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SDL Multilingual Labeling SolutionUnifying the Customer Experience

Presented by: Tom O’Dwyer & Chip Gettinger

May 8, 2014

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Global Labeling Solution

SDL Global Translation Management

CommercializationManufacturing

Pharmacovigilance

RegulatoryApproval

ClinicalPreclinicalDiscovery

Local Language Local LanguageLocal Language

MedInfo (Off-label), SOPs,

Case NarrativesInt. Dossiers,

Training & Sales &Web Content,

Guidance Documents…

ProtocolsInvestigator Brochures

Informed ConsentClinical Report Forms

Questionnaires,Clinical

Summaries…

Labeling Documents: Patient

Leaflet, Summary of Product Characteristics,

Labels, (QRD Templates),PI inside the CTD

….

English Only English Only

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An example: Multilingual Regulatory Necessity per Region

Electronic Labeling Submission and Multilingual Content per Region*

US99:1

JP, Brazil,..50:50

Europe

4:96

*Submissions valid only for one region

Ratio of English to Non-English

RegulatoryApproval

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CP Timelines

Day 0

Day 120

Day 121

Day 150

Day 210 Day 215

Day 276

Clock Stop

Create English

Submission, Negotiation, Approval of the English Baseline (Review Cycle with Rapporteur and CHMP members)

Official TranslationPhase

Linguistic Review

Pre-opinion internal

translation review

Re-view of HAComments

Negotiation with MS

Creation of translation ahead of Opinion

PostOpinion internal translation review

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Phase IDay +-150 to 210ca. 2 to 4 weeks

Phase IIDay 210 to 2155 days

Phase IIIDay 229 to 236ca 2 day

Awaiting HA comments

Negotiation of Translations

Day 232

This slide shows a schematic representation and the length or size of each box representing a process step is not intended to be proportional to the timescale depicted.

Finalize Trans-lations

Type II

NCE

Day +5Day +19

Day +22

Day +44

Day 0

Opinion Decision

Day 60(90)

Laun

ch

EMA

Applicant (MAA)

AbbreviationsMAA = Marketing Authorization Applicant)HA = Health authorityMS= Member State (EU)NCE = New Chemical Entity

Day 229

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Major Linguistic Activity Points

○ New Marketing AuthorizationDay 150 Pre-Opinion

short beforeOpinion(DAY 210)

HA Comments

Always Only if changes to baseline occurred

Always

Day 180

Only if changes to translationsoccurred

Only if changes to baseline occurred

Day 40(70) OpinionDAY 60(90)

HA CommentsDay +19

AlwaysOnly if changes to translationsoccurred

Start translationearly if needed

• Type II Variation

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Labeling Process/Stakeholders

What is the Solution?

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Content Preparation

Linguistic Source Analysis

Review & analysis of existing materials to clarify linguistic questions

Develop Translation guidelines ensuring compliance with latest standards to ensure a “fix once use all” principle

Gathering and validating linguistic reference materials

Linguistic Alignment & Strategy

TM Alignment

Glossary Development (aligning with approved regulated term bases)

Define TM Strategy

Process & Training

Define process workflow from Central Labeling to Affiliate to Translators to Regulators

Train & educate stakeholders on the linguistic tools and how it makes their life easier

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Multilingual Labeling System components

Multilingual Labeling System

Workflow & Task

Automation

Database of Translations

End-to-End Synchronization

Foundation: Processing of Microsoft Word Documents

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Multilingual Labeling System components

Why is it Valuable?

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Multilingual Labeling Solution – 5 Key BenefitsReduce Workload for Global Labeling and Affiliates

SDL Business Case

1. Efficiently manage frequent label changes 50% less work identifying changes15% less repair work

2. Eliminate manual target language formatting work

Overall: 96% process improvement

3. Lower translation workload 50% less work = cost

4. Simplify review Increase reviewer efficiency by 20%

5. Eliminate communication overhead Triple staff output

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SDL Multilingual Labeling Solution1. WorldServer Global Labeling solution

- Developed over the past 2 years to address complex localization process for Pharmaceutical drug labeling

- Very different than medical equipment translation requirements

2. Based on proven products

- SDL WorldServer (Translation Management System)

- SDL TRADOS Studio (Translation Editor)

3. Leverages 10 years of Labeling experience at SDL

- 6 PIM implementations

- Co-operation with EFPIA, EMA, Local Regulators

4. True Enterprise Solution

- Highly scalable system

- Integrations with Content Management systems and other Enterprise software products

SDL Trados Studio

Translation and Reviewer Editor +

SDL WorldServer

Browser Based Translation Management System (TMS)

Unifying theCustomer Experience

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Challenges, Trends and Solutions

○ Diagnostics and mean time to repair (for device and machines)– Improve findability of solutions, reduce repair time

○ Difficult for companies to get product claims approved by FDA– When claims are approved reuse as much as possible across channels

– Integrated story between doc and web is applicable

○ Shift towards telemedicine– Utilizing digital to reach rural customers

– Emerging markets like Community Health Centers

○ Using Web daily to gather health, medical or prescription drug info– 86 percent of physicians in the United States

– 82 percent of physicians in Europe use the.

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Analysts Describe It As The Problem of Unified Customer Experience

But the problem is actually more complex than this

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TOO MUCH CONTENT

• Content not targeted for task to complete

• 10% of content gets 80% of traffic

• Content not easy to contextualize or personalize

• Downstream insights don’t make it back up as feedback loops

SILO’D CONTENT

• Companies often let their internal silos and BU’s dictate customer experience, which appears fragmented to the customer with information, billing, Website, branding.

• No feedback loops from customers to content developers

INCONSISTENT CONTENT

• Customers have inconsistent experience across channels

• Content gets replicated and duplicated

• Difficult to minimize flood of content

• Not in the language required

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Towards a Unifed Customer Experience

Commerce

Product & service

Marketing

Support

Content & Media

Channel Experience

Customer Profiles

Channel OptimizationCustomer optimization

Customer

• Product catalog• Category management• Merchandizing• Order fufilment

• Brand Identity• Campaigns• Loyaty programs

• Creative assets• Marketing message• Product collateral

• Channel Delivery• Personalization• Campaigns

• Segments• Contacts• Analytics

• Social communities• Brand advocates• Journey phases

• Customer care• Incident management• Knowledge bases

• Product information• Engineering CAD• Technical documents

• Needs• Behavior• Targeting

• Contextualization• Device adaptations• Journey mapping

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OutputsInputs

Current state

Future requirements

Leading practices

Strategic vision and goals

• Consistent with vision and goals

• Addresses current state issues

• Meets future needs

• Incorporates success factors

Best practices

Plan

Recommendations

Discovery

SDL Discovery Process

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Global Customer Experience Management