation management withthe use of ATLASSM (Alternative Translation andLabel Approval System). ATLAS—the only system
available to address the full spectrum of label
development, from text translation and approvalthrough label manufacturing. This ebook discusses
the challenges of translating and approving 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

Beginning the label process
START

Establish the order in the online system• size of the study

1Entering the label attributes including:

2Enter or load the contacts to whom the label should be sent into the system.

3

Select the required English phrases from a drop-down menu

• study number• other specific details

For clinical trial use only

4

NOTE: It isn’t necessary to manually select all of the corresponding translations.
The Library automatically populates the phrases in all of the relevant languages,
exporting the label copy in the appropriate languages to be sent to the right contacts.

5In the end, instead of having to translating as many as 500 phrases, it’s likely that fewer than 20 specificphrases will require translation. The process is completely paperless; affiliates can translate, review andapprove electronically—including electronic signatures.

END
4

Storing local regulatory requirements
Local regulatory authorities may mandate inclusion of certain phrases
in a label, one example of which is “for clinical trial use only”. Thesephrases are stored in separate areas of the repository. When a particular
type of label is selected—such as a small vial, for instance—anyadditional country-specific phrases will automatically populate.

Local regulatory authorities may
mandate inclusion of certain phrases...

This feature saves affiliate time and work. It replaces the need to routeall-English text and make country approvers responsible for bothtranslating text and adding country-specific phrases. With an approved
phrase library, it all comes together at once.

Mandated phrase“for clinical trial
use only”

Store in repository

Country specificphrases willautomatically populate5

Other key features
Web-based for convenience
The library is located on a secure website,requiring only internet access to gain access.
Users can pull phrases from the library,review and approve label copy from anywherein the world.

Automatic reminders
Scheduled email triggers remind
affiliates about deadlines for translation
and approval.

Revisions with change control
The library captures revisions and phrase
updates, while blocking unapproved phrases.
In addition to capturing legitimate updates,
the system notes the identity and locationof the individual who requested the change.
This provides version control that is missing
when individuals maintain spreadsheets ofcommonly-used phrases on their desktops.

24/7 Access from anywhere
Users can log in virtually anywhere atany time—in the office, at home or while
traveling—providing maximum flexibility.

Most current phrases only
The system ensures that only the current
phrases are being used, versus other system

Limited accesswith single administrator
The system permits the administrator to provide
users with access only to the areas they needto see—e.g., if responsible for pulling phrases,
access to do only that; if an approver, accessonly for approvals. In addition, the administrator
can determine who is authorized to makechanges, ensuring the integrity of the library.

6Accommodating changes over time
MISCONCEPTION:

TRUTH:

TRUTH:

Phrases used in an
approved phrase librarychange over time.

Phrases do not change over time,
although preferences for phrases
may. While one phrase may be
preferred over another, personal
preference does not render adifferent translation of the samephrase incorrect. Clients cancustomize the library to reflectchanging phrase preferences.

Regulatory requirements, on theother hand, can and do change.
In addition to storing standard
phrases, the library is a repository
for viewing the latest regulatory
templates and requirements,
which can be updated as often
as necessary.

7

Case study: Speeding label approval
DAYS FOR TRANSLATION AND APPROVALBEFORE
ATLAS

52+50%
Reduction

DAYS

AFTER
ATLAS

19DAYSA leading pharmaceutical company
selected as a pilot a large Phase III
clinical trial with clinical sites in 18
countries. Its translation and approval
process had been taking about 52 days:

The use of an Approved Phrase
Library reduced the timeline by morethan 50%—from 52 days to 19 days:•

Supply core text—1 day••Supply core text—1 day•

Compile translations—3 days•

Create proofs—1 day

Compile translations—5 days•

Route proofs—1 day•

Route documents—2 days•

Affiliates approve proofs—8 days•

Affiliates approve text—20 days•

Client quality proof review—5 days•

Create proofs—5 days•

Proofs final review—2 days•

Final proof review—15 days•

Final quality review—2 days

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.

8

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