The document discusses PAREXEL's acquisition of Liquent Technologies and Services. Some key points include:
1) PAREXEL acquired Liquent on December 27th and will operate it as a stand-alone services line to offer a more complete suite of offerings.
2) The acquisition allows both companies to leverage a global footprint and regulatory expertise to provide holistic development and commercialization services.
3) Liquent will enhance PAREXEL's regulatory services and enable it to provide a full platform for product development and commercialization.
This is the agenda and brochure for Pharma IQ's upcoming Regulatory Information Management conference on the 2nd and 3rd of March in London.
This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.
Harness Your Clinical and Financial Data with an Enterprise Health Informat...Perficient, Inc.
The importance of Enterprise Health Information Exchange (EHIE) as a key way to empower your physicians and patients and demonstrate meaningful use of electronic health records:
- Present the business case for EHIE as an important architecture that matters to progressive health systems
- Take a look at some of the market-leading EHIE architectures and products
- Provide real exam...ples of organizations that are using EHIE to improve their operations
This is the agenda and brochure for Pharma IQ's upcoming Regulatory Information Management conference on the 2nd and 3rd of March in London.
This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.
Harness Your Clinical and Financial Data with an Enterprise Health Informat...Perficient, Inc.
The importance of Enterprise Health Information Exchange (EHIE) as a key way to empower your physicians and patients and demonstrate meaningful use of electronic health records:
- Present the business case for EHIE as an important architecture that matters to progressive health systems
- Take a look at some of the market-leading EHIE architectures and products
- Provide real exam...ples of organizations that are using EHIE to improve their operations
Disaster Recovery and Business Continuity for Your Clinical and Safety SystemsPerficient, Inc.
Your systems are up and running. You have no issues. It’s business as usual and all is as it should be. Then, suddenly, it’s not. A flood, an earthquake, a tornado or a fire threatens your organization’s ability to continue operating. Systems are offline, critical business processes have stalled. What damage has been inflicted? How long until you can recover? What do you do in the meantime? These are questions that no organization can properly answer without proper planning and testing.
The implications of an unplanned and unprepared-for event can be devastating to a company, as well as to the patients it serves. The only way to mitigate such risks is through comprehensive planning and testing.
Sean Bernard, lead business consultant in Perficient's life sciences practice, discussed why business continuity and disaster planning are so critical to life sciences companies, and shares best practices for preparing your company for the unforeseen.
Leveraging Technology to Empower Patients and Reduce Healthcare CostsPerficient, Inc.
Telehealth, once reserved for the chronically ill, is now being used to drive increased revenue by creating services that scale beyond traditional geographic boundaries.
Perficient and KP OnCall discussed how telehealth is impacting healthcare and how the nation’s leading telehealth provider is leveraging innovative technologies to:
-Reduce patient visits and lower healthcare costs
-Empower patients through self-treatment
-Deliver alternate methods of patient/provider communication
-Manage symptoms and medical conditions for the patients and populations they serve
-Generate data-driven insights
ACO = HIE + Analytics - a Healthcare IT PresentationPerficient, Inc.
With the release of the Accountable Care Organization (ACO) regulations, healthcare providers must be able to identify, access, and seamlessly share patient information to drive efficiencies and enjoy a potential share in ACO program incentives. Additionally, more than half of the 93 draft National Committee for Quality Assurance (NCQA) ACO measures are also Meaningful Use measures, which further elevates the need to achieve meaningful use stage 2 or higher.
Given these goals, success will ultimately depend on an organization’s ability to share patient data at the point of care and its ability to gain meaning from historical and longitudinal data for use in managing population health. Healthcare organizations will need to give focused attention to the IT strategies, appropriate architectures, and roadmaps they will use to move from desired state to reality.
We discuss the practical architectural approach for creating an ACO. As Health Information Exchanges (HIEs) evolve into their second generation, they are able to the support the functional ACO tasks of delivering and managing care for a defined population, accept payment, distribute savings to participants, and perform disease management with predictive modeling to improve outcomes. We will also discuss the need to achieve meaningful use stage 2 or higher and the data/analytics requirements for ACO participants.
Presenter Martin Sizemore is the Director of Healthcare Strategy for Perficient. Martin has been a consultant and trusted advisor to CEOs, COOs, CIOs and senior managers for global multi-national companies and healthcare organizations, and is a certified Enterprise Architect with specialized skills in Enterprise Application Integration (EAI) and Service Oriented Architecture (SOA).
HIMSS Analytics, with a goal of helping healthcare organizations understand and advance healthcare analytics, has developed the Adoption Model for Analytics Maturity (AMAM) published here on www.SlideShare.net for healthcare industry reference.
This 8 stage international prescriptive analytics oriented maturity model offers an easy assessment and a detailed industry specific road map to help healthcare providers interested in analytics advance their capabilities.
For further information please see www.HIMSSAnalytics.org
How to Load Data More Quickly and Accurately into Oracle's Life Sciences Data...Perficient, Inc.
Sponsors and CROs know the value of having a consolidated and regulatory-compliant data warehouse, such as Oracle’s Life Sciences Data Hub (LSH), as well as the importance of consistently loading data into that warehouse quickly and accurately.
However, as data structures from the source files change over time, it can be very time consuming to modify the data structure in the warehouse itself. Additionally, for the large groups of SAS datasets that are typical for a clinical trial, the out-of-the-box load times can be quite long, as the data is loaded one set at a time.
Perficient has the answer. In this webinar, we discussed and demonstrated an autoloader tool that greatly simplifies the data loading process for LSH. We showed how the autoloader can automatically load files, detect metadata changes, upgrade target structures, and load data, all with no human intervention. In addition, we demonstrated how Perficient’s autoloader tool can load multiple datasets in parallel to minimize load times.
Going Beyond the EMR for Data-driven Insights in HealthcarePerficient, Inc.
Join Dr. Marcie Stoshak-Chavez, MD, FACEP, Director of Healthcare Strategic Advisory Services at Perficient and Mr. J.D. Whitlock, Director of Clinical & Business Intelligence at Catholic Health Partners to learn how analytics is being used to measure and monitor performance and provide service-line directors and financial administrators with reporting and analysis that enhances clinical care processes and business operations.
Learn how clinicians and administrators armed with the data-driven insights from the EMR and beyond can:
Derive meaningful insights for care delivery by analyzing clinical, financial and operational data
Collaborate more effectively and improve quality of care by securely sharing insights among providers
Meaningfully measure and understand performance across key Federally mandated measures and take prescribed action
Stay on top of shifts in regulatory policy that impact reimbursements and quality requirements
Healthcare Reform & Physician Loyalty: What Can CRM Do To Support ACOs?Perficient, Inc.
Martin Sizemore, Enterprise Architect at Perficient, and Lisa Anderson, CRM Solution Architect at Perficient, discuss Consumerism in Healthcare, Physician Practice Challenges & Alignment, and provide a Physician Loyalty Campaign Demo
Solving the Data Management Challenge for HealthcareDelphix
Need a proven blueprint to fast-track application development in your healthcare organization? With triple-digit growth, 3,000+ databases and over a petabyte of data, Molina Healthcare needed a way to accelerate application development and drive digital transformation.
Success meant slashing time to provision new dev and test environments in half, putting self-service data access in the hands of application teams―and doing it all without taking an eye off data security and HIPAA compliance.
2013 Year of Pharmaceutical Serialization - Get it RightMichael Stewart
Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.
How Northwestern Medicine is Leveraging Epic to Enable Value-Based CarePerficient, Inc.
Value-based care and payment reform are prompting hospitals and healthcare providers to more closely manage population health. Hospitals and health systems rely on technology and data to outline the characteristics of their population and identify high-risk patients in order to manage chronic diseases and deliver enhanced preventative care.
Our webinar covered how Cadence Health, now part of Northwestern Medicine, is leveraging the native capabilities of Epic to manage their population health initiatives and value-based care relationships across the continuum of care.
Our speakers:
-Analyzed how Epic’s Healthy Planet and Cogito platforms can be used to manage value-based care initiatives.
-Examined the three steps for effective population health management: Collect data, analyze data and engage with patients.
-Covered how access to analytics allows physicians at Northwestern Medicine to deliver enhanced preventive care and better manage chronic diseases.
-Discussed Northwestern Medicine’s strategy to integrate data from Epic and other data sources.
Pharmaceutical Serialization Strategic Planning GuideMichael Stewart
Strategic planning guide to begin the serialization process and identify ROI and business value day 1. The best way to get value is to build it into the front end planning process. This take no prisoners paint by numbers Guide should be the foundation for any pharmaceutical companies serialization planning strategy.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Driving Home Health Efficiency through Data AnalyticsCitiusTech
This whitepaper highlights how data analytics can help track key performance indicators to drive clinical, financial and operational efficiency to improve quality of home health in an efficient manner.
Maetrics: The ROI of Good Quality & ComplianceGeneris
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One.
Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit.
Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017.
Disaster Recovery and Business Continuity for Your Clinical and Safety SystemsPerficient, Inc.
Your systems are up and running. You have no issues. It’s business as usual and all is as it should be. Then, suddenly, it’s not. A flood, an earthquake, a tornado or a fire threatens your organization’s ability to continue operating. Systems are offline, critical business processes have stalled. What damage has been inflicted? How long until you can recover? What do you do in the meantime? These are questions that no organization can properly answer without proper planning and testing.
The implications of an unplanned and unprepared-for event can be devastating to a company, as well as to the patients it serves. The only way to mitigate such risks is through comprehensive planning and testing.
Sean Bernard, lead business consultant in Perficient's life sciences practice, discussed why business continuity and disaster planning are so critical to life sciences companies, and shares best practices for preparing your company for the unforeseen.
Leveraging Technology to Empower Patients and Reduce Healthcare CostsPerficient, Inc.
Telehealth, once reserved for the chronically ill, is now being used to drive increased revenue by creating services that scale beyond traditional geographic boundaries.
Perficient and KP OnCall discussed how telehealth is impacting healthcare and how the nation’s leading telehealth provider is leveraging innovative technologies to:
-Reduce patient visits and lower healthcare costs
-Empower patients through self-treatment
-Deliver alternate methods of patient/provider communication
-Manage symptoms and medical conditions for the patients and populations they serve
-Generate data-driven insights
ACO = HIE + Analytics - a Healthcare IT PresentationPerficient, Inc.
With the release of the Accountable Care Organization (ACO) regulations, healthcare providers must be able to identify, access, and seamlessly share patient information to drive efficiencies and enjoy a potential share in ACO program incentives. Additionally, more than half of the 93 draft National Committee for Quality Assurance (NCQA) ACO measures are also Meaningful Use measures, which further elevates the need to achieve meaningful use stage 2 or higher.
Given these goals, success will ultimately depend on an organization’s ability to share patient data at the point of care and its ability to gain meaning from historical and longitudinal data for use in managing population health. Healthcare organizations will need to give focused attention to the IT strategies, appropriate architectures, and roadmaps they will use to move from desired state to reality.
We discuss the practical architectural approach for creating an ACO. As Health Information Exchanges (HIEs) evolve into their second generation, they are able to the support the functional ACO tasks of delivering and managing care for a defined population, accept payment, distribute savings to participants, and perform disease management with predictive modeling to improve outcomes. We will also discuss the need to achieve meaningful use stage 2 or higher and the data/analytics requirements for ACO participants.
Presenter Martin Sizemore is the Director of Healthcare Strategy for Perficient. Martin has been a consultant and trusted advisor to CEOs, COOs, CIOs and senior managers for global multi-national companies and healthcare organizations, and is a certified Enterprise Architect with specialized skills in Enterprise Application Integration (EAI) and Service Oriented Architecture (SOA).
HIMSS Analytics, with a goal of helping healthcare organizations understand and advance healthcare analytics, has developed the Adoption Model for Analytics Maturity (AMAM) published here on www.SlideShare.net for healthcare industry reference.
This 8 stage international prescriptive analytics oriented maturity model offers an easy assessment and a detailed industry specific road map to help healthcare providers interested in analytics advance their capabilities.
For further information please see www.HIMSSAnalytics.org
How to Load Data More Quickly and Accurately into Oracle's Life Sciences Data...Perficient, Inc.
Sponsors and CROs know the value of having a consolidated and regulatory-compliant data warehouse, such as Oracle’s Life Sciences Data Hub (LSH), as well as the importance of consistently loading data into that warehouse quickly and accurately.
However, as data structures from the source files change over time, it can be very time consuming to modify the data structure in the warehouse itself. Additionally, for the large groups of SAS datasets that are typical for a clinical trial, the out-of-the-box load times can be quite long, as the data is loaded one set at a time.
Perficient has the answer. In this webinar, we discussed and demonstrated an autoloader tool that greatly simplifies the data loading process for LSH. We showed how the autoloader can automatically load files, detect metadata changes, upgrade target structures, and load data, all with no human intervention. In addition, we demonstrated how Perficient’s autoloader tool can load multiple datasets in parallel to minimize load times.
Going Beyond the EMR for Data-driven Insights in HealthcarePerficient, Inc.
Join Dr. Marcie Stoshak-Chavez, MD, FACEP, Director of Healthcare Strategic Advisory Services at Perficient and Mr. J.D. Whitlock, Director of Clinical & Business Intelligence at Catholic Health Partners to learn how analytics is being used to measure and monitor performance and provide service-line directors and financial administrators with reporting and analysis that enhances clinical care processes and business operations.
Learn how clinicians and administrators armed with the data-driven insights from the EMR and beyond can:
Derive meaningful insights for care delivery by analyzing clinical, financial and operational data
Collaborate more effectively and improve quality of care by securely sharing insights among providers
Meaningfully measure and understand performance across key Federally mandated measures and take prescribed action
Stay on top of shifts in regulatory policy that impact reimbursements and quality requirements
Healthcare Reform & Physician Loyalty: What Can CRM Do To Support ACOs?Perficient, Inc.
Martin Sizemore, Enterprise Architect at Perficient, and Lisa Anderson, CRM Solution Architect at Perficient, discuss Consumerism in Healthcare, Physician Practice Challenges & Alignment, and provide a Physician Loyalty Campaign Demo
Solving the Data Management Challenge for HealthcareDelphix
Need a proven blueprint to fast-track application development in your healthcare organization? With triple-digit growth, 3,000+ databases and over a petabyte of data, Molina Healthcare needed a way to accelerate application development and drive digital transformation.
Success meant slashing time to provision new dev and test environments in half, putting self-service data access in the hands of application teams―and doing it all without taking an eye off data security and HIPAA compliance.
2013 Year of Pharmaceutical Serialization - Get it RightMichael Stewart
Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.
How Northwestern Medicine is Leveraging Epic to Enable Value-Based CarePerficient, Inc.
Value-based care and payment reform are prompting hospitals and healthcare providers to more closely manage population health. Hospitals and health systems rely on technology and data to outline the characteristics of their population and identify high-risk patients in order to manage chronic diseases and deliver enhanced preventative care.
Our webinar covered how Cadence Health, now part of Northwestern Medicine, is leveraging the native capabilities of Epic to manage their population health initiatives and value-based care relationships across the continuum of care.
Our speakers:
-Analyzed how Epic’s Healthy Planet and Cogito platforms can be used to manage value-based care initiatives.
-Examined the three steps for effective population health management: Collect data, analyze data and engage with patients.
-Covered how access to analytics allows physicians at Northwestern Medicine to deliver enhanced preventive care and better manage chronic diseases.
-Discussed Northwestern Medicine’s strategy to integrate data from Epic and other data sources.
Pharmaceutical Serialization Strategic Planning GuideMichael Stewart
Strategic planning guide to begin the serialization process and identify ROI and business value day 1. The best way to get value is to build it into the front end planning process. This take no prisoners paint by numbers Guide should be the foundation for any pharmaceutical companies serialization planning strategy.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
Applying Technologies Across the End-to-End Pharmacovigilance Process to Incr...MyMeds&Me
MyMeds&Me CEO Andrew Rut and Oracle Health Science's Director of Safety Analytics, Michael Braun-Boghos review the positive impacts of technology on current pharmacovigilance processes.
Driving Home Health Efficiency through Data AnalyticsCitiusTech
This whitepaper highlights how data analytics can help track key performance indicators to drive clinical, financial and operational efficiency to improve quality of home health in an efficient manner.
Maetrics: The ROI of Good Quality & ComplianceGeneris
On October 5th, 2016 at the American Medical Device Summit in Chicago, Generis welcomed Maetrics to the speaker panel on Day One.
Ed Roach brings nearly 20 years of experience in the life sciences industry to the panel while adding his wealth of knowledge on Quality Systems and Quality Assurance, Validation, Corrective and Preventive Actions (CAPS), Root Cause Investigation, Change Management, and 483/Warning Letter Remediation to the American Medical Device Summit.
Generis is thrilled that Maetrics will be returning to Chicago for the American Medical Device Summit on October 4th and 5th in 2017.
Diaspark healthcare offers software product development, compliance implementation and mobility services to healthcare software vendors (EMR/EHR/HIE/HIS/ Home Healthcare), life science companies and non-profits. Right from developing key EHR software modules spanning CPOE, Patient Portals, eRX(ePrescription), eMAR, Clinical DSS, labs to building healthcare mobile apps over iOS, Android, Blackberry that even interact with health devices, we work as an extended enterprise to software product vendors and life science companies.
A Profitability and Cost Management Strategy for Healthcare ProvidersPerficient, Inc.
Experts from Perficient and Oracle discussed how leveraging advanced analytics to manage population health, develop risk models, and examine clinical outcomes based on cost will enable Accountable Care and improve the quality of care.
Attendees learned how to link strategies to plans and then execute and monitor financial and operational results against goals as we explored:
• How to apply analytics to drive enterprise-wide performance improvement
• An innovative approach to link costing, patient analytics, and variance analysis to productivity management in an Accountable Care Organization
• An overview of Hyperion Profitability & Cost Management (PCM) solution differentiators, including micro costing
• How the PCM solution relates to the Oracle enterprise performance management and enterprise health analytics platforms
• A demonstration of multiple reports and dashboards such as patient-level P&L and revenue and cost margin by payer
Healthcare Business Intelligence for Power UsersPerficient, Inc.
The Healthcare industry is accustomed to volumes of clinical and administrative data. Business intelligence helps convert these large amounts of data into actionable insights to reduce costs, streamline processes, and improve healthcare delivery. Our first webinar, “An Introduction to Business Intelligence for Healthcare,” introduces business intelligence in healthcare and common concepts.
In the second of this series of two webinars, Health BI Practice Manager, Mike Jenkins addresses:
- The BI Maturity Level
- Examples of Levels 3 and 4
- Attaining Level 5
Microsoft: A Waking Giant in Healthcare Analytics and Big DataDale Sanders
Ten years ago, critics didn’t believe that Microsoft could scale in the second generation of relational data warehouses, but they did. More recently, many of these same pundits have criticized Microsoft for missing the technology wave du jour in cloud offerings, mobile technology, and big data. But, once again, Microsoft has been quietly reengineering its culture and products, and as a result, they now offer the best value and most visionary platform for cloud services, big data, and analytics in healthcare.
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
3
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
4
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.
12
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
1
One Company
One Fully-Integrated eClinical Suite
One Central Regulatory Information Source
One Focus on Delivery
RIM
Platform
Confidential