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Advisory Services

Transforming biopharma to accelerate the development and commercialization of innovative therapies for patients worldwide


Our Approach

Quintiles Advisory Services, the consulting arm of Quintiles, is a different kind of healthcare advisory group – built on a blend of deep industry and therapeutic expertise, strategic problem-solving skills and rich data assets.

We bring a broad understanding of end-to-end drug development and healthcare delivery to help firms develop the strategies and capabilities needed to develop and launch products with the greatest potential for commercial success and patient outcomes, based on the right evidence needed to demonstrate value.

Quintiles Advisory Services is built on focus, knowledge and an understanding of healthcare.

Strategic problem-solving and evidence generation
Industry-leading perspectives
  • Our team of seasoned management consultants draw upon their extensive advisory services experience and focus on accelerating superior outcomes guided by connected insights, strategic thinking and actionable solutions.
Domain expertise with scale and reach
Global footprint and scale
  • Quintiles Advisory Services brings deep expertise across multiple domains and harnesses the power of hybrid teams including our 1,100 medical doctors and more than 1,050 PhDs across our global organization, with over 30 years of clinical research and commercial experience ability to serve approximately 100 countries help to bring actionable insights and solutions.
Rich data integration
Innovative technology
  • Through the strength of our extensive data and analytical engines, we provide evidence to develop strategic approaches to asset development, and implementation plans, and the delivery of high quality, integrated global solutions.
Strategy to operations
Advise-create-operate
  • We offer strategic advice which can lead to fulfilling operational partnerships with Quintiles, from outsourcing of clinical development and mature products to joint operations of functions throughout the value chain.

We operate on the principle that the best evidence is based on connected, broad insight which results in actionable solutions, faster implementation and ultimately superior outcomes/value

Solutions

Our ability to leverage the broader operational capabilities across the global Quintiles organization, allows us to also bring perspectives and solutions developed through real-world experience across the value chain.

advisory services icon market intelligence and market planning
Market Intelligence & Market Planning
Use advanced primary research methodologies and decision modelling to generate unique market insights and build plans for clinical and commercial development throughout the product life cycle.
advisory services icon enterprise quality management and compliance
Enterprise Quality Management & Compliance
Support clients in all aspects of proactive and reactive global quality and regulatory compliance, including, developing regulatory strategies, conducting compliance audits & gap analyses, vendor audits and preparing responses to FDA 483 citations and warning letters.
advisory services icon technical and commercial due diligence
Technical & Commercial Due Diligence
Help biopharma clients decide whether to develop or acquire assets tailored to the portfolio, therapeutic area/disease or asset level using real-world data and technical probability analysis.
advisory services icon value and outcomes strategy
Value & Outcomes Strategy
Help biopharma companies design, develop and execute evidence plans that clearly articulate and support the value story for a product or device with rigorous, compelling data targeted to key healthcare system stakeholders including health economics and outcomes research, patient-centered endpoints, market access and policy analysis.
advisory services icon integrated asset development planning
Integrated Asset Development Planning
Deliver key asset planning components required for successful asset development and commercialization including the target product profile, clinical development plan, market access plan, launch plan and commercialization.
advisory services icon mature product management
Mature Product Management
Help pharmaceutical companies consider alternatives for creating value from their mature products, including sales and marketing promotion and divestment. Quintiles also offers outsourcing capabilities to develop and implement programs aimed at capturing incremental value.
advisory services icon clinical development transformation
Clinical Development Transformation
Leverage novel approaches for clinical trial design and execution that improve the probability of commercial success and maximize return on investment for products in development.
advisory services icon innovative launch strategy
Innovative Launch Strategy
Provide asset and market-tailored launch strategy and support which take into account local market variability, evidence expectations, higher standards for market access, new channels and stakeholders.
advisory services icon regulatory and safety optimization
Regulatory & Safety Optimization
Help companies assess and optimize the value, approach and key activities required to manage their regulatory, safety and benefit risk management (BRM) capabilities, including virtualization.
advisory services icon end to end partnerships
End-to-end Partnerships
Design and execute custom strategic partnership models for biopharma companies including providing the bench strength or outsourcing capabilities across the product life cycle, from strategy and early phase to post-authorization and commercial.
Asset Evaluation & Due Diligence   +

Using a combination of analytical tools, scientific expertise, strategic thinking and operational experience, Quintiles Advisory Services helps biopharma clients decide whether to develop or acquire assets (organic, inorganic, early or late stage) tailored to the portfolio, therapeutic area/disease or asset level. This approach considers the technical probability of success; development and commercial uncertainties; and real-world patient segmentation analyses – which allows us to conduct mock HTA assessments and offer development strategy alternatives.
Integrated Asset Development Plan   +

optimizing valueintegrated asset development

Quintiles Advisory Services’ end-to-end, cross functional approach brings together clinical, commercial and regulatory insight encompassing all phases of product development. We focus on helping you achieve faster market access and sustained commercial success. The approach integrates key planning components including the target product profile, clinical development plan, market access plan, launch plan and commercialization required for successful asset development and commercialization. While this solution focuses on a portfolio of assets, it differs from our End-to-end Planning, which focuses on the organization and outsourcing key aspects of it for operational efficiencies.

  
Clinical Transformation Strategies   +

Designed to improve the probability of market success in a complex healthcare ecosystem, this holistic approach to drug development focuses on designing and managing trials with commercial implications in mind and generating compelling evidence across diverse stakeholders. Quintiles Advisory Services helps improve clinical development effectiveness by deploying innovative scientific approaches that target patients’ unmet medical needs – and by focusing on the optimal data necessary for planning, designing and executing clinical trials. We also help improve operational efficiencies with effective operating and governance models that apply a holistic, experience-based performance management framework.
Regulatory & Safety Virtualization   +

Quintiles Advisory Services’ regulatory and safety experts assess your organization, operations and technology. We facilitate alignment between your regulatory and safety business model and your company’s strategic business and growth objectives. We use an extensive toolkit of continuously updated, industry-leading benchmarks and practices to improve your people, processes and tools – or determine your best path forward – for strategic partnering.
Value & Outcomes Evidence Optimization   +

Quintiles Advisory Services helps biopharma companies design, develop and execute evidence plans that clearly articulate and support the value story for a product or device with rigorous, compelling data targeted to key healthcare system stakeholders (e.g., regulators, payers, providers, patients). We leverage internal centers of excellence across a wide array of scientific areas (e.g. personalized medicine, rare diseases, biosimilars) and robust in-house data sources including clinical trial data, health insurance claims, and electronic medical records, to generate the real-world evidence necessary to maximize marketplace success. Our advisory expertise is deep in the domains of health economics, epidemiology, population health management, market access, policy analysis, and patient-centered endpoints.

Launch of the Future   +

To meet the needs of a changing marketplace, biopharma companies must think creatively about their value proposition and how well it provides customer value in terms of clinical outcomes and population cost. Quintiles Advisory Services’ clinical development expertise and global market knowledge helps you define the right value proposition for marketplace success and build the right capabilities to serve the markets in which you operate. Our approach prioritizes payer and patient models appropriate to the evolving needs of the marketplace, and is analytically rigorous, comprehensive and customized to each disease area and the client’s commercial objectives.
Mature Product & Outsourcing Strategies   +

Quintiles Advisory Services advises biopharma companies looking to improve revenue, reduce operational expenses and/or enhance their market position through effective management of mature products or outsourcing identified aspects of your business. We help you free up internal resources to focus on more profitable products by developing a plan to outsource aspects of the business while maintaining efficiency and expert management. Our collaborative model connects biopharma clients with strategic and operational experts who provide unparalleled local and global experience. For mid- and large-size biopharma, we provide integrated, multi-channel engagement services that combine diverse field-based roles and effective digital approaches to drive productivity and allow deployment of new commercial models at reduced risk. For established / emerging specialty pharma and biotech companies with limited commercial infrastructure, we provide a holistic “virtual pharma” solution that helps maximize and retain the value of their assets – and deliver successful brand launches.
End-to-end Partnerships   +

Quintiles Advisory Services designs and executes custom strategic partnership models for biopharma companies. We offer this expertise across the product life cycle, from strategy and early phase to post-authorization and commercial. Whether looking for help in designing a protocol, to gaining market access or outsourcing an entire clinical development organization, our team is equipped to develop the strategy and tactics for meeting your business goals. The approach includes providing the bench strength for operationalizing the plan over extended periods of time as our biopharma partners stand up their own operating infrastructure. This allows our partners to focus resources in order to expand the pipeline; increase productivity by reducing costs and timelines while improving quality; increase predictability of forecasts and budgets; and improve their probability of success. While this solution focuses on the organization – and outsourcing key aspects of it for operational efficiencies – it differs from our Integrated Asset Develop Plan (IADP) solution, which focuses on optimizing a portfolio of assets for faster market access and sustained commercial success.

Quality & Compliance   +

Quintiles Advisory Services helps you with all aspects of global quality and regulatory compliance, including developing regulatory strategies, conducting compliance audits and gap analyses, conducting mock inspections, ensuring good clinical, laboratory and manufacturing practices, and preparing responses to FDA 483 citations and warning letters. Our approach ultimately transforms and enhances business operations by integrating key components including the analysis and auditing of current operations, developing a proactive quality and compliance strategy, as well as creating corrective and preventative action plans (CAPA). We also tailor quality training programs and support organizational change management in order to drive overall compliance sustainability.

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