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Fact Sheet
The biopharma industry is experiencing a paradigm shift in the outsourcing of regulatory affairs operations. In particular, this trend is being adopted by biopharma companies with marketed and mature products who are seeking strategic partners to manage their post-approval regulatory operations. In addition, emerging companies do not have substantial global resources to...
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White Paper
Executing clinical studies using risk-based Monitoring (RBM) methodologies is reducing risks in clinical development, while improving patient safety and study quality. Clinical trial site engagement is critical to your study’s performance and ultimately, its success. Read this article to understand how your Investigator Sites can improve overall site performance; learn...
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Press Release
DANBURY, CT and RESEARCH TRIANGLE PARK, NC, September 14, 2016 – IMS Health Holdings, Inc. (NYSE:IMS) today announced the pricing of its offering of $1.75 billion equivalent in gross proceeds of senior notes, consisting of $1.05 billion of U.S. Dollar notes and €625 million of Euro notes to be issued by its wholly owned subsidiary, IMS Health Incorporated. The offering...
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Brochure
Learn how to transform your clinical development with Quintiles' risk-based monitoring solution - Data-driven Trial Execution.According to a 2016 study by the Tufts Center for the Study of Drug Development, for a single new drug, drug development costs can be $2.6B and take 10 years, with a significant portion of that cost attributed to trial operations.Regulatory bodies...
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Press Release
DANBURY, CT and RESEARCH TRIANGLE PARK, NC, September 12, 2016 – IMS Health Holdings, Inc. (NYSE:IMS) today announced that its wholly owned subsidiary, IMS Health Incorporated, intends to raise $1.5 billion equivalent in gross proceeds through an offering of senior notes. The company is planning to issue two separate tranches of notes, one in U.S. Dollars, due 2026, and...
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Presentation
The adoption of risk-based monitoring (RBM) is both increasing and deepening, impacting the execution of clinical trials of all sizes and phases.  But much is required to ensure RBM studies go well, with roles and processes changing with innovative technology use. Download this webinar as Quintiles shares recent research results and our view of the status of RBM, along...
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Article
Risk-based monitoring (RBM) is transforming how clinical studies are being executed and managed. Clinical development is at a crossroads - it costs too much and takes too long to develop and bring new therapies to market. With support from the Food and Drug Administration, other global regulatory bodies and industry consortia, risk-based monitoring (RBM) is transforming...
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Press Release
DANBURY, CT and RESEARCH TRIANGLE PARK, NC, August 29, 2016 – IMS Health Holdings, Inc. (NYSE:IMS) and Quintiles Transnational Holdings Inc. (NYSE:Q) today announced key senior management roles in the future Quintiles IMS corporate leadership team, subject to the completion of the merger.Senior functional leaders reporting to Chairman and Chief Executive Officer Ari...
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White Paper
This white paper discusses partnering solutions that are specifically tailored for emerging biopharma. Given tremendous advances in this segment of the overall biopharmaceutical market, even though each company may only have one or two assets, the total pipeline is equivalent to roughly two-thirds of the entire global industry pipeline.Emerging biopharma is well served by...
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White Paper
Medical device makers are bullish about the future in general and about Asia-Pacific in particular. With a current commercial market size of USD $55 billion to $60 billion1,2, the region is a hot spot for medical device companies worldwide for sales, investment and expansion.This paper looks at the factors behind the attractiveness of Asia-Pacific for medical device...
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Fact Sheet
Today’s biosimilar landscape is characterized by rapid growth, intense competition, a diverse set of challenges, and large opportunities. As originator biologics go off patent, biotech companies are developing biosimilars to capture their share of a lucrative market. Sponsors aiming to capitalize on “first mover” advantages in major markets need an experienced partner...
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Presentation
Learn more about our pre-conference activities at ICPE 2016.
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Presentation
Learn more about Quintiles presentations and posters at ICPE 2016.
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Presentation
As an investigational compound progresses from early phase randomized clinical trials to being approved for prescribing to patients in physician practice, the research focus shifts from ‘Does the drug work’ to ‘Does the drug work in real world settings?’ Ideally, data collection on observational study designs should reflect standard of practice care at physician visits...
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Article
Since the new EU pharmacovigilance legislation came into force in 2012, large volumes of data relating to post-authorization safety studies (PASSs) that drug companies conduct in Europe have become privately available. These data cover such things as regulatory methodological and operational considerations for post-approval studies. They provide a rich source of...
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White Paper
This is the second of a three-part series of reports that explore strategic models for growth in Asia Pacific.  The first in the series, "Affordable therapies: Gaining a competitive advantage in Asia Pacific,” examined the strategy of developing lower-cost medicines to serve a huge unmet need.  "Innovation the Asia way: Moving at 'Asia speed' with world-class quality"...
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White Paper
“The Art & Science of Evidence – Rare Disease: An integrated, patient-centered approach to research and commercialization” is one in a series of compendia featuring blogs and bylined articles from Quintiles’ experts. This collection highlights some of our recent thinking on how to better conduct rare disease research through patient-centric approaches to inform trial...
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White Paper
The U.S. has been among the most sought-after pharmaceutical markets in the world for decades, however accessing this enormous market is not easy. Not only must entrants gain marketing approval from the Food and Drug Administration, they must also ensure access to patients by gaining prescriber and payer acceptance. Meeting the combined challenges of marketing approval,...
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Presentation
A comprehensive slide deck outlining Quintiles Pediatric Center of Excellence's core capabilities & differentiation.
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White Paper
Real-world evidence (RWE) studies – which are increasingly required to demonstrate product value in settings that reflect actual care settings – demand different approaches from traditional, randomized clinical trials. Data typically covers outcomes, and may come from observational studies, pragmatic trials, or database studies. This paper discusses best practices to...
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