Quintiles Information Library Feed

The Right Approach for The Right Question

Fri, 18 May 2012 14:56:40 -0400

As healthcare stakeholders increasingly seek evidence to support regulatory, reimbursement and prescribing decisions, real-world and late phase research is becoming critical to ensuring the success Download the PDF

Demonstrating Value Driving Commercial Success

Thu, 17 May 2012 13:27:17 -0400

Global Market Access and Commercialization, a core practice from Consulting at Quintiles, stands ready to help you navigate the value substantiation process, from developing and demonstrating your product’s value platform to assisting in winning a preferred position on payer formularies and negotiating favorable pricing and reimbursement. Download the PDF

Devising OTC strategies for devices

Mon, 14 May 2012 17:06:02 -0400

Registering an OTC product as a medical device can provide a faster and more cost-effective way of entering the European market, according to Quintiles’ Dr Peter Lassoff. Download the PDF

中心实验室解决方案

Fri, 11 May 2012 10:28:44 -0400

昆泰全资拥有全球最大的检测网络，其所有的中心实验室都通过CAP认证，可以提供准确、可靠的可比数据，助您在新健康格局中获得成功。与昆泰联手，您将拥有全球统一的可靠数据，助您实时决策研究方向。我们对于病人安全的一贯重视，也将给您带来益处。您还能从昆泰全面的咨询和资本服务中获得新能力和新洞察。 Download the PDF

数据管理解决方案

Fri, 11 May 2012 10:17:55 -0400

作为您的合作伙伴，昆泰协助您驾驭复杂的临床数据管理过程。灵活的解决方案能满足您对速度的要求，并且无需牺牲数据的完整性和准确性。 Download the PDF

早期临床研发

Fri, 11 May 2012 10:12:44 -0400

在新健康格局里，研发管道的压力强化了对速度和效率的要求。对药物及其研发方式的选择做出迅速决策已经变得越来越关键。但是候选药物组合的效率并非仅仅依赖于速度。它需要更好的早期研究，为采取正确行动提供洞察力和优质数据。 Download the PDF

重塑安全: 全程安全管理

Fri, 11 May 2012 10:03:49 -0400

当您整合所有的安全信息时，您可以做出更好的决策，符合监管要求，更快上市。

临床

Fri, 11 May 2012 09:43:23 -0400

凭借对策略，运营，法规和市场的全面了解，昆泰将与您合作，规划并实施更智慧的临床试验和上市后研究。 Download the PDF

探知风险, 抓住机遇, 引领新健康

Fri, 11 May 2012 09:35:33 -0400

新健康需要新型合作伙伴这本公司折页介绍了生物制药行业发生的巨大变化。这种变化要求我们具备更高的效率，更快的结果，全新的资本来源，以及以更智慧的方式评估风险并执行全球性策略。新健康需要新型的合作伙伴。昆泰正帮助生物制药公司探索新的成功之路。 Download the PDF

实现美好未来：从外包到创新，亚太地区的战略转移

Fri, 11 May 2012 09:18:42 -0400

近年来，生物制药研发活动的数量在新兴和非传统市场有了显著增长，而这曾经是位于西欧和美国企业的专有领域。随着药物厂商面临的竞争压力越来越大，以及开发成本的不断上升，生物制药企业无论是大是小，都在努力抓住每一项优势实现研发价值最大化。因此，许多企业争相涌入亚太地区，以期利用这一地区突出的病人资源、低成本和经营效率优势。 Download the PDF

亚洲：药物战略开发新前沿

Thu, 10 May 2012 08:46:25 -0400

西方医药企业已开始在亚洲进行产品开发与注册，亚洲新兴医药企业也在努力提高产品全球化的能力，亚洲正在快速成为药物开发的新前沿 Download the PDF

Pioneering Pulmonary Research

Tue, 08 May 2012 16:23:33 -0400

Discover how Quintiles helped one sponsor modify their recruitment sites to generate the desired number of qualified patients to meet timelines in this Phase II double-blind, placebo-controlled efficacy and safety study for COPD patients with emphysema. Download the PDF

Validated Methods

Wed, 02 May 2012 16:55:01 -0400

Advion Bioanalytical Labs specializes in validated LC/MS methods development to support drug-drug interaction (DDI), biomarker, or comparison studies with established therapeutic compounds. Non-proprietary, validated methods Download the PDF

CYP450 Inhibition Studies

Wed, 02 May 2012 16:50:50 -0400

Many aspects of our assays can also be customized to provide you with the type of data and degree of quality assuredness that you require. Download the PDF

LC-MS-MS Services

Wed, 02 May 2012 16:46:48 -0400

At Advion Bioanalytical Labs, our scientists have years of bioanalytical method development and LC/MS/MS expertise to meet study needs. Download the PDF

Immunoassay Services

Wed, 02 May 2012 16:39:05 -0400

Advion Bioanalytical Labs provides a full range of immunoassays services, including ELISA assays, for the development and validation of traditional and custom-designed PK, immunogenicity testing, and biomarker projects. Download the PDF

Drug Discovery and Metabolism Studies

Wed, 02 May 2012 16:33:45 -0400

Advion Bioanalytical Labs offers drug discovery and metabolism services Download the PDF

Biomarker Services

Wed, 02 May 2012 16:28:08 -0400

At Advion Bioanalytical Labs, our highly trained scientists utilize novel techniques and state of the art technology to develop customized solutions for your biomarker challenges. Download the PDF

Sample Management Services

Wed, 02 May 2012 15:36:19 -0400

The Sample Management and Storage Services team supports single- or multi-site studies with hundreds to thousands of samples worldwide. Download the PDF

Optimizing Clinical Development Sourcing

Tue, 01 May 2012 15:52:24 -0400

The US Affiliate of a top 10 European based pharma company came to the realization that their clinical development sourcing model had evolved within its late stage clinical operations function. Download the PDF

Quintiles Names Tom Pike CEO

Mon, 23 Apr 2012 06:00:00 -0400

April 23, 2012 – Quintiles, the world’s leading global biopharmaceutical services company announced the appointment of Tom Pike as chief executive officer. Dennis Gillings, CBE, who founded the company, continues as executive chairman of its Board of Directors. Pike joins Quintiles on April 30, 2012.

Quintiles Grants $10,000 in Scholarships to City of Medicine Academy Graduates

Fri, 20 Apr 2012 08:00:00 -0400

April 20, 2012 – Quintiles will grant four scholarships to 2012 graduates from the City of Medicine Academy in Durham, North Carolina as the biopharmaceutical services company celebrates its 30-year anniversary.

Podcast: Addressing Compliance Challenges

Fri, 20 Apr 2012 05:33:15 -0400

Bob Rhoades and Marie McDonald, from Consulting at Quintiles, discuss some of the top reasons biopharmaceutical companies fail to make progress on the compliance maturity curve.

Robust Audit Programs

Fri, 20 Apr 2012 05:15:38 -0400

Good internal audit programs and auditing practices enable an organization to evaluate the effectiveness of its Quality Management System, and promote continuous improvement. Download the PDF

Multi-Channel Sales Solutions

Wed, 18 Apr 2012 09:55:19 -0400

The Evolving Sales Model: Innovative strategies for HCPs, Payers and Patients. Download the PDF

Quintiles’ Digital Media Innovation Receives Further Recognition

Wed, 18 Apr 2012 08:15:00 -0400

April 18, 2012 – Quintiles’ ground-breaking embrace of digital media to improve many aspects of its work has received further acclaim, this time for helping employees connect and work together more effectively.

Meeting Vaccine Trials Challenges in Emerging Markets

Tue, 17 Apr 2012 12:27:22 -0400

Ellen Vigdorth discusses the challenges of performing vaccine studies in emerging markets.

IT Strategy and Implementation

Mon, 16 Apr 2012 11:02:24 -0400

Do You Have Access to Life Science Skills and the Right Technical Expertise? Microsoft SharePoint – collaboration software that simplifiesbusiness intelligence, content management, search, and Download the PDF

Quintiles Wins Best CRO In Vaccine Excellence Awards 2012

Thu, 12 Apr 2012 13:30:00 -0400

April 12, 2012 – Quintiles, the world’s leading global biopharmaceutical services company, announced that it has been named Best Clinical Research Organization (CRO) in the Vaccine Industry Excellence (ViE) Awards 2012.

US Biosimilar Guidelines

Tue, 10 Apr 2012 15:20:31 -0400

In March 2010, section 351(a) of the Public Health Service Act was amended to create an abbreviated pathway for the approval of biosimilars or interchangeable biologic products. Download the PDF

American Diabetes Association to Collaborate with Quintiles’ Digital Patient Unit

Wed, 04 Apr 2012 08:30:00 -0400

April 4, 2012 – Quintiles and the American Diabetes Association announced a strategic agreement in which Quintiles’ Digital Patient Unit will provide the Association’s millions of website users access to Quintiles’ medication monitoring service.

Clinical Development Health Check Diagnostic

Tue, 03 Apr 2012 00:00:00 -0400

How Do You Manage the Health of Your Clinical Development Processes and Effectively Measure Performance, Control Risk, and Demonstrate Value? Download the PDF

Cancer Treatments and the Search for Value

Mon, 02 Apr 2012 15:12:25 -0400

Cancer Treatment and the Search for Value In September 2011, The Economist Intelligence Unit surveyed 399 senior executives from the life sciences industry and payer

Quintiles to Quantify Healthcare Decisions

Wed, 28 Mar 2012 09:34:49 -0400

Quintiles incorporates Archimedes’ ARCHeS Innovator into its existing solutions that span the product lifecycle.

Presentation on Impacting Patient Adherence

Fri, 23 Mar 2012 15:21:13 -0400

Education and the postive effect on patients - crucial steps and successful tools.

Pressemeldung GPTW

Fri, 16 Mar 2012 11:13:31 -0400

Zum 8. Mal als einer von Deutschlands besten Arbeitgebern ausgezeichnet: Quintiles, der Dienstleister für die Healthcare Branche Download the PDF

Quintiles Highlights Potential of Asia to Transform BioPharma

Wed, 14 Mar 2012 20:30:00 -0400

March 14, 2012 – With the biopharmaceutical industry currently balanced atop tectonic plates, industry leaders must not settle on incremental innovation, but should look toward Asia as a unique opportunity for “radical transformation,” according to a paper from Quintiles.

Commercialization Decisions

Tue, 13 Mar 2012 14:44:04 -0400

PharmaVoice, February 2012 - In recent years, the research and development landscape in the pharmaceutical industry has radically changed. The search for the next big Download the PDF

Tectonic Transformations

Tue, 13 Mar 2012 12:13:53 -0400

Incremental innovations are no longer sufficient. The biopharmaceutical industry needs a radical transformation, and Asia offers a unique opportunity for remodeling the system. Download the PDF

World Vaccine Congress

Mon, 12 Mar 2012 17:01:42 -0400

Quintiles is a Gold Sponsor and Ellen Vigdorth is speaking

Quintiles Infosario Streamlining Trials with Better Communication

Mon, 12 Mar 2012 13:38:32 -0400

The Quintiles Infosario™ Investigator Portal fundamentally changes the way clinical trial lab work is managed. Putting timely laboratory data at the fingertips of investigators, this advanced system offers greater transparency and efficiency to tighten study timelines and increase the quality of data. Download the PDF

Practical Research Solutions

Mon, 12 Mar 2012 09:31:05 -0400

In the World of Biopharmaceutical Development, Market Researchers are in the Hot Seat Crucial decisions hinge on market research guidance. With evolving stakeholder and regulatory Download the PDF

Podcast: Dispatch from CALBIO 2012

Fri, 09 Mar 2012 10:01:57 -0400

Adrian McKemey, Ph.D., Practice Leader, Product Development and Commercialization, Consulting at Quintiles, discusses a panel he moderated at CALBIO 2012.

Accelerating Success in Oncology

Fri, 09 Mar 2012 09:26:52 -0400

New Demands to Demonstrate Value Require New Strategy Proof of efficacy is no longer enough to ensure success in oncology. As the cost and complexity Download the PDF

Early Clinical Development Solutions

Thu, 08 Mar 2012 16:39:16 -0400

As the leader in clinical development services, with experience in more than 1,000 first-in-human and exploratory medical studies, Quintiles understands the intricacies of Phase 1/11a trials and decision making. Download the PDF

Pressemeldung Service Provider

Mon, 05 Mar 2012 10:46:03 -0400

Quintiles: Partner in allen Phasen des Produktlebenszyklus – für Lösungen aus einer Hand Mannheim, Februar, 2012: Seit nunmehr einem Jahr gilt das Gesetz zur Neuordnung Download the PDF

Accelerating Recruitment

Thu, 01 Mar 2012 10:42:32 -0400

A Shallow Pool Makes for a Deep Problem A large U.S.-based pharmaceutical company engaged in a Phase IIIb clinical trial found itself in an especially Download the PDF

Establishment and Operation of Clinical Endpoint Committees

Wed, 29 Feb 2012 13:07:13 -0400

This white paper provides a detailed account of the operation of Clinical Endpoint Committees. It discusses how they are formed, how information is sent to Download the PDF

Centralised Endpoint Adjudication in Cardiovascular Outcome Studies

Wed, 29 Feb 2012 12:52:48 -0400

This paper provides a succinct overview of Clinical Endpoint Committees, their role in the independent adjudication of suspected cardiovascular events during clinical trials, and the need for their employment in clinical development programs for new antidiabetic drugs for Type 2 Diabetes Mellitus. Download the PDF

Cardiovascular Safety Watch - Part 2: Regulatory Landscape for Off-Target Blood Pressure Assessment

Wed, 29 Feb 2012 12:44:39 -0400

This column provides further discussion related to a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, based on feedback from additional cardiovascular safety conferences. Download the PDF

Cardiovascular Safety Watch - DIA Cardiac and Cardiovascular Safety Conferences

Wed, 29 Feb 2012 12:35:10 -0400

This column reviews the 2nd DIA Cardiac Safety Conference in Japan (held September 5th and 6th in Tokyo), and previews the 5th DIA European Cardiovascular Safety Conference, held on November 3rd and 4th in Barcelona. Download the PDF

Cardiovascular Safety Watch - Regulatory Landscape for Off-Target Blood Pressure Assessment

Wed, 29 Feb 2012 12:24:31 -0400

This column discusses a potential future regulatory landscape for the assessment of off-target drug-induced blood pressure responses, and the challenges of deciding which parameter(s) to focus upon, and how to determine thresholds of regulatory concern. Download the PDF

Cardiovascular Safety Watch - DIA/FDA Conference on Cardiovascular Safety in Drug Development

Wed, 29 Feb 2012 12:10:16 -0400

This column provides a report of the DIA/FDA conference entitled “Cardiovascular Safety in Drug Development: State-of-the-Art Assessments,” held in Washington DC on 14-15th April 2011. Download the PDF

Cardiovascular Safety Watch - Assessments for New Oncologic Agents

Wed, 29 Feb 2012 10:01:18 -0400

This column discusses cardiovascular safety assessments for new oncologic agents, and illustrates how benefit-risk balances differ in different circumstances. Download the PDF

Cardiovascular Safety Watch - Introduction to Cardiac Safety Research Consortium

Wed, 29 Feb 2012 09:35:08 -0400

This column provides an introduction to the Cardiac Safety Research Consortium (CSRC) and a review of its 2010 Annual Meeting and accompanying Pediatric Drug and Devices Cardiovascular Safety Think Tank, in December 2010 at the FDA Headquarters (Silver Spring, Maryland). Download the PDF

Quintiles Celebrates 30 Years as Biopharma Services Provider

Tue, 28 Feb 2012 06:00:00 -0400

February 28, 2012 - Quintiles marks the 30-year anniversary of the company’s incorporation, transforming from a small statistical consulting firm to the world’s largest biopharmaceutical services company.

30 Year Anniversary

Tue, 28 Feb 2012 04:15:53 -0400

Quintiles celebrates 30 years as a Biopharma services provider

Quintiles and Russian Venture Company Biofund to Expand Clinical Development Capabilities in Russia

Fri, 24 Feb 2012 02:00:00 -0400

February 24, 2012 – Russian Venture Company Biofund, and Quintiles, announced a definitive agreement to support expansion of clinical development services within the Russian Federation, the world’s ninth most populous country.

Making Informed Decisions

Thu, 23 Feb 2012 10:12:01 -0400

Comparative effectiveness research (CER) is defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “’real-world’ settings.” Download the PDF

New and existing pharmacotherapeutic options for persistent asthma and COPD

Thu, 23 Feb 2012 08:29:18 -0400

Asthma and COPD are chronic inflammatory airway disorders with systemic manifestations. The two diseases have different airway inflammation, features of airway remodelling with subsequent pathophysiology and clinical presentation. Download the PDF

视频：更快调查不良事件

Fri, 17 Feb 2012 11:32:39 -0400

了解Quintiles Infosario™如何帮助你快速找到有关不良事件的信息，包括实验室、心电图、病史和辅助药物治疗等各个方面。所有信息都来自一个整合的信息系统。体验如何能够在问题变得严重之前迅速深入研究，进行联系和更快地解决不良事件。

Quintiles Expands Commercial Services in Middle East and North Africa

Tue, 14 Feb 2012 18:00:00 -0400

February 14, 2012 – Quintiles is extending its global footprint to provide commercial services in the Middle East and North Africa (MENA) region through an agreement with Dayarn Pharma.

Quintiles Launches New Capabilities to Enable Biopharma Success in Asia

Thu, 09 Feb 2012 05:37:06 -0400

February 13, 2012 – Quintiles launches two unique services – Strategic Drug Development and Consulting at Quintiles – to bolster the probability of success in developing and commercializing new medications in the region.

Oncology Experience

Tue, 07 Feb 2012 15:43:58 -0400

Quintiles acquires Outcome to offer full spectrum of inventional and observational research. Together, we offer the expertise and experience in real-world and late phase research Download the PDF

Turkey Oncology Capabilities

Mon, 06 Feb 2012 16:00:00 -0400

Turkey has outstanding access to patients with a population of almost 75 million. Quintiles recent experience demonstrates Turkey provides rapid patient enrollment with high patient retention rates and remains an emerging market with few competing studies – becoming a major hub for patient recruitment. Download the PDF

India Central Laboratory Services

Mon, 06 Feb 2012 15:45:17 -0400

Quintiles offers a local presence in India alongside seven other wholly owned labs and two affiliates strategically located around the world. Over time, we have developed key relationships in local regulatory and shipping communities, giving us the ability to support investigators in India, elsewhere in Asia or around the globe. Download the PDF

Fact Sheet Brand Management

Mon, 06 Feb 2012 13:05:02 -0400

Fact Sheet Brand Management Download the PDF

Middle East Oncology capabilities

Mon, 06 Feb 2012 10:51:54 -0400

Outstanding access to patients in the Middle East region with a population of over 200 million means this is an important emerging region for the biopharmaceutical industry and Quintiles has a proven track record of rapid patient enrollment with high patient retention rates. Download the PDF

South Africa Central Laboratory Services

Mon, 06 Feb 2012 10:37:14 -0400

Quintiles offers a local presence in Africa alongside seven other wholly owned labs and two affiliates strategically located around the world. Over time, we have developed key relationships in local regulatory and shipping communities, giving us the ability to support investigators in Africa or around the globe. Download the PDF

DIA China

Fri, 03 Feb 2012 11:56:04 -0400

Quintiles will have a presence

FDA News Annual Risk Management and Drug Safety Summit

Fri, 03 Feb 2012 11:52:18 -0400

Outcome will have a presence

International Conference on Pharmacoepidemiology and Therapeutic Risk Management

Fri, 03 Feb 2012 11:44:53 -0400

Outcome will have an exhibit presence

Health Technology Assessment International Conference

Fri, 03 Feb 2012 11:39:58 -0400

Outcome will have a presence

ISPE Mid-Year Symposium

Fri, 03 Feb 2012 11:29:27 -0400

Outcome will have a presence

Fact Sheet

Fri, 03 Feb 2012 11:20:38 -0400

Vacancy Management Download the PDF

Reinventing Biopharma

Wed, 01 Feb 2012 17:07:14 -0400

The biopharmaceutical industry today is facing a multifaceted “value challenge.” Download the PDF

Expected Growth of Industry-Sponsored Clinical Trials in the Middle East Benchmarked on other Global Regions

Wed, 01 Feb 2012 06:01:22 -0400

The evolving business model in the biopharmaceutical industry depends on increased productivity in clinical trials. This demands lower-cost, faster and more effective clinical trial processes. Download the PDF

Pharmaceutical Executive: The Power of Observation

Mon, 30 Jan 2012 18:06:15 -0400

Observational studies present a compelling real-world corollary to the classic randomized clinical trial. Download this article to learn how you can build your evidence portfolio. Download the PDF

Registries for Evaluating Patient Outcomes: A User's Guide

Mon, 30 Jan 2012 17:40:39 -0400

Outcome leads the development of best practices for designing and implementing patient registries for real-world observational research. Download the Agency for Healthcare Research & Quality (AHRQ) 2nd edition of Registries for Evaluating Patient Outcomes. Download the PDF

Accelerating Patient Recruitment

Thu, 26 Jan 2012 11:40:33 -0400

Presentation at the CBI Oncology Commercialization Strategies Summit by Dr. Stewart Rosen on Clinical Trial Educators in Oncology

Thinking Outside the "Sales" Box

Thu, 26 Jan 2012 11:34:26 -0400

Learn how Clinical Educators access practitioners, nursing and patients to drive better diagnosis and better patient care.

The Power of Observation

Thu, 26 Jan 2012 07:33:26 -0400

As the name implies, in observational studies one 'observes.' The choice of therapy is determined by the patient and her physician rather than protocol, and, Download the PDF

Making Observational Studies Count

Thu, 26 Jan 2012 07:28:27 -0400

There is substantial interest in using observational epidemiologic research in combination with randomized clinical trials (RCTs) and meta-analyses to support decisionmaking by regulators, payers, and Download the PDF

Patient Registries for Understanding the Natural History of Diseases

Thu, 26 Jan 2012 07:20:15 -0400

Understanding the natural history of a disease - its characteristics. management. and outcomes with or without treatment - is critical for developing new therapies. identifying Download the PDF

GRACE Principles: Recognizing High-Quality Observational Studies of Comparative Effectiveness

Thu, 26 Jan 2012 07:15:05 -0400

Comparative effectiveness (CE) has been defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, Download the PDF

Quintiles Forms New Biomarker Research and Development Company

Wed, 18 Jan 2012 06:00:00 -0400

January 18, 2012 – Quintiles announced that it has invested in a new company formed to provide oncology consulting services and new cancer biomarkers, the key to scientific selection of the right drug for the right patient.

Cardiac Safety Solutions

Tue, 17 Jan 2012 16:07:09 -0400

Learn how you can proactively assess and manage cardiac safety issues for your entire product development process with the help of our cardiovascular experts and core ECG laboratory providing validated methodology, sophisticated technology and reliable data. Download the PDF

Quintiles Launches Innovative Center of Excellence in Dalian, China

Tue, 17 Jan 2012 13:22:07 -0400

January 17, 2012 – Quintiles is opening a business process outsourcing (BPO) and project management center of excellence with a multilingual workforce and location ideally suited to serve the Japanese, Chinese and South Korean biopharmaceutical markets.

Quintiles Infosario Clinical Trial Management System Fact Sheet

Tue, 17 Jan 2012 08:59:19 -0400

A fully hosted, global Clinical Trial Management System(CTMS) that provides scalable functionality across multiple business processes. A key component of our Systems as a Service offering, the Quintiles Infosario CTMS provides a centralized location for capturing, viewing, and sharing clinical trial data—from site identification to study closeout. Download the PDF

The Contribution of Early-phase Clinical Data to a Drug’s Integrated Cardiac Safety Portfolio

Mon, 16 Jan 2012 12:00:00 -0400

This article examines the financial and time benefits to incorporating intensive ECG and QT/QTc monitoring in early-phase clinical studies.

ISPOR Europe 2012

Thu, 12 Jan 2012 11:50:04 -0400