2. Liquent Acquired by PAREXEL
• December 27 Announcement – PAREXEL fully acquires Liquent
• Operate as a stand-alone services line under the Perceptive Informatics group
• No changes within Liquent team and responsibilities
• Leverage opportunities for synergy as identified
• Benefits of acquisition:
1. Allows us to offer a more complete suite of offerings to meet your needs
2. We now have a true global footprint
3. We will benefit from the PAREXEL’s exceptional worldwide regulatory affairs
expertise, as well as from its end-to-end client focus.
At the same time, we will enhance PAREXEL’s Regulatory services and enable it to
provide a true holistic development, regulatory and commercialization platform and
associated services.
Confidential
3. Why Did PAREXEL Acquire Liquent?
PAREXEL’s strategic clients want PAREXEL to provide a full range of
development and commercialization services
Allows Perceptive to broaden their eClinical software technology platform
to include Regulatory providing a full end to end platform solution
Complements PAREXEL Consulting’s (PCMS) regulatory affairs offerings
Successful past partnering with Liquent in providing regulatory services
and use of Liquent technology
Confidential
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4. Why PAREXEL?
• Better positions Liquent to capitalize on the market opportunities
across Regulatory Information Management
• Can now provide a broader range of integrated capabilities
• Allows Liquent to broaden its end to end vision within regulatory to now include
clinical operations
• Allows Liquent to provide a complete regulatory outsourcing solution by leveraging
PCMS’ Regulatory Affairs capabilities
• Liquent can now extend our solutions globally by leveraging
PAREXEL’s global reach and vast client base
• Strong cultural fit and business model alignment
• Same industry focus and business model
• Expanded career path opportunities for our employees
Confidential
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5. Full Range of In House Expertise
Clinical Clinical Strategy &
Technology Communication
Research Logistics Consulting
• Phase I-IV • Global Supply Chain • Medical Imaging • Product Development • Medical Education
Management & Regulatory Affairs & Communications
• Project Management • IVRS/IWRS
• Supply Strategy, • Strategic Compliance • Meetings, Events
• Site Management • EDC – DataLabs®
Forecasting & Simulation & Risk Management & Exhibits
• Patient & Investigator • Integration Services
• Storage & Distribution • Clinical & Manufacturing • Educational Services
Recruitment
• CTMS – IMPACT®
• IMP and NIMP Supplies • Quality Process • Scientific Publications
• Data Management
• ePRO Consulting
• Ancillary Supplies
• Biostatistics
• MyTrialsTM • Reimbursement & Patient
• Lab Logistics &
• Bioanalysis Assistance Programs
Sample Management • eLogistics Suite
• Medical Services • Commercialization
• Import/Export Management • Liquent InSight RIM
Technology • Electronic Submissions
Confidential
6. Industry Trends From Recent Surveys
Decline in new product approvals, increased generic
competition, and price pressures are driving:
• Focus on emerging markets to increase revenue from existing products
• Increased interest in flexible staffing/resourcing and technology approaches as
companies re-evaluate what is core and non-core
Evolution of industry standards and regulations remains slow
and the impact can be unpredictable (e.g. XEVMPD, RPS)
Most companies are “re-thinking” how they are doing day-to-day
business and what is truly core to the organization
Concerns with drug safety and compliance with evolving
regulations requires global access to authoritative
registration and product information
• Software and service based solutions will continue to converge into a broader
definition of Regulatory Information Management
Overall, our customers' world is becoming more complex, not
less
Confidential
7. Evolving Regulatory Landscape
CTD: Common Technical Document
eCTD: Electronic Common Technical
Document
XEVMPD: Extended EudraVigilance Medical
Product Dictionary
RPS: Regulatory Product Submission
IDMP: Identification of Medicinal Products
Complexity
2015: RPS and IDMP
2012: XEVMPD
2009: eCTD
2004: CTD
Level of Detail Required
Confidential
8. Key Business Drivers For Change
• Improved regulatory compliance
• Improved information quality
• Reduced time to find and verify regulatory information in
order to consume with confidence (efficiency)
• Improved planning and resource allocation
• Reduced complexity of tracking regulatory information for
large, global product portfolios
• Reduced time for product release into clinical or
commercial
• Harmonized capabilities across diverse divisions (e.g. Rx,
Vaccines, Biologics, Devices, etc.)
• Enhances process-centric thinking and collaboration
across functions and partners
Confidential
9. Regulatory Information Management (RIM)
Effective and efficient collection, storage, retrieval and
communication of regulatory information
Regulatory information includes metadata and content
Regulatory Information Management involves:
• Defining product authorization targets DEFINE PRODUCT
AUTHORIZATION TARGETS
• Where do we want to be registered and
• Managing regulatory/submission plan when?
• What are the regulatory requirements?
• Who is responsible?
• Have we created a submissions plan?
• Creating/gathering submission information
• Producing/submitting submission output MANAGE REGISTRATIONS
• What is approval status?
• What products, suppliers, etc. were
MANAGE REGULATORY
SUBMISSION PLAN
• What content is needed?
approved where?
• What resources are required?
• What commitments were made?
• When will it be available and who is
• Managing the registration • What changes are planned and when? responsible?
PRODUCE / SUBMIT CREATE / GATHER
SUBMISSION OUTPUT SUBMISSION
• What content is missing? INFORMATION
• What reviews / approvals are still • Has this content been used
needed? previously?
• Is output compliant with regulatory • What authoring standards must be
expectations and requirements? followed?
• What internal reviews are needed?
Confidential
10. Traditional Approach to Regulatory Data Management
Pressure Points /
Traditional Approach Key Strategies
M&A and In-Licensing
Submission & Promotional
Global Label
Publishing Registration Material
Management New Geographies
Management Management
New Indications
Enterprise Document Management
(Research, Development, Regulatory, Commercial, M&S, Corporate)
Headcount Reductions
Electronic and Paper
Archives Documents
Da ta
Rationalizing IT Systems
Confidential
11. Value of Integrated RIM Platform
Short Term
• Drives harmonization
• Promotes standardization
• Simplifies connectivity with external partners
• Simplifies system change process
• Reduces integration costs
Longer Term
• Agility to respond to regulatory landscape changes
• Enhances impact of innovation from application-level to platform-
level
• Increases internal visibility of business value
Confidential
12. Focus on Regulatory Information Management
Liquent’s Vision – to be the premier provider of a scalable, regulatory information
management platform and associated regulatory & clinical services that can be
leveraged throughout a client organization in support of the development,
registration, and manufacturing processes.
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Confidential
13. Liquent InSight
Liquent InSight is a purpose-built, enterprise class, comprehensive integrated platform
of modular software solutions to support RIM needs of Life Sciences companies.
• Accelerates product launches
• Supports geographic expansion facilitating movement towards simultaneous submissions to multiple
regulatory authorities
• Eliminates redundant regulatory information systems and homegrown solutions
• Avoids duplication of efforts and maximizes use of available resources
• Streamlines ability to respond to global health authorities’ inquires through global Q&A database
• Reduces likelihood of expensive product recalls and fines through harmonized data repository
Liquent InSight Platform
InSight for InSight for InSight for InSight for InSight for
Submission Publishing Viewing Registration XEVMPD
Management Applications for s Collects XEVMPD
Enterprise access, Plan, track and
Plans and publishing manage activities data and creates
view and
manages eCTD, NeeS, and registration compliant XEVMPD
collaborative
submission and and Paper output details of a product, submissions with
review of
dossier content and including granular import of XEVMPD
submissions
related activities product details acknowledgements
Confidential
14. Value of InSight
Provides a clear view to the entire user base from Executives
to Operations
As product and submission plans emerge, everyone sees the same picture
Executives can see plans at a high level
What’s in the regulatory pipeline?
How are the plans tracking?
When are we expecting approvals that will add additional revenue to the
company?
Global clinical trial status and compliance view
Managers can begin planning at the right time, and continue
throughout the project
When is it time to start resourcing?
How is the project progressing?
How are things tracking across various projects?
Confidential
15. Enabling a Comprehensive
Product Lifecycle Management Framework
MyTrials
Start-Up Execution Reporting and
Submission
Trial Level Patient Image
Feasibility/Site
Regulatory Recruitment & Acquisition
Identification Reporting
Submission Retention & Review
and
Regulatory
Site Monitoring Data Review Information
Supplies Site Management
Management &
Start-Up
Safety Monitoring Acquisition
Collection & Management Systems
RIM
Platform
Confidential
16. The Power of One: Making it Easy to Collaborate
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One Company
One Fully-Integrated eClinical Suite
One Central Regulatory Information Source
One Focus on Delivery
RIM
Platform
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