PAREXEL CONSULTING. Your strategic guide to faster, smarter drug development

Size: px
Start display at page:

Download "PAREXEL CONSULTING. Your strategic guide to faster, smarter drug development"

Transcription

1 PAREXEL CONSULTING Your strategic guide to faster, smarter drug development

2 YOUR JOURNEY. OUR MISSION. Addressing your needs throughout the drug development lifecycle

3 On the journey to cure disease, the challenges can be daunting. As pressure builds on available healthcare resources, regulators are applying higher levels of scrutiny. Access to drugs is more consistently dependent on demonstration of value and effectiveness. In a constantly evolving landscape, biopharmaceutical and medical device manufacturers are looking ever more critically at a drug development process largely conceived in an era of blockbusters. Innovation can be applied to solve the challenges of science and technology, but achieving regulatory and reimbursement approval demands more. We can help ensure commercial success by: Incorporating the needs and requirements of key stakeholders early in the development process Demonstrating and communicating efficacy, safety and value throughout the product lifecycle Developing and implementing innovative operating models and processes to drive efficiency and maximize portfolio value 1

4 OUR APPROACH PAREXEL Consulting is your strategic guide across the product lifecycle, overcoming the challenges, and accelerating imperatives to gain and maintain optimal product market positioning. Our scientific, regulatory, and commercial expertise put best practice standards to work for biopharmaceutical and medical device companies large and small, designing solutions for the complexities of an everchanging global marketplace. GLOBAL HARMONIZATION Our global footprint is significant, but it is global harmonization that allows us to provide high-level consulting, with the benefit of local expertise, to inform the best possible solutions to our clients most complex challenges across the world. PERVASIVE OPTIMIZATION Pervasive optimization and innovation refers to our constant pursuit to simplify the journey and focus on what s next? throughout the product development lifecycle. It s not just what we do; it s how we do it that distinguishes our consultancy services. THE BIGGER JOURNEY Whether it s strategic consulting on matters involving regulatory approval and compliance, development of a cost-effectiveness model, or a strategic partnership that allows for deeper collaboration throughout the development process, our consultative mindset makes us problem solvers and true partners from start to finish. 2

5 OUR SERVICES PAREXEL Consulting s integrated services translate client vision to bold solutions throughout the development lifecycle. As your strategic partner and guide, we draw upon our unique fusion of expertise to effectively chart the best course for the future. We understand the need to differentiate your product today and anticipate how to sustain that competitive edge tomorrow through to the next decade and beyond. PRE-IND IND/ CTA PHASE I PHASE II PHASE IIB PHASE III NDA/MAA (CTD) PERI-APPROVAL/ PHASE IV INTEGRATED PRODUCT DEVELOPMENT CONSULTING SCIENTIFIC REGULATORY BUSINESS Our focus is on maximizing the value of your portfolio, leveraging our unique fusion of scientific, regulatory, and commercial expertise. 3

6 INTEGRATED PRODUCT DEVELOPMENT In today s marketplace, biopharmaceutical and medical device companies must leverage the global environment to develop products efficiently, gain market advantage, and realize a return on investment. While opportunities abound, navigation can be complex, most notably given the changing topography at local, regional, and global levels. ACCELERATING TIME TO MARKET WITH INTELLIGENCE, DATA AND STRATEGIC INSIGHTS Sound global product and portfolio strategies require both specialized expertise and local resources. PAREXEL Consulting supports clients in the prioritization of assets and portfolios including determination of the most optimal regulatory and clinical paths available. Enhanced speed of patient recruitment and the potential for lower clinical trial costs are just two of the benefits your company may realize. PAREXEL Consulting s expert teams provide the intelligence, data and strategic insight necessary to prioritize portfolio development, shape global strategies, and map optimal clinical and regulatory pathways that speed time to market. Led by an extensive team of former healthcare professionals and regulators from around the world, we are an industry leader in strategic product development services, able to provide you with the data and insights you need to accelerate your products through regulatory and development hurdles, achieve regulatory approval, and support post-approval lifecycle management to enhance and extend commercial success. Key Offerings Global product development strategy, planning and execution Regulatory strategy and intelligence services Health authority/agency consulting, advisory and liaison services Clinical trial applications (INDs, CTAs, CTNs) Regulatory submissions Comprehensive labeling services Clinical and nonclinical development consulting Global regulatory planning Specialized expertise to speed approval New product acquisition support 4

7 REGULATORY OUTSOURCING Life sciences companies can expend up to two-thirds of their regulatory resources on maintaining products that have already been approved and are on the market. These maintenance activities provide little competitive advantage but are critically important to maintain sales. OPTIMIZING PERFORMANCE AND PIPELINE VALUE Outsourcing has become a key competitive strategy in the life sciences industry, enabling clients to focus their expertise on core competencies and innovation while moving to variable cost models via a more agile workforce. By applying multidisciplinary expertise both internally and externally where it is needed most, regulatory outsourcing can reduce costs, improve processes, and accelerate approvals. PAREXEL s Regulatory Outsourcing Services leverage an operating model specifically designed to deliver a highquality, cost-effective solution for lifecycle maintenance of established products. PAREXEL uniquely combines enabling technology, operational expertise, and both global and local market regulatory intelligence to deliver these services. The result is a scalable and flexible outsourcing model that results in predictable year-over-year savings and addresses the regulatory complexities, increased workloads, and limited budgets that are facing the industry. Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports, and other product lifecycle maintenance tasks. As your trusted partner, delivering a net positive effect on your bottom line, PAREXEL s Regulatory Outsourcing Services can help you stay focused on core competencies while improving processes to expedite your product s time to market. Operational and cost efficiencies, process improvement, and the ability to align available human capital to more strategic regulatory activities are just some of the key benefits. Key Offerings Submission management Regulatory dossier compilation, publishing and dispatch Investigational filings and lifecycle maintenance Market authorization filings and lifecycle maintenance Post-approval lifecycle maintenance Report compilation and publishing Content creation and document services 5

8 STRATEGIC GCP/GMP COMPLIANCE AND RISK MANAGEMENT There s nothing more harmful to a company than having a product pulled off the market or having a high-profile approval delayed. Regulatory bodies around the world have become more aggressive in their enforcement efforts. Setbacks associated with routine FDA inspections, as well as more serious Warning Letters and Consent Decrees, are costly and often result in approval delays, product recalls, harm to reputation and adverse impact on shareholder value. Non-compliance is an expense that no biopharmaceutical company can afford. 6

9 DRIVING VALUE BY MANAGING RISK PAREXEL s experienced team of former FDA investigators and quality professionals proactively minimize risk as well as effectively respond to urgent compliance challenges. Our approach is grounded in the belief that compliance and quality should be managed as any other critical business issue. Proper quality management and a state of regulatory compliance will result in a decrease in direct costs such as rejects, and indirect costs such as adverse events and recalls. PAREXEL Consulting offers compliance solutions for small and large companies, from loaned executives to global audits, ad-hoc advice or inspection readiness training. We help our partners manage risk effectively in global markets to protect and grow product and company reputation and value by developing practical, tailored plans that align global quality capabilities with business strategy. Our team of experts includes renowned former regulators who know how to institute proactive compliance programs and have a strong track record helping companies out of regulatory crises. They are well versed in biopharmaceutical, medical device, and diagnostic regulations, and are focused on helping you create and maintain a culture of compliance and continuous improvement. Key Offerings GxP compliance strategies GxP audits Pre-approval inspection (PAI) readiness Operational readiness and sustainability programs (mentoring) Assistance during inspections / post-inspection correspondence and meetings Assistance to legal counsel in FDA enforcement matters Due diligence of product and facility acquisitions Training in GxP compliance and topical issues 7

10 HERON COMMERCIALIZATION Optimal reimbursement, target market access, and pricing are critical challenges for manufacturers as they seek to achieve acceptable levels of return on investment after lengthy and costly development programs. Commercialization, particularly the evidence requirements of payers, however, has yet to be routinely integrated into clinical and regulatory planning. The consequence is noteworthy as many new health treatments fail to achieve their commercial potential. ELIMINATING BARRIERS TO ACCESS AND REIMBURSEMENT PAREXEL Consulting offers a bold solution in the form of HERON Commercialization. Our expertise aligns evidence development and economic evaluation with pricing, reimbursement and market access strategy. We help you discover value and opportunity early and throughout your development process. PAREXEL s Commercial Decision Pathways lay the foundation for what will ultimately quantify the differentiation of product value and effectiveness globally: Due diligence review for asset evaluation Systematic review of competitive and comparator treatments, economic analysis of market potential, epidemiologic analysis of patient populations, indication review (including sub-populations) and reimbursement/payer review in influential markets support go/no-go decision in the prioritization of drug and biologic acquisition. Evidence-based compound/indication prioritization Early health economic modeling, review of competitive and comparator products, clarification of unmet needs and epidemiologic analysis of patient sub-populations inform compound development and indication sequencing, which contribute directly to commercial success. 8

11 Clinical trial protocol, Target Product Profile and label claim development As critical milestones in the development process, each of these decision points requires trusted insights based on a review of comparators, payer coverage and data requirements, and health economic analysis of market requirements that support reimbursement and access through value demonstration and communication. Evidence and economic needs assessment and evaluation Claims analysis and budget impact combined with comparative effectiveness models, value dossiers and comparative effectiveness research translate into a powerful and rigorous evidence strategy for successful reimbursement and sustainable market access. Market access, pricing and reimbursement strategy Health Technology Assessment submission, payer value proposition development, geographically relevant market access strategies and qualitative and quantitative pricing research optimize market access by creatively addressing payer needs. Key Offerings Evidence Generation Systematic Review and Meta Analyses Health Economic Modeling Data Analytics Global Value Dossiers and Country Reimbursement and HTA Submissions Strategic Payer Communications Access Realization Health Technology Assessment Strategy and Submission Payer Value Proposition Development and Articulation Market Access Strategy Qualitative and Quantitative Pricing Evidence Assessment and Communication Aligning your commercial strategy with clinical and regulatory planning early in the development process creates the opportunity to address contemporary and forward-looking needs of key healthcare stakeholders globally, realizing maximum return on investment and the greatest potential to positively impact the patient population. 9

12 MEDICAL COMMUNICATIONS DRIVING BRAND PERFORMANCE THROUGH INTEGRATED, EVIDENCE-BASED COMMUNICATIONS One of the most tangible return on investments in the drug development process comes from the translation of complex scientific data and healthcare discoveries into effective communications that motivate both healthcare professionals and payers, drive launch excellence, and accelerate product adoption. Our Medical Communications team provides the vital support necessary to drive brand performance at each step of your journey. We translate your scientific data and healthcare discoveries into communications that motivate multiple audiences. We can help you achieve pre-launch and launch excellence 10

13 and accelerate product adoption and recommendation by healthcare professionals. The Medical Communications team is comprised of worldclass experts including scientific strategists and medical writers, clinicians, and creative production teams. Our experts ensure that your medical and/or marketing message is disseminated accurately to support product positioning and appropriately for expert engagement. Strong technical and creative expertise also ensures that data are conveyed to all target audiences in a professional and compliant manner. Key Offerings Communications planning and implementation Publications planning and implementation Scientific, clinical and health-economic writing Expert identification and engagement Exhibit support Branding and design Digital interactive media Global meetings and events management Our multi-stakeholder approach provides your product with the most effective medical communications support to succeed in the all-important launch window and help you achieve launch excellence and long-term brand success. 11

14 FROM PROJECTS TO PARTNERSHIPS ON THE PATH TO CURING DISEASE With a global presence and expertise in all aspects of the drug development journey, PAREXEL Consulting aligns clinical, regulatory, and commercial work streams while addressing specific client needs at any point in the drug development continuum. Your journey is to cure disease with efficacious, safe, and cost-effective health treatments. Our mission is to support you with talent and experience that result in faster, smarter drug development. We look forward to the opportunities. CLIENT PROFILES Emerging to Mid-sized BioPharma Specialty BioPharma Large BioPharma Medical Device/Diagnostics Drug and Biologic Generics Investment Banks and VCs Law Firms BioPharma Distributors 12

15 1,200+ NUMBER OF PROJECTS PER YEAR PAREXEL CONSULTING DELIVERS TO A VARIETY OF CLIENTS IN A BROAD RANGE OF THERAPEUTIC AND PRODUCT AREAS THERAPEUTIC AREAS Oncology Cardiovascular CNS Endocrinology/Metabolism Infectious Diseases Allergy/Immunology Pulmonology Gastroenterology Obstetrics/Gynecology Our regional leads are always available for a conversation. THE AMERICAS Jim Park EUROPE & ASIA PACIFIC Heather Alford PRODUCT AREAS Drugs Biologics Medical Devices/Diagnostics Vaccines (Prophylactic, Therapeutic, Defense) Biosimilars Generics Combination products Other

16 WHEREVER YOUR JOURNEY TAKES YOU, WE RE CLOSE BY. CORPORATE HEADQUARTERS 195 West Street Waltham, MA USA Offices across Europe, Asia and the Americas PAREXEL International Corporation. All rights reserved. Perceptive, Perceptive MyTrials, LIQUENT, ClinPhone, DataLabs and IMPACT are trademarks or registered trademarks of PAREXEL International Corporation or its subsidiaries. All other trademarks are the property of their respective owners and hereby acknowledged.

Driving Efficiency in Post-marketing Safety

Driving Efficiency in Post-marketing Safety Driving Efficiency in Post-marketing Safety The PAREXEL PACE (Peri-approval Clinical Excellence) group is a dedicated unit of late phase specialists providing a full scope of peri/post-approval services

More information

CLINICAL DEVELOPMENT OPTIMIZATION

CLINICAL DEVELOPMENT OPTIMIZATION PAREXEL CLINICAL RESEARCH SERVICES CLINICAL DEVELOPMENT OPTIMIZATION Enhancing the clinical development process to achieve optimal results ADVANCED TECHNOLOGY COMBINED WITH INTELLIGENT THINKING CAN HELP

More information

Global regulatory affairs role in the biopharmaceutical industry

Global regulatory affairs role in the biopharmaceutical industry CHAPTER TWO Global affairs role in the biopharmaceutical industry 2.1 Overview 2.2 Global affairs organization 2.3 Role of global affairs 2.4 Key functions and activities 2.5 Global strategy 2.6 Global

More information

THE WHAT AND WHY OF REGULATORY OUTSOURCING

THE WHAT AND WHY OF REGULATORY OUTSOURCING WHITE PAPER THE WHAT AND WHY OF REGULATORY OUTSOURCING Today s evolving healthcare landscape poses unprecedented challenges to biopharmaceutical companies. Consolidation, budget cuts, restructuring, globalization

More information

EARLY ECONOMIC MODELS PAY OFF IN PRODUCT DEVELOPMENT

EARLY ECONOMIC MODELS PAY OFF IN PRODUCT DEVELOPMENT AN ARTICLE FROM PAREXEL ACCESS EARLY ECONOMIC MODELS PAY OFF IN PRODUCT DEVELOPMENT Once drug developers have achieved regulatory approval with data from trials against the standard of care, they must

More information

What Lies Ahead? Trends to Watch: Health Care Product Development in North America

What Lies Ahead? Trends to Watch: Health Care Product Development in North America What Lies Ahead? Trends to Watch: Health Care Product Development in North America What Lies Ahead? for 2015 DIA has released its third annual What Lies Ahead? report, providing experts insights into the

More information

exactly. The need for efficiency in developing effective new therapeutics has never been greater.

exactly. The need for efficiency in developing effective new therapeutics has never been greater. exactly. The need for efficiency in developing effective new therapeutics has never been greater. As demands on the global healthcare system increase and treating disease becomes more complex, the research,

More information

BEST PRACTICES RESEARCH

BEST PRACTICES RESEARCH 2013 Frost & Sullivan 1 We Accelerate Growth Entrepreneurial Company of the Year Award Pharmaceutical Knowledge Process Outsourcing North America, 2013 Frost & Sullivan s Global Research Platform Frost

More information

Medical affairs Driving influence across the health care ecosystem

Medical affairs Driving influence across the health care ecosystem Medical affairs Driving influence across the health care ecosystem Introduction Biopharmaceutical companies are aggressively pursuing strategies to remain competitive by developing and marketing innovative

More information

Market Access Consulting

Market Access Consulting Market Access Consulting Table of contents 01 Optimize your drug development journey 02 Overcome your unique challenges 03 Transform your results 04 Unlock your value story 05 Solutions for your success

More information

Strategic Consulting Services

Strategic Consulting Services Services 1 Leadership Team Mark Levonyak President mlevonyak@davaonc.com Mobile: 214.460.5051 Martin W. Lee, MD EVP, Clinical Trial Services mlee@davaonc.com Mobile: 952.373.1405 John Eckardt, MD Chief

More information

An Introduction to Valuations

An Introduction to Valuations An Introduction to Valuations PREPARED FOR ROCKY MOUNTAIN BIOBOOSTER MAY 9 TH, 2012 An ICON plc Company Agenda Introductions Valuation methods When is a valuation appropriate? How do you maximize your

More information

IBM Learning Solutions Executive Brief. Learning strategy an investment in the future.

IBM Learning Solutions Executive Brief. Learning strategy an investment in the future. IBM Learning Solutions Executive Brief Learning strategy an investment in the future. September 2005 Page 2 Contents 2 Introduction 3 Do you need a learning strategy? 4 Current learning strategy insights

More information

through advances in risk-based

through advances in risk-based Insight brief Quintiles is a market leader with >100 risk-based monitoring studies Quintiles developed solutions that bring as much as 25% cost reduction over traditional trial execution approaches Transform

More information

HEALTH ECONOMICS AND OUTCOMES RESEARCH SERVICES

HEALTH ECONOMICS AND OUTCOMES RESEARCH SERVICES HEALTH ECONOMICS AND OUTCOMES RESEARCH SERVICES Health Economics and Outcomes Research cannot operate in a silo. An optimal value proposition requires strong and robust HEOR statements. We develop the

More information

Unlocking value across the payment continuum. Enhancing performance in a changing healthcare environment

Unlocking value across the payment continuum. Enhancing performance in a changing healthcare environment Unlocking value across the payment continuum Enhancing performance in a changing healthcare environment For payers, accuracy is business-critical The entire healthcare system is increasingly focused on

More information

MEDICAL DEVICE & DIAGNOSTICS

MEDICAL DEVICE & DIAGNOSTICS to Guide Strategic Medical Device and Introduction Medical device and diagnostic makers face myriad challenges when developing a new product, including working within resource and financial constraints,

More information

Technology and Expertise Add Operational Value to Medical Device Trials

Technology and Expertise Add Operational Value to Medical Device Trials Technology and Expertise Add Operational Value to Medical Device Trials Copyright 2015 Medidata Solutions. Medidata Solutions and other trademarks reserved in the US and globally. Medidata and other marks

More information

J.P. Morgan 2016 Healthcare Conference CEO. January 12, 2016 NYSE: Q. Copyright 2016 Quintiles

J.P. Morgan 2016 Healthcare Conference CEO. January 12, 2016 NYSE: Q. Copyright 2016 Quintiles J.P. Morgan 2016 Healthcare Conference Tom Pike CEO January 12, 2016 Copyright 2016 Quintiles NYSE: Q Forward Looking Statements and Use of Non-GAAP Financial Measures This presentation contains forward-looking

More information

Performance Profile. Clinical Study Physician. www.celyad.com 1

Performance Profile. Clinical Study Physician. www.celyad.com 1 Performance Profile Clinical Study Physician www.celyad.com 1 Role: Provide medical guidance and leadership throughout the development and conduct of clinical trials. You will be responsible for overseeing

More information

Strategy Planning Management Execution Analysis

Strategy Planning Management Execution Analysis Leading the way Strategy Planning Execution Analysis 1 Excellence in Delivery ICON is a division of ICON plc. It specializes in the planning management, execution, and analysis of Phase IIb IV clinical

More information

Managing the Product Record for the Medical Device Industry. Updated September 2007

Managing the Product Record for the Medical Device Industry. Updated September 2007 Managing the Product Record for the Medical Device Industry Updated September 2007 Managing the Product Record for the Medical Device Industry The dynamic medical device and instrumentation market depends

More information

2014 Wells Fargo Healthcare Conference June 17, 2014 NYSE: Q

2014 Wells Fargo Healthcare Conference June 17, 2014 NYSE: Q 2014 Wells Fargo Healthcare Conference June 17, 2014 NYSE: Q Copyright 2013 Quintiles Forward Looking Statements and Use of Non-GAAP Financial Measures This presentation contains forward-looking statements

More information

A Primer: Solving the Unique Problems of Orphan Drug Communications Programs

A Primer: Solving the Unique Problems of Orphan Drug Communications Programs A Primer: Solving the Unique Problems of Orphan Drug Communications Programs Introduction When communicating about orphan diseases and development of pharmaceuticals, it is essential to recognize the special

More information

MARKET ACCESS SERVICES. Managed Markets Services

MARKET ACCESS SERVICES. Managed Markets Services MARKET ACCESS SERVICES Managed Markets Services Table of contents 01 Your challenges 02 Your opportunities 03 Our services, your solutions 04 Advanced technology 05 Why Covance? 06 Get started... TOC 01

More information

The Evolving Comparative Analytics Market:

The Evolving Comparative Analytics Market: The Evolving Comparative Analytics Market: Benchmarking Key Business Metrics Against Peers to Reduce Risk, Pinpoint Areas for Improvement, and Optimize Performance March 2013 UNDERSTANDING THE OPPORTUNITY

More information

Access. Action. Insight. Healthcare Analytics and Marketing Communications Consultative, Analytical, and Promotional Solutions

Access. Action. Insight. Healthcare Analytics and Marketing Communications Consultative, Analytical, and Promotional Solutions Cardinal Health Specialty Solutions Healthcare Analytics and Marketing Communications Consultative, Analytical, and Promotional Solutions Access Action Insight In today s increasingly competitive healthcare

More information

BioPharma Analytics Informing every move

BioPharma Analytics Informing every move Specialty Solutions Insight Decisions Providers Payors Direction Patients BioPharma Analytics Informing every move Achieve market success faster with evidence-based market intelligence Cardinal Health

More information

Perceptive MyTrials Product Overview

Perceptive MyTrials Product Overview Perceptive MyTrials The suite is greater than the sum of its parts. SINGLE SIGN ON CTMS EDC & Designer Medical Imaging RTSM Metrics & Reports Regulatory Information Management Collaboration epro Data-Driven

More information

Welcome to today s training on how to Effectively Sell SAP ERP! In this training, you will learn how SAP ERP addresses market trends and

Welcome to today s training on how to Effectively Sell SAP ERP! In this training, you will learn how SAP ERP addresses market trends and Welcome to today s training on how to Effectively Sell SAP ERP! In this training, you will learn how SAP ERP addresses market trends and organizations business needs. 1 After completing this lesson, you

More information

GLOBAL CORPORATE SERVICES

GLOBAL CORPORATE SERVICES GLOBAL CORPORATE SERVICES ALIGNING CBRE s Global Corporate Services (GCS) is the world leader in commercial real estate services. As the top real estate services provider named to the Global Outsourcing

More information

The Cell Therapy Catapult

The Cell Therapy Catapult The Cell Therapy Catapult Keith Thompson CEO January 29 2013 info@ct.catapult.org.uk Catapult is a Technology Strategy Board programme The Launch of Catapults Hauser 2 Hauser Report Creating new manufacturing

More information

LARGE SCALE NETWORKS NEXT WAVE OF CLINICAL INTEGRATION

LARGE SCALE NETWORKS NEXT WAVE OF CLINICAL INTEGRATION CENTER FOR INDUSTRY TRANSFORMATION MAY 2015 LARGE SCALE NETWORKS NEXT WAVE OF CLINICAL INTEGRATION Authors Michael Strilesky Principal, DHG Healthcare michael.strilesky@dhgllp.com DHG HEALTHCARE CENTER

More information

Driving Healthcare Efficiency through Transformational Sourcing. www.avasant.com

Driving Healthcare Efficiency through Transformational Sourcing. www.avasant.com Driving Healthcare Efficiency through Transformational Sourcing www.avasant.com Reshaping of the U.S. Health eco-system The signing of the Patient Protection and Affordable Care Act (ACA) into law in 2010

More information

What We Are..! www.ardent-cro.com

What We Are..! www.ardent-cro.com Your Trusted CRO! Regus, Level-2, Connaught Place, Bund Garden Road, Pune-411001, MH, India. Phone: 020-65-31-31-71 Email: ardent@ardent-cro.com Web: What We Are..! Ardent Clinical Research Services is

More information

I D C M a r k e t S c a p e : W o r l d w i d e F i n a n c i a l S e r v i c e s C o n s u l t i n g 2 0 1 2 V e n d o r A n a l y s i s

I D C M a r k e t S c a p e : W o r l d w i d e F i n a n c i a l S e r v i c e s C o n s u l t i n g 2 0 1 2 V e n d o r A n a l y s i s Global Headquarters: 5 Speen Street Framingham, MA 01701 USA P.508.872.8200 F.508.935.4015 www.idc.com C O M P E T I T I V E A N A L Y S I S I D C M a r k e t S c a p e : W o r l d w i d e F i n a n c

More information

Richard T. Clark Chief Executive Officer and President. Executing on Our Strategy

Richard T. Clark Chief Executive Officer and President. Executing on Our Strategy Richard T. Clark Chief Executive Officer and President Executing on Our Strategy Merck s Plan to Win: Preparing for Our Future Success BECOME THE MOST TRUSTED INDUSTRY LEADER IN DELIVERING VALUE TO CUSTOMERS

More information

Cloud Marketing: Faces in the Cloud

Cloud Marketing: Faces in the Cloud Robert Groebel September 25, 2015 Features Cloud Marketing: Faces in the Cloud Share this article: facebook twitter linkedin google Comments Email Print As the need for more informed conversations with

More information

TRANSFORMING DATA MANAGEMENT WITH THE USE OF AN INTEGRATED TECHNOLOGY SUITE

TRANSFORMING DATA MANAGEMENT WITH THE USE OF AN INTEGRATED TECHNOLOGY SUITE CASE STUDY 0 PAREXEL INFORMATICS AND ALMIRALL TRANSFORMING DATA MANAGEMENT WITH THE USE OF AN INTEGRATED TECHNOLOGY SUITE Situation Almirall R&D Sant Feliu top priorities are safeguarding the health of

More information

Chart Optimize Transform Your Data Center

Chart Optimize Transform Your Data Center Chart Optimize Transform Your Data Center Advisory Services The Strength of Your Network Begins with An Optimized Physical Infrastructure The performance of your data center depends on a complex interrelationship

More information

RAPS ONLINE UNIVERSITY

RAPS ONLINE UNIVERSITY RAPS ONLINE UNIVERSITY Practical education and training for business success. For regulatory professionals, there is only one name to know and trust for online education and training RAPS Online University.

More information

In-House Executive Search

In-House Executive Search In-House Executive Search Changing The Senior Leadership Recruiting Game In-house Executive Search Will it be a game changer in executive search? Explore why companies are building internal capability

More information

U.S. Food and Drug Administration Center for Devices and Radiological Health REGULATORY SCIENCE PRIORITIES (FY2016)

U.S. Food and Drug Administration Center for Devices and Radiological Health REGULATORY SCIENCE PRIORITIES (FY2016) U.S. Food and Drug Administration Center for Devices and Radiological Health REGULATORY SCIENCE PRIORITIES (FY2016) Executive Summary October 20, 2015 The Regulatory Science Subcommittee (RSS) of the CDRH

More information

Waife & Associates, Inc. Change Management for Clinical Research

Waife & Associates, Inc. Change Management for Clinical Research Waife & Associates, Inc. Change Management for Clinical Research There is a light through the fog We help biopharmaceutical companies build global competitive advantage in their clinical research operations.

More information

Guidance for Industry. Q10 Pharmaceutical Quality System

Guidance for Industry. Q10 Pharmaceutical Quality System Guidance for Industry Q10 Pharmaceutical Quality System U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation

More information

Planning for Successful Medical Device Reimbursement:

Planning for Successful Medical Device Reimbursement: Planning for Successful Medical Device Reimbursement: So Your Device Is Cleared, By Tiffini Diage, MPH Health Economics NAMSA White Paper Key Considerations for Targeting Success of Medical Device Sales

More information

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH

Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH Manufacturing CUSTOM CHEMICALS AND SERVICES, SUPPORTING SCIENTIFIC ADVANCES FOR HUMAN HEALTH VWR enables the advancement of science by providing high-quality chemicals and services, customized to your

More information

Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset

Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset Taking Strategic Partnerships to the Next Level: An Alternative Approach to Licensing Your Development Asset Introduction In this era of strategic development deals, inventiv Health has significantly broadened

More information

July 2015. New Entrants: Charting the Health Industry s Risk and Regulatory Landscape Where Risk Meets Opportunity

July 2015. New Entrants: Charting the Health Industry s Risk and Regulatory Landscape Where Risk Meets Opportunity July 2015 New Entrants: Charting the Health Industry s Risk and Regulatory Landscape Where Risk Meets Opportunity The new health economy is bringing change and new entrants from diverse industries are

More information

Peirce College. Summary of 2015-2018 Strategic Plan

Peirce College. Summary of 2015-2018 Strategic Plan Peirce College Summary of 2015-2018 Strategic Plan Contents Strategic Planning Process Vision and Mission Target Market Value Proposition Summary of Strategic Initiatives Timeline and Implementation Strategic

More information

Quality by Design Concept

Quality by Design Concept 3rd Jerusalem Conference on Quality and Pharma Sciences 6-7 June, 2012 QbD in Clinical Research - Where Can QbD Impact Clinical Research Practices? Dr. Yafit Stark Vice President, TEVA Pharmaceutical Industries,

More information

Clinical Trials: The Crux of Cancer Innovation

Clinical Trials: The Crux of Cancer Innovation Clinical Trials: The Crux of Cancer Innovation Even as medical science is transforming cancer care, major deficiencies in the way cancer clinical trials are designed, carried out, regulated and funded

More information

Electronic data interchange and proactive services for Centricity revenue cycle management customers

Electronic data interchange and proactive services for Centricity revenue cycle management customers GE Healthcare Electronic data interchange and proactive services for Centricity revenue cycle management customers Accelerate revenue perf Key features Tight alignment with payers ensures mandates, updates

More information

Shaping the Future of Healthcare

Shaping the Future of Healthcare Shaping the Future of Healthcare www.imsconsultinggroup.com Join a team of people who are committed to advancing healthcare IMS Consulting Group (IMSCG) is the leading global management consulting firm

More information

A more efficient approach to regulatory maintenance of marketed products

A more efficient approach to regulatory maintenance of marketed products White paper The Hub & Spoke model: A more efficient approach to regulatory maintenance of marketed products Redeploy regulatory assets to profit drivers Peter Lassoff, PharmD, Vice President and Head of

More information

GSK in Singapore. More than 40 years of partnership in Asia

GSK in Singapore. More than 40 years of partnership in Asia GSK in Singapore More than 40 years of partnership in Asia From a single antibiotic plant in 1972, GSK now has extensive activities in Singapore spanning manufacturing to commercial operations. Today this

More information

Software Development for Medical Devices

Software Development for Medical Devices Overcoming the Challenges of Compliance, Quality and Cost An MKS White Paper Introduction Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software

More information

HOT TOPICS IN IN HEALTH CARE REFORM

HOT TOPICS IN IN HEALTH CARE REFORM By Felicia Fuller Publications Manager, DAC Patient Recruitment Services The Patient Protection and Affordable Care Act (ACA), colloquially known as Obamacare, is in full effect and its impact is palpable

More information

GE Healthcare. Electronic data interchange and proactive services for Centricity revenue cycle management customers

GE Healthcare. Electronic data interchange and proactive services for Centricity revenue cycle management customers GE Healthcare Electronic data interchange and proactive services for Centricity revenue cycle management customers Accelerate revenue perf Key features updates and other payer-specific adjustments are

More information

Key considerations for outsourcing late phase clinical research

Key considerations for outsourcing late phase clinical research Key considerations for outsourcing late phase clinical research Alan Nelson (on behalf of Van Zyl Engelbrecht) Senior Project Director at UBC: An Express Script Company Layout of presentation My presentation

More information

EU Clinical Trials Regulation Regulation EU 536/2014

EU Clinical Trials Regulation Regulation EU 536/2014 EU Clinical Trials Regulation Regulation EU 536/2014 María Jesús Zafra Director, QA & Compliance Table of contents 1 2 3 4 Introduction Timelines and main changes Highlights 5 Impact on company processes

More information

Healthcare Internal Audit: In a Time of Transition

Healthcare Internal Audit: In a Time of Transition The 2015 State of the Internal Audit Profession Study Healthcare Internal Audit: In a Time of Transition The healthcare industry in the United States is facing many challenges with the enactment of legislation

More information

Electronic data interchange and proactive services for customers using revenue cycle management solutions from the Centricity portfolio

Electronic data interchange and proactive services for customers using revenue cycle management solutions from the Centricity portfolio GE Healthcare Electronic data interchange and proactive services for customers using revenue cycle management solutions from the Centricity portfolio imagination at work Accelerate revenue cycle performance

More information

BUSINESS CONSULTING SERVICES Comprehensive practice management solutions for independent investment advisors

BUSINESS CONSULTING SERVICES Comprehensive practice management solutions for independent investment advisors BUSINESS CONSULTING SERVICES Comprehensive practice management solutions for independent investment advisors Insights, tools and resources to help you Accelerate Your Growth, Scale Your Business and Elevate

More information

We design talent strategies that accelerate business outcomes.

We design talent strategies that accelerate business outcomes. 1 We design talent strategies that accelerate business outcomes. Where there are critical gaps, we build talent from within and attract new talent from the outside. At every level of the enterprise, we

More information

CGI Payments360. Moving money with greater agility and confidence. Experience the commitment

CGI Payments360. Moving money with greater agility and confidence. Experience the commitment CGI Payments360 Moving money with greater agility and confidence Experience the commitment Addressing today s payments realities Customers want the ability to buy anything, pay anyone and bank anywhere

More information

February 2014 Patient Savings Program Use Analysis

February 2014 Patient Savings Program Use Analysis Providing key policy setters and decision makers in the global health sector with unique and transformational insights into healthcare dynamics derived from granular analysis of information. February 2014

More information

2011-2016 Strategic Plan. Creating a healthier world through bold innovation

2011-2016 Strategic Plan. Creating a healthier world through bold innovation 2011-2016 Strategic Plan Creating a healthier world through bold innovation 2011-2016 STRATEGIC PLAN Table of contents I. Global direction 1 Mission and vision statements 2 Guiding principles 3 Organizational

More information

Is it time for a new drug development paradigm?

Is it time for a new drug development paradigm? Is it time for a new drug development paradigm? Robert McDonough, M.D. Senior Director, Clinical Policy Research and Development 1 The Aetna Way Our Cause To make quality health care more affordable and

More information

Regulatory Affairs Professional Development Framework AN OVERVIEW

Regulatory Affairs Professional Development Framework AN OVERVIEW Regulatory Affairs Professional Development Framework AN OVERVIEW TABLE OF CONTENTS Abstract...2 Introduction...2 Approach...3 Professional Development Framework...3 Professional Levels...3 Domains...4

More information

Revenue Cycle Management: What s Next in Healthcare

Revenue Cycle Management: What s Next in Healthcare Revenue Cycle Management: What s Next in Healthcare FEBRUARY 2014 Table of Contents Introduction... 3 Background... 3 Study Design... 3 Common Overall Business Priorities... 4 Management Priorities...

More information

At the Heart of Virtualizing Insurance

At the Heart of Virtualizing Insurance At the Heart of Virtualizing Insurance New Era in Property and Casualty (P&C) Insurance Cloud Computing Strategic Implementation of Cloud Computing Services Adds Effectiveness and Efficiency to the Insurance

More information

Engineering for the new pharma reality

Engineering for the new pharma reality NNE Pharmaplan is an international company specialised in pharma engineering. We help pharmaceutical companies bring products to market by providing flexible, compliant and future-proof solutions. We have

More information

FDA Tobacco Regulatory Science Fellowship

FDA Tobacco Regulatory Science Fellowship FDA Tobacco Regulatory Science Fellowship Program Overview FDA Tobacco Regulatory Science Fellowship Launched in 2012, this regulatory science fellowship is a collaborative program between the FDA Center

More information

Financial Services Internal Audit Increased expectations of value

Financial Services Internal Audit Increased expectations of value Financial Services Internal Audit Increased expectations of value The critical issues financial institutions face today are affecting their entire business. The industry continues to face regulatory reform

More information

Transform HR into a Best-Run Business Best People and Talent: Gain a Trusted Partner in the Business Transformation Services Group

Transform HR into a Best-Run Business Best People and Talent: Gain a Trusted Partner in the Business Transformation Services Group SAP Services Transform HR into a Best-Run Business Best People and Talent: Gain a Trusted Partner in the Business Transformation Services Group A Journey Toward Optimum Results The Three Layers of HR Transformation

More information

Managing and Integrating Clinical Trial Data: A Challenge for Pharma and their CRO Partners

Managing and Integrating Clinical Trial Data: A Challenge for Pharma and their CRO Partners Managing and Integrating Clinical Trial Data: A Challenge for Pharma and their CRO Partners Within the Pharmaceutical Industry, nothing is more fundamental to business success than bringing drugs and medical

More information

CSR / Sustainability Governance and Management Assessment By Coro Strandberg Principal, Strandberg Consulting www.corostrandberg.

CSR / Sustainability Governance and Management Assessment By Coro Strandberg Principal, Strandberg Consulting www.corostrandberg. Introduction CSR / Sustainability Governance and Management Assessment By Coro Strandberg Principal, Strandberg Consulting www.corostrandberg.com June 2015 Companies which adopt CSR or sustainability 1

More information

SAP BusinessObjects. Solutions for Large Enterprises & SME s

SAP BusinessObjects. Solutions for Large Enterprises & SME s SAP BusinessObjects Solutions for Large Enterprises & SME s Since 1993, we have been using our BI experience to ensure you buy the right licences at the lowest price, thus helping to deliver the best and

More information

Internal audit strategic planning Making internal audit s vision a reality during a period of rapid transformation

Internal audit strategic planning Making internal audit s vision a reality during a period of rapid transformation 2015 State of the Internal Audit Profession Study Internal audit strategic planning Making internal audit s vision a reality during a period of rapid transformation 68% of companies have gone through or

More information

Solutions For. Information, Insights, and Analysis to Help Manage Business Challenges

Solutions For. Information, Insights, and Analysis to Help Manage Business Challenges Solutions For Health Plans Information, Insights, and Analysis to Help Manage Business Challenges Solutions for Health Plans Health plans are challenged with controlling medical costs, engaging members

More information

Optum TM Consumer Acquisition Platform. A Next-Generation Approach to Acquire, Retain and Engage Members.

Optum TM Consumer Acquisition Platform. A Next-Generation Approach to Acquire, Retain and Engage Members. Optum TM Consumer Acquisition Platform A Next-Generation Approach to Acquire, Retain and Engage Members. Challenge and opportunity have arrived at the same time for health plans. Millions of consumers

More information

Adopting a Continuous Integration / Continuous Delivery Model to Improve Software Delivery

Adopting a Continuous Integration / Continuous Delivery Model to Improve Software Delivery Customer Success Stories TEKsystems Global Services Adopting a Continuous Integration / Continuous Delivery Model to Improve Software Delivery COMMUNICATIONS AGILE TRANSFORMATION SERVICES Executive Summary

More information

American College of Medical Genetics and Genomics Strategic Plan

American College of Medical Genetics and Genomics Strategic Plan American College of Medical Genetics and Genomics Strategic Plan The American College of Medical Genetics and Genomics (ACMG) is the specialty society for diplomates certified by the American Board of

More information

ACCOUNTABLE CARE ANALYTICS: DEVELOPING A TRUSTED 360 DEGREE VIEW OF THE PATIENT

ACCOUNTABLE CARE ANALYTICS: DEVELOPING A TRUSTED 360 DEGREE VIEW OF THE PATIENT ACCOUNTABLE CARE ANALYTICS: DEVELOPING A TRUSTED 360 DEGREE VIEW OF THE PATIENT Accountable Care Analytics: Developing a Trusted 360 Degree View of the Patient Introduction Recent federal regulations have

More information

How to stay competitive in a converging healthcare system kpmg.com

How to stay competitive in a converging healthcare system kpmg.com Managing risk in a transforming healthcare organization How to stay competitive in a converging healthcare system kpmg.com 2 Healthcare Risk Management Managing the risk of healthcare transformation Healthcare

More information

A Roadmap to Clinical Integration: How to Successfully Transition to Value, While Still Operating in the Fee-for-Service World

A Roadmap to Clinical Integration: How to Successfully Transition to Value, While Still Operating in the Fee-for-Service World A Roadmap to Clinical Integration: How to Successfully Transition to Value, While Still Operating in the Fee-for-Service World In healthcare, transitions of care from one practice setting to another can

More information

Global Headquarters: 5 Speen Street Framingham, MA 01701 USA P.508.872.8200 F.508.935.4015 www.idc.com

Global Headquarters: 5 Speen Street Framingham, MA 01701 USA P.508.872.8200 F.508.935.4015 www.idc.com Global Headquarters: 5 Speen Street Framingham, MA 01701 USA P.508.872.8200 F.508.935.4015 www.idc.com E X C E R P T I D C M a r k e t S c a p e : U. S. B u s i n e s s C o n s u l t i n g S e r v i c

More information

Agile Master Data Management TM : Data Governance in Action. A whitepaper by First San Francisco Partners

Agile Master Data Management TM : Data Governance in Action. A whitepaper by First San Francisco Partners Agile Master Data Management TM : Data Governance in Action A whitepaper by First San Francisco Partners First San Francisco Partners Whitepaper Executive Summary What do data management, master data management,

More information

shutterstock.com Interim Management and Strategic Transactions for International Life Science Companies TCG: experienced, connected, proven success

shutterstock.com Interim Management and Strategic Transactions for International Life Science Companies TCG: experienced, connected, proven success shutterstock.com Interim Management and Strategic Transactions for International Life Science Companies TCG: experienced, connected, proven success Proven success and contacts. Not just talk. TCG is a

More information

CDISC Strategy Document Version 9 (Final BOD Approved Version) 4 December 2006

CDISC Strategy Document Version 9 (Final BOD Approved Version) 4 December 2006 CDISC Strategy Document Version 9 (Final BOD Approved Version) 4 December 2006 Introduction The Clinical Data Interchange Standards Consortium (CDISC) has established standards to support the acquisition,

More information

Business Agility SURVIVAL GUIDE

Business Agility SURVIVAL GUIDE Business Agility SURVIVAL GUIDE 1 Every industry is subject to disruption. Only a truly agile business is equipped to respond.* Agile firms grow revenue 37% faster. Agile firms generate 30% higher profits.**

More information

Organization transformation in times of change

Organization transformation in times of change Organization transformation in times of change Insurance is sold, not bought is a phrase of unknown attribution, but common wisdom for decades. Thus, insurers and most financial services organizations

More information

The Rising Tide of Pharmacy Benefit Cost and Complexity: A health plans roadmap to optimizing pharmacy services relationships

The Rising Tide of Pharmacy Benefit Cost and Complexity: A health plans roadmap to optimizing pharmacy services relationships The Rising Tide of Pharmacy Benefit Cost and Complexity: A health plans roadmap to optimizing pharmacy services relationships New pharmacy benefit challenges After several years of manageable pharmacy

More information

Accelerating the Clinical Development Journey with Improved

Accelerating the Clinical Development Journey with Improved white paper Accelerating the Clinical Development Journey with Improved Data Management How eclinical systems can break the data fragmentation barrier The need to improve data management and analysis,

More information

Business ByDesign. The SAP Business ByDesign solution helps you optimize project management

Business ByDesign. The SAP Business ByDesign solution helps you optimize project management SAP Functions in Detail SAP Solutions for Small Businesses and Midsize Companies Efficient Project Management Drive Project Success with SAP Business ByDesign The SAP Business ByDesign solution helps you

More information

Oncology s $5 Billion Opportunity: Oncology Companies Can Improve the Customer Experience

Oncology s $5 Billion Opportunity: Oncology Companies Can Improve the Customer Experience Oncology s $5 Billion Opportunity: Oncology Companies Can Improve the Customer Experience The 2015 ZS Oncology Customer Experience Tracker Jon Roffman, Sankalp Sethi and Pranav Srivastava Oncology s $5

More information

Talent & Organization. Change Management. Driving successful change and creating a more agile organization

Talent & Organization. Change Management. Driving successful change and creating a more agile organization Talent & Organization Change Management Driving successful change and creating a more agile organization 2 Organizations in both the private and public sectors face unprecedented challenges in today s

More information

Onboarding. Design Build Attract

Onboarding. Design Build Attract Onboarding Design Build Attract The most critical time in an executive s career is the first 100 days in a new role. Executives promoted or hired into new roles are expected to not only find their way,

More information

IDC MarketScape: Asia/Pacific Business Consulting Services 2015 Vendor Assessment

IDC MarketScape: Asia/Pacific Business Consulting Services 2015 Vendor Assessment IDC MarketScape IDC MarketScape: Asia/Pacific Business Consulting Services 2015 Vendor Assessment Cushing Anderson Mayur Sahni Takuya Uemura THIS IDC MARKETSCAPE EXCERPT FEATURES PWC IDC MARKETSCAPE FIGURE

More information