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Accommodating Phase I patient recruitment for a rare indication
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Press Release
RESEARCH TRIANGLE PARK, N.C. – February 5, 2016 – Quintiles, the world’s largest biopharmaceutical services company, has been awarded the HR.com 2016 Leadership Excellence Award for Innovation in Deployment of Leadership Programs.    HR.com, the largest global social networking and resource site for HR professionals, is committed to providing a deeper understanding of the HR function for over 250,000 members. For more than 33 years, they have identified and recognized the top organizations that develop their leaders. This year’s awards had more than 4,500 companies apply with 600,000 people voting on their programs to provide the most comprehensive ratings ever produced. These prestigious leadership awards salute the world’s best leadership practitioners and highlight their roles in the...
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Brochure
The Executive Vision Forum is an annual event that brings together top industry experts in a small, intimate environment to discuss, debate and digest the rising trends, innovations, challenges and opportunities facing biopharma today.Hosted in New York City on November 6, the 2015 forum focused on the need to transform clinical development by incorporating the needs of critical stakeholders, especially patients and payers, at the very beginning of the product development lifecycle to improve efficiency and create a targeted approach to asset development that improves the probability of market acceptance. Discussions at the event centered on: Innovations in digital healthcare further enabling patient engagement. The role of the patient in product development and defining value to...
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White Paper
Pre-profiling – prospectively stratifying patients through genomic screening – was developed to provide value to patients via access to rapid, broad-based genomic testing of their cancer and to drive value to clinical study sponsors through faster recruitment of niche patient populations. Pre-profiling is a core component of Quintiles Precision Enrollment, which connects the right patient to the right trial...
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Video
Dr. Nancy Dreyer, global chief of Scientific Affairs for Quintiles’ Real-World & Late Phase Research division, shares details about conducting enriched studies with prospective and retrospective data and their potential to answer more research...
Fact Sheet
A purely prospective approach to real-world research can result in long timelines – and still may not answer all of your questions. By integrating the wealth of existing data with primary data from physicians and patients, enriched studies for real-world research can greatly increase the amount of information available on your target population, helping you dig deeper into the everyday practice of...
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Video
Quintiles' VP Peter DiBiaso discusses Project Leadership and Partnering with mid-market...
Video
Quintiles' SVP Stacie Yonkin discusses partnership and innovation with mid-market...
Infographic
There are many challenges facing clinical development today: study protocol complexity, costs, finding the right sites and patients, and data integration complexity are just a few. Risk-based monitoring (RBM) is becoming an industry standard in order to mitigate these risks and challenges. Partner with Quintiles, the RBM market leader, to reduce risks and costs, improve data quality, and enhance patient safety. Learn more about how you can execute your RBM trials with confidence by partnering with Quintiles in our latest RBM...
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Brochure
Whether you need support with medical writing, developing a robust evidence generation strategy, or scaling your pivotal Phase III trial, Quintiles’ solutions are tailored to meet the needs of our emerging biopharma customers. When you partner with us, you’ll receive the flexibility and personalized customer service you desire while accessing the capabilities you...
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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 fully collaborative outsourcing arrangements with service providers. In an increasingly complex drug development and healthcare environment, it is extremely important for companies to be able to demonstrate value, even if their intention is to be acquired or to out-license their asset following proof-of-concept. Transitioning from transactional to fully integrated outsourced partnering options can be extremely...
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Press Release
RESEARCH TRIANGLE PARK, N.C.-- Quintiles Transnational Holdings Inc. (NYSE: Q) will release its fourth-quarter 2015 financial results Thursday, February 11, 2016 prior to its quarterly earnings call at 8:00 a.m. EST. 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. EST on Thursday, February 11th. About Quintiles Quintiles (NYSE: Q) helps biopharma and other healthcare companies...
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Fact Sheet
Biosimilars studies require a cost-effective, global solution for both the efficient recruitment of healthy volunteers and for the collection of accurate data to help seamlessly transition studies from Phase I to Phase III. Quintiles has developed a comprehensive suite of services, with central oversight provided by experienced project managers, to help meet the demands of these trials and to fast track biosimilars...
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Brochure
Pharmaceutical success rests on a simple principle: prove the value of your treatments, or risk losing the chance to gain market access for your product. With overall healthcare costs climbing, payers have higher expectations for a medical treatment’s proof of value before paying for it. Germany in particular has a set of very specific regulatory requirements that make market access different than in other countries. The legislation in the German healthcare environment especially contributes to a complex market access strategy. There are also different stakeholder groups with distinctive needs that must be met. Read our brochure and learn how Quintiles can help you maximize opportunities in the German...
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Infographic
Today, there are increased opportunities for new biosimilars development. Hundreds of biosimilars are in development today. But the demands of biosimilars development are unique. Delivering a successful and timely early phase biosimilars study is dependent on a number of key factors. Read more about it in our latest...
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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 evaluation of Hepatitis C treatments and we will benchmark companies in our HTA performance...
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Infographic
Safety can’t wait. That’s why we’re always ready. When you partner with Quintiles, our world-class cross-functional teams will deliver comprehensive patient safety solutions across your product’s lifecycle – from clinical to late-phase to real-world. Click on our infographic to learn about Quintiles' suite of integrated, comprehensive safety services and learn the importance of having a steady partner from start to finish, whatever your project needs and wherever you are in the product...
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Infographic
Development of new vaccines presents an array of challenges, including recruiting special populations, addressing fragile viral sample logistics and entering endemic geographies – often under tight timelines. To address these challenges, Quintiles’ dedicated team of vaccine experts led by the Quintiles’ Vaccines Center of Excellence (COE) provides global expertise in vaccines, helping sponsors integrate operational, regulatory and commercial aspects of their programs for improved...
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Infographic
The Asia Pacific Emerging Biopharma Solution provides dedicated and numble operational support combined with Quintiles' unmathced depth of expertise and breadth of perspective across the...
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Case Study
Developing a flexible study approach and recruiting and retaining the right...
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Article
Since its release 10 years ago, ICH Guideline E141 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 goal of premarketing proarrhythmic cardiac safety investigation is to determine to the greatest degree possible whether a non-cardiac drug (a drug for a non-cardiac indication) has the propensity to lead to a rare but potentially fatal polymorphic ventricular dysrhythmia, Torsades de Pointes,2 in patients who may be prescribed the drug should it subsequently receive marketing approval. The guideline addresses the Thorough QT/QTc (TQT) Study, a dedicated trial...
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