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Featured White Paper

Harnessing vital data to inform an optimal market access strategy in the UK
Market access now demands closer collaboration between biopharma, payers and providers. In a climate where ongoing reimbursement of a drug relies on biopharma’s ability to demonstrate how it delivers value to the entire healthcare system, partnership working is essential. Outcomes audits should be seen as one of the most important tools available to biopharma. They deliver detailed action plans to both biopharma and the NHS, proposing improvements to the care pathway...


















































































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    Media Coverage
    On Tuesday, Dr. Jeff Spaeder, Quintiles Chief Medical and Scientific Officer, was interviewed via satellite by Jim Cramer, CNBC’s host of the investment segment, "Mad Money," which airs daily in the US, New Zealand and Australia. As host of Mad Money, Cramer works to guide the more than 166,000 cable viewers through the confusing jungle of Wall Street investing. According to Cramer, the Ebola crisis is causing uncertainty among investors so he wanted insights from the experts in drug development. This is the player to use for single videos on Q.com ...
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    Presentation
    Whether you are an investigator, trial sponsor or manufacturer of products or devices, compliance with safety reporting requirements to Chinese FDA has never been so critical on the heels of tightening regulations and increased scrutiny. In this short presentation, Deirdre McCarthy, Senior Benefit-Risk Management Director at Quintiles, discusses clinical trial safety reporting requirements for both sponsors and investigators, with a special segment on vaccine safety reporting. She also covers post-marketing requirements before finishing with an update on a recent medical device regulation in China. To see our full webinar, please click...
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    Presentation
    This webinar, presented by Dr. Louise Parmenter, PhD, Global Head of Operations, Epidemiology & Outcomes Research, Real-World & Late Phase Research and Ms. Anke van Engen, MSc, Senior Consulting Director, Practice Leader HTA Solutions at Quintiles, addresses how to optimize your real world evidence research by seeking first to understand the needs of the broad spectrum of decision-makers and then marrying these needs with insights into real-world data access and availability. This webinar focuses on the challenge for sponsors to meet a diversity of evidentiary needs in a complex and changing market. The webinar includes case examples, and our recommended approach to drive real-world-evidence, using real-world insights, for a more impactful and streamlined portfolio of real-world...
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    White Paper
    Liver cancer is a leading cause of cancer-related death worldwide. It is the fifth most common cancer in men (554,000 cases, 7.5% of the total) and the ninth in women (228,000 cases, 3.4%). In men, the regions of high incidence are Eastern and South-Eastern Asia (ASRs 31.9 and 22.2 respectively). In women, the rates are generally much lower. Liver cancer is the second most common cause of death from cancer worldwide, estimated to be responsible for nearly 746,000 deaths in 2012 (9.1% of the total) and prognosis is very poor. Hepatocellular carcinoma (HCC) is the most common type of liver cancer. The incidence of HCC is expected to rise in the United States and across the world, given the increasing prevalence of hepatitis C and B infections, alcohol consumption, diabetes, toxin exposure,...
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    White Paper
    In clinical trials, maintaining acceptable data retention rates is a challenging task, especially in long-term follow-up studies. The US Food and Drug Administration (FDA) has declined certain drug applications for approval largely due to concerns over missing follow-up safety data and methodological issues with the trials in the drugs’ clinical development programs. This emphasizes the critical importance of a robust process for obtaining data retention and survival status information for all patients enrolled in an investigational trial.  With key milestones on the line, the Quintiles project team for the TRILOGY Acute Coronary Syndromes (ACS) clinical trial developed and implemented a robust data retention process to ensure maximum control of subject retention during the study. At...
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    Fact Sheet
    Quintiles Laboratory Facility in Pretoria, South Africa was established in 1999. This BSL3, CAP-accredited, full-service laboratory includes capabilities spanning: Pre-analytical,  Analytical, Project Services, Specimen Management and Storage, Clinic supplies, and Logistics support.   These end-to-end services are tailored to meet the complexities of providing clinical trial sites support in South Africa, and are set up to help ensure timely turn-around of testing and result reporting, safe handling and transport of samples, and best-in-class project...
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    White Paper
    In the past, when smaller U.S. biopharmaceutical companies wanted to enter the European market, they had two choices – go it alone, an approach that includes substantial cost, risk and uncertainty; or out-license the product to another company, which required them to give up control of the product and perhaps lessen the long-term value of their portfolio. Now they have a third option. By partnering with a well-established outsourcing specialist they can overcome much of the risk while taking advantage of a vast network of human resources and infrastructure across Europe. Through these partnerships, smaller biopharma companies can more efficiently get their drug into the market – without giving up strategic control or long-term value.  This paper outlines the challenges North American...
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    Fact Sheet
    The market access challenge requires a successful response to multiple stakeholders from different countries – each with their own needs and requirements. Anticipating these diverse demands and developing the necessary evidence requires a nuanced understanding of the dynamic payer environments you must navigate. Quintiles’ HTA Accelerator offers an integrated solution providing payer insights for launch...
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    Fact Sheet
    Healthcare systems across Asia Pacific are evolving - as expenses rise alongside improvements in care, payers are increasingly demanding proof of value from new medicines. For today’s drug developers, the emphasis has shifted from “time to market” to “time to access.” By clearly communicating a strategic and cohesive value message to key stakeholders, the path to market access can be navigated more effectively and efficiently. Discover how Medical Science Liaisons (MSLs) can be an integral part of your team and gain a deeper insight into: The difference between a traditional sales representative and a MSL How MSLs can help to prepare the market during the pre-launch phase Effectively engaging with key opinion leaders (KOLs) and stakeholders Best practice and key success...
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    Fact Sheet
    Getting a clinical trial off to the right start is vital. However, across the industry, trials face multiple delays and 20% of sites recruit zero patients, due to the scarcity of good information. An optimized approach to start-up that leverages data, analytics, process expertise and site relationships has enabled faster start-up. See how Quintiles’ can establish a solid route to trial execution...
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    Press Release
    RESEARCH TRIANGLE PARK, NC – October 14, 2014 – Quintiles today announced that the company was awarded the Society for Clinical Research Sites’ (SCRS) 2014 Clinical Research Organization (CRO) Eagle Award. The award, which recognizes outstanding leadership, professionalism, integrity, passion and dedication, was presented during the annual SCRS Site Solutions Summit. "It is such an honor to be recognized again and receive this award for the second year in a row,” said Lindy Jones, senior vice president, Integrated Site Services, Quintiles. “Our ambition of transforming clinical development and accelerating pipelines to achieve better patient outcomes is only possible through the dedication and hard work of our investigators and sites. I would like to thank the investigators who voted for...
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    White Paper
    How is next generation sequencing (NGS) transforming oncology clinical development and treatments for cancer?  Read this recent whitepaper to learn how.  The overall goal in the era of emerging precision is to develop cancer medications that attack the right target, or targets, in the right disease, in the right patient, at the right dose to obtain the desired outcome.  Several targeted therapies have successfully been developed and the pipeline of additional precision medicines looks promising.  But how can the drug development community better capitalize on sophisticated genomics-based tools available to help transform clinical development and cancer care in the coming decade? This paper investigates fundamentals and key considerations to integrating NGS in the clinical development of...
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    Presentation
    Biopharma’s success in the new healthcare economy is predicated on one simple principle: prove the value of your treatments or risk losing market share and profits. Healthcare costs are climbing, regulators around the globe are requiring more information, and both providers and payers have higher expectations for a medical treatment’s proof of value before prescribing or paying for those treatments. These quality, cost and outcome driven imperatives must also incorporate efficacy, safety, benefits as compared with competing products, and overall improved quality of life.  Download the presentation given by Paul Sutton, Director of Outcomes at Quintiles Commercial UK, entitled: “Value is the target: aligning value for payers to pharma”.  Paul Sutton leads the design and implementation of...
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    Presentation
    Biopharma's success in the new healthcare economy is focused on a clear guiding principle: prove the value of the product to all stakeholders, or risk commercial failure. In the UK, the number of budget holders has vastly increased, with NICE, NHS England, the Cancer Drug Fund and the proliferation of clinical commissioning groups all now demanding drugs that deliver exceptional value. 'UK payers perspectives: the market access value paradox' features Ryan Wooller, Director of Market Access and Service Innovation at Quintiles and Dr Junaid Bajwa, a GP and board member for Greenwich CCG. The webinar will examine exactly why there is a misalignment between biopharma and payers, how it is harming the commercial and clinical success of products, and what needs to be done to bring them closer...
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    Media Coverage
    An overview of benefit-risk management in the lifecycle of medical procedures and the effect of recent EU legislation (in German) from PM Report. Link to Christoph’s blog on Quintiles.com - http://www.quintiles.com/experts/christoph-schnorr Bekommen Sie einen Überblick über Benefit-Risk Management im Lebenszyklus von medizinischen Verfahren und die Auswirkungen der letzten Gesetzesänderungen auf EU Ebene - PM Report. Link zu Christoph’s blog on Quintiles.com -...
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    Fact Sheet
    When it comes to central lab performance, you expect speed and accuracy. And that’s what you’ll get through online access to Quintiles Infosario® Analytics and Infosario Site Gateway, connected to all of your trials run through Quintiles Central Labs.   Learn how Quintiles’ Infosario technology platform enables study sponsors to see trial lab data at a deeper level to improve the quality of their...
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    Brochure
    With new technologies and partnerships opening up unprecedented access to patient data, generating evidence that can demonstrate the effectiveness and safety of your products under real-world conditions is more important than ever. Many healthcare stakeholders, including physicians, payers and regulators, are all seeking real-world outcomes to determine what works best for different patient subgroups in different situations. Observational research and patient registries can deliver this type of evidence to meet your stakeholders’...
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    Media Coverage
    Since its founding in 1982, Quintiles has become a leading clinical research organization, from first-in-human studies to post-launch monitoring. In 2013, Quintiles acquired Expression Analysis (EA) to expand its genomic testing analysis services throughout the entire process of drug discovery and development. Dr. Patrick Hurban, a trained molecular biologist and geneticist and EA’s Global Head of Genomic R&D, tells Nature how the marriage between EA and Quintiles benefits...
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    Press Release
    RESEARCH TRIANGLE PARK, N.C. – September 30, 2014 – Quintiles Transnational Holdings Inc. (NYSE: Q) will release its third-quarter 2014 financial results Thursday, October 30, 2014 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) 484-7367 in the United States or +1 (631) 259-7541 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 Thursday, October 30th. About Quintiles Quintiles (NYSE: Q), a Fortune 500 company, is the...
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