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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...
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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...
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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...
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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...
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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...
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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 system.
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Article
In 2015, the U.S. Food and Drug Administration (FDA) approved 21 new drugs to treat rare diseases, which was almost half (47%) of all novel drugs approved in 2014. [i] It was also the second consecutive year the FDA approved more rare disease drugs than any previous year in history, highlighting an important trend: After decades of neglecting rare diseases research,...
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Presentation
Risk-based Monitoring (RBM) is quickly becoming the standard model for clinical development trial execution.  Quintiles, as the RBM market leader, is delivering benefits from their RBM approach to improve data and study quality, enable faster, more informed decisions, and enhance patient safety, while mitigating risk. Register here to download the webinar Register for...
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Article
Knowledge of the fetal effects of maternal medication use in pregnancy is often inadequate and current pregnancy pharmacovigilance surveillance methods have important limitations. Patient self-reporting may be able to mitigate some of these limitations, providing an adequately sized study sample can be recruited.
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Fact Sheet
Since its release 11 years ago, ICH Guideline E14 has governed the clinical proarrhythmic cardiac safety regulatory landscape: it has been adopted by the United States Food and Drug Administration (FDA), Health Canada, the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The guideline addresses the Thorough QT/QTc (TQT)...
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Video
The healthcare industry is characterized by advances in knowledge and breakthroughs. The new healthcare landscape is interconnected and increasingly complex. How do you navigate it effectively? Quintiles can help you make a healthcare breakthrough.
Fact Sheet
Why not free up your senior-level regulatory resources to focus on the strategic decision making and have the more routine maintenance activities done by capable, experienced and more appropriate regulatory experts? Quintiles can help you keep focused on your key strategic activities by providing a more optimal and efficient model for maintaining the myriad routine...
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Press Release
SINGAPORE – March 24, 2016 – Quintiles last night was named the “Best CRO in Asia” at the 2016 BioPharma Asia Industry Awards, winning the honor for the fourth time in the event’s six-year history.  The award goes to the contract research organization that best demonstrates an ongoing commitment to improving clinical research services in Asia and reducing lead times for...
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White Paper
“Affordable therapies: Gaining a competitive advantage in Asia Pacific” is the first in a three-part series of series of thought leadership reports exploring strategic models for growth in Asia Pacific, the challenges and opportunities biopharma companies face, and what they can do to position themselves for success.  This paper examines how companies can bridge the gap...
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Video
Video on how Study Coordinators (SCs) can support in planning for recruitment in clinical trials.
Article
As patients, medical care providers, regulators and policymakers seek additional evidence about the safety and effectiveness of various treatments as used in real-world settings, new study designs are needed to efficiently and effectively address these challenging research questions. While challenges exist, secondary health data such as electronic medical records and...
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Article
As patients, medical care providers, regulators and policymakers seek additional evidence about the safety and effectiveness of various treatments as used in real-world settings, new study designs are needed to efficiently and effectively address these challenging research questions. While challenges exist, secondary health data such as electronic medical records and...
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Video
In this brief video, the mother of a cystic fibrosis patient talks about the hope of finding a cure while Chief Medical and Scientific Officer Jeff Spaeder describes Quintiles' commitment to patients around the globe to find better outcomes that will lead to improved health.
Article
Quintiles has provided clinical services for >230 rare disease studies in 70 countries since 2010. In this article published by Contract Pharma, Dr Cynthia Jackson, Vice President at Quintiles, writes about how we need to think differently about rare disease clinical development.
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