Quintiles Library

Having worked with more than 240 small and emerging biopharma companies in more than 500 trials since 2009, our new model is designed to deliver our global experience and capabilities with the dedication you desire.
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Press Release
Agreement to merge with IMS Health in all-stock transaction to create Quintiles IMS, an industry-leading information and technology-enabled healthcare services provider 8.4% constant currency service revenue growth compared to the first quarter of 2015 $0.89 diluted adjusted EPS representing 23.6% growth compared to the first quarter of 2015 Net new business of $1.03 billion in the first quarter of 2016, representing a 0.93 book-to-bill and resulting in backlog of $12 billion as of March 31, 2016 Cash flow from operations of $112.1 million and free cash flow of $85.9 million in the three months ended March 31, 2016 Reaffirming full year 2016 service revenue constant currency growth guidance of 7.0% to 8.5% compared to full year 2015 and diluted adjusted EPS...
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White Paper
Biopharma companies face significant complexity working in a global environment governed by rigorous regulatory and safety requirements that vary by market. To effectively manage your portfolio, you need to do more than simply meet regulatory requirements. By aligning all aspects of marketed product maintenance, including regulatory, safety and benefit-risk management, you can improve compliance, and reduce complexity and...
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Fact Sheet
Healthcare systems are transforming from volume to value to outcomes. This shift fundamentally changes the way that biopharmaceutical companies approach drug development. The Quintiles Value & Outcomes Strategy Solution helps clients develop the evidence base to define the clinical, economic and humanistic profile of products. These are tailored to stakeholders’ needs to help improve their probability of success and healthcare system...
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Fact Sheet
As the demands of clinical development change, being nimble and adaptable becomes more critical. Meeting the evolving needs of multiple stakeholders ultimately determines the probability of success. And new agile development models are required to meet customer needs and increasing competitive intensity. Innovative technologies allow pharma companies to explore and pursue patient-centric approaches to trial execution and data collection in ways that were previously...
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Press Release
RESEARCH TRIANGLE PARK, N.C. – April 22, 2016 – Quintiles, the world’s leading provider of biopharmaceutical services, announced today that it has been named to the 2016 CSO50 by IDG's CSO magazine. This award recognizes the company’s innovative identity management solution designed to expedite activities related to the delivery of clinical trials while simultaneously protecting confidential user data. This is the company’s fourth consecutive year receiving the prestigious security award. Quintiles’ Identity Management Solution introduced identity vetting, identity storage and identity synchronization that improved data quality for both existing and newly established users. The resulting system supports faster business enablement of critical project activities including site start-up...
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Presentation
Observational research is increasingly recognized as an important source of evidence for healthcare decision-making. Regulators, payers and providers assess observational study quality, and the International Society for Epidemiology provides Guidelines for Good Pharmacoepidemiology Practices (GPP). However, many studies are failing to meet required standards for design, operations and analysis, so limiting their value to decision-makers. Determining the right approach to achieve observational study research objectives and then operationalizing it requires education, training, experience and specialized approaches. Large or small, every study is different and calls for its own operational strategy to fulfill its unique objectives. During this webinar our experts Louise Parmenter, Global...
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Fact Sheet
One of the major challenges in Product Development involves identifying focused, hard-to-find patient populations. With Quintiles Precision Enrollment, sites are designed to start up within 21 days, offering the right trials to the right patients in a streamlined manner. Finding patients as quickly as possible is key to managing the cost and time pressures associated with clinical trials. Learn how to find the right sites and the right patients within 21 days. Contact us...
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Article
Observational research-evaluating outcomes in patients in a naturalistic rather than an experimental setting-has the potential to answer many research questions. But in order to do so effectively, researchers must select "the right research approach for the right question." Doing so requires thorough evaluation of feasibility of delivery, specialized operational approaches with an understanding of pitfalls to avoid, and an upfront plan to communicate the results to stakeholders for whom the results are...
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Article
Integrate Channels to Unleash Better Outcomes Multichannel is no longer an industry buzz word, rather, it’s a methodology for success amidst a tangled marketplace. Like the links of a chain, an integrated multichannel strategy connects channels, content, and customers in a straight line aimed directly at helping patients. The industry has moved reluctantly beyond face-to-face meetings as its only customer interface, and now looks to other channels to deliver its message. Virtual rep calls via the Internet, e-details delivering requested content or promotional compliant materials such as coupons and vouchers, visits to web sites, or conferences are just some of the viable and effective touchpoints. By making a few critical changes, life-sciences companies can intelligently leverage...
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Press Release
RESEARCH TRIANGLE PARK, N.C. – April 18, 2016 – Quintiles Transnational Holdings Inc. (NYSE: Q) will release its first quarter 2016 financial results Tuesday, May 3, 2016 prior to its quarterly earnings call at 8:00 a.m. EDT. The conference call will be accessible, live via webcast, on the Investor Relations section of the Quintiles website at www.quintiles.com/investors. To participate via telephone, please dial +1 (855) 710-5091 in the United States or +1 (706) 902-0591 outside the United States, approximately 15 minutes before the scheduled start of the call. An archived edition of the conference call will be available online at www.quintiles.com/investors after 1:00 p.m. EDT on Tuesday, May 3rd. About Quintiles Quintiles (NYSE: Q) helps biopharma and other healthcare companies...
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Article
Posted with permission from RAPS Regulatory Focus.   KT, Chew and Meenakshi, R. “Drug Development in Asia: Scattering the Mist.” Regulatory Focus. February 2016. Regulatory Affairs Professionals...
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Brochure
Quintiles medical device clinical...
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Article
Posted with permission from RAPS Regulatory Focus.   Chew, KT and Rao, M. “World Drug Firsts from Asia (Outside Japan).” Regulatory Focus. March 2016. Regulatory Affairs Professionals...
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Fact Sheet
For pharmaceutical, biotechnology and medical device companies charged to do more with less as a result of consolidation, restructuring and economic uncertainty, recent years have presented extraordinary regulatory and quality compliance challenges. Without the right attention, these challenges can weaken quality systems and processes, erode domain and critical thinking expertise, and cause core quality principles to be neglected – leaving companies vulnerable to compliance lapses and enforcement action. These issues are only exacerbated with the disparate systems that result from outsourcing or mergers and...
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White Paper
Timely recruitment of the large numbers of healthy volunteers required for Phase I trials of most biosimilars is a key success factor in this competitive sector. A multi-site approach can help maximize the sponsor’s chance of gaining first-mover advantages such as regulatory exclusivity. The entire biosimilar development program must be kept in mind when setting up Phase I, particularly if accelerated approaches are being considered, such as launching a Phase III program based on Phase I interim...
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Presentation
In an effort to improve timely access for patients to new medicines in areas of high unmet need, the European Medicines Agency (EMA) has implemented an innovative adaptive pathways approach. Adaptive pathways is a scientific concept for medicine development and data generation, which allows for early and progressive patient access to a medicine using the existing European Union regulatory framework. Adaptive pathways are based on the principles of iterative development throughout the life-cycle of a medicine where clinical trial data is supplemented by real-world evidence. A key principle is early patient and health technology board engagement.  Adaptive pathways seeks to achieve an appropriate trade off between unmet need and a wider than traditional degree of uncertainty around risks...
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Brochure
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...
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Fact Sheet
Quintiles’ HTA Watch is a web-based service offering instant access to a global repository of published HTA reports from nearly 100 agencies in 32 countries, providing regularly updated assessments to help inform life sciences and healthcare companies’ strategic decision-making*. In this edition of our HTA uncovered series, we will look specifically at the impact of market access on pharma asset valuation and will do a review of published health technology assessments in...
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Article
Today, the amount of data available through the digitalization of health record, as well as innovative approaches to data capture and analysis, are changing the way all stakeholders - from patients and physicians to drug developers and payers - interact with the healthcare...
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Case Study
Learn how a robust and integrated HCP and patient/caregiver support program utilizing Quintiles Clinical Nurse Educators significantly increased activation leading and improved adherence and retention rates for a chronic...
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