sdl how global life sciences leaders solve the customer experience puzzle
DESCRIPTION
Having the right global customer experience strategy that fully integrates global product labeling interactions with real world patient care is critical for beating competitors and earning your customers’ loyalty.’TRANSCRIPT
SDL Proprietary and Confidential
SDL Multilingual Labeling SolutionUnifying the Customer Experience
Presented by: Tom O’Dwyer & Chip Gettinger
May 8, 2014
2
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
Targ
et
Lan
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ag
e H
A
Com
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Rep
ly o
n T
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Lan
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om
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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