Quintiles Information Library Custom 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

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

Understanding the Complexity of HTA Networks

Sun, 27 Nov 2011 15:07:38 -0400

As stakeholders’ influence shifts, demonstrating value is imperative for the success of every pharmaceutical product. Learn more about Quintiles HTA Watch service. Download the PDF

Quintiles Strengthens Late Phase Offerings with Acquisition of Outcome Sciences, Inc.

Wed, 19 Oct 2011 12:30:00 -0400

October 19, 2011 – With late phase (Phase IIIB and Phase IV) research becoming increasingly important to multiple healthcare stakeholders, Quintiles has acquired Outcome Sciences, Inc. (Outcome).

Quintiles Names New Global Head of Clinical & Data Operations

Thu, 06 Oct 2011 06:00:00 -0400

October 6, 2011 – Quintiles announced that Steven Skolsky has been appointed Global Head of its Clinical & Data Operations (CDO) unit.

Quintiles Approach to "Real-World" Research helps Biopharma Customers Drive Competitive Advantage

Mon, 19 Sep 2011 06:00:00 -0400

September 19, 2011 –A perfect storm of stakeholder demands, unprecedented data access, new data channels and technologies is driving a dramatic shift in research methodologies among biopharmaceutical companies, according to a new report from Quintiles.

How Informative is Your Segmentation?

Thu, 15 Sep 2011 12:25:09 -0400

Article published by Quintiles' Pieter Sheth-Voss in the Winter 2010 issue of Market Research magazine was recently awarded the David K. Hardin Memorial Award for 2011. Download the PDF

Methods Matter

Mon, 18 Jul 2011 07:41:22 -0400

As healthcare decision making becomes more complex, stakeholders are demanding real-world evidence tailored to their own individual needs. Download the PDF

A Focus on CNS

Fri, 01 Jul 2011 15:20:45 -0400

Quintiles is your ally for broad and deep CNS expertise in every aspect of the drug development process. Download the PDF

KoNECT & Quintiles Partner to Advance Clinical Research

Mon, 30 May 2011 01:00:00 -0400

May 30, 2011 – The Korea National Enterprise for Clinical Trials (KoNECT) and Quintiles have partnered to produce educational events in South Korea for investigators and biopharmaceutical companies.

Quintiles Joins the I-SPY 2 Breast Cancer Trial

Thu, 14 Apr 2011 08:00:00 -0400

The I-SPY 2 clinical trial involves 800 patients with advanced breast cancer, and employs innovative adaptive trial design and genetic and biological markers from individual patients’ tumors to screen multiple investigational therapies simultaneously.

Leveraging social networks to conduct observational research

Sat, 26 Mar 2011 10:22:47 -0400

Quintiles’ presentation describes the benefits of social networks in terms of patient identification, cost and time, relative to traditional observational research approaches.

Late Phase Research

Mon, 14 Mar 2011 14:27:58 -0400

Integrated solutions to define, demonstrate and communicate product value Download the PDF

The Use of Large Simple Trials

Fri, 25 Feb 2011 12:49:37 -0400

Quintiles presentation at CBI Late Phase Conference explores the design and application of Large Simple Trials as a cost effective approach to delivering high quality observational research data.

Clinical – Smarter Trials, Accelerated Outcomes

Wed, 16 Feb 2011 09:25:24 -0400

Quintiles will work with you to plan and execute the smartest clinical trials and post-marketing studies, informed by a holistic view of strategic, operational, regulatory and marketplace issues. Download the PDF

Population PK/PD - Modeling and Simulation Optimization Tools

Fri, 11 Feb 2011 14:05:21 -0400

Population pharmacokinetic/ pharmacodynamic (PK/PD) modeling and simulation, available from Quintiles, is now endorsed by the FDA as often being instrumental in drug approval and labeling. Download the PDF

Oversight Group Management Services - Aligned Action

Wed, 02 Feb 2011 13:56:49 -0400

From data monitoring committees and endpoint adjudication to core laboratory oversight, Quintiles provides a one-stop solution for managing oversight groups. Download the PDF

Risk Management in the US ISoP2010

Tue, 23 Nov 2010 11:41:48 -0400

Deirdre McCarthy's Presentation at ISoP 2010 on Risk Management in the US Download the PDF

Exclusive Report From Scientific American

Tue, 09 Nov 2010 08:55:28 -0400

In-depth insights on every angle of the changing health landscape - brought to you by Quintiles Get the report today.

The New Health Clinical Brochure

Tue, 31 Aug 2010 14:34:37 -0400

Japanese version available for download. Download the PDF

Precision Planning

Thu, 24 Jun 2010 15:37:44 -0400

For a Global trial, our customer worked with multiple players, including affiliates and an external CRO. With data coming from isolated teams across numerous language Download the PDF

Post-Market Advantage

Fri, 18 Jun 2010 15:57:25 -0400

Get 360-degree insight with an ally who knows you. Download the PDF

Targeting Oncology

Wed, 02 Jun 2010 15:36:02 -0400

Learn more about Quintiles leadership in oncology product development and commercialization. Download the PDF

Data-Driven Market Success

Fri, 14 May 2010 10:47:45 -0400

Steering the largest post-marketing diabetes study ever conducted, Quintiles was able to stay flexible and successfully scale up to an eight-country study with more than 55,000 patients, even with the operational challenges of multiple affiliates and staggered database locks. Download the PDF

The Right Balance

Wed, 31 Mar 2010 12:35:21 -0400

Through creative strategies and proactive measures, learn how Quintiles achieved both the recruitment targets and database lock eight months early. Download the PDF

PharmAsia News Article Reprint

Mon, 01 Mar 2010 09:21:33 -0400

Quintiles Asia Executives Say CROs Must Evaluate, Adjust To New Health Landscape: An Interview With PharmAsia News. Download the PDF

The Value of Reviewing Existing EU Risk Management Plans

Fri, 12 Feb 2010 09:33:12 -0400

Drug Safety experts Cheryl Key, Barry Mulchrone and Karen Wai describe an electronic database for tracking RMPs for drugs approved in the European Union and explain why it is crucial for sponsors submitting marketing applications to have a thorough knowledge of safety plans already required for similar products.

New FDA Guidance on Antidiabetic Therapies

Fri, 11 Dec 2009 06:00:00 -0400

Understanding the FDA Guidance on Assessing Cardiovascular Risks for new Antidiabetic Therapies. Learn what FDA cardiac safety requirements may mean for your development program.

Post-Market Advantage

Thu, 10 Dec 2009 18:09:23 -0400

As you plan your post-marketing research, you don’t have to look any further than the team that has worked with you in clinical development. While

Poster ISPOR EU - Health Related Quality of Life, EDSS and Timed Walk in MS

Thu, 03 Dec 2009 18:04:23 -0400

Poster ISPOR EU - Health Related Quality of Life, EDSS and Timed 25-foot Walk in a Multiple Sclerosis Population of a Real-World Observational Outcomes Study: Baseline Data from ROBUST Jeffery D, Kirzinger S, Halper J, Preblick R, Bi YJ, and Gemmen E., Quintiles Late Phase Download the PDF

The Role of Patient Registries in Evidence Development: Similarities and Difference Between Europe and North America

Mon, 30 Nov 2009 12:35:14 -0400

Presentations from ISPOR EU Workshop on The Role of Patient Registries in Evidence Development: Similarities and Difference Between Europe and North America Eric Gemmen, MA, Quintiles Late Phase Download the PDF

Indirect Social Cost of Multiple Sclerosis

Mon, 30 Nov 2009 11:55:13 -0400

ISPOR EU Presentation: Indirect Social Cost of Multiple Sclerosis Download the PDF

Association of Health-Related Quality of Life and Relapse in the Previous Year among Multiple Sclerosis Patients

Fri, 27 Nov 2009 23:56:46 -0400

Poster presentation. ISPOR EU 2009. Download the PDF

Early Phase Optimization Strategies

Wed, 18 Nov 2009 14:15:08 -0400

As payers balk at rising drug prices and patent expirations threaten the industry’s revenue streams, pharmaceutical companies worldwide are looking for ways to cut costs associated with drug development and, simultaneously, speed the process up. Download the PDF

Coordinating Safety Across Functions and Phases

Tue, 03 Nov 2009 17:43:07 -0400

Facing significant challenges with clinical and post-marketing safety, a customer needed an ally who could provide a full range of safety and risk management solutions. Download the PDF

What if You Could Expect More from Late Phase

Thu, 01 Oct 2009 16:49:25 -0400

Quintiles and Cerner share how you can get more from your late phase efforts. Download the PDF

QUINTILES AND CERNER WORK TOGETHER TO IMPROVE EFFICIENCY OF LATE PHASE RESEARCH STUDIES

Thu, 01 Oct 2009 16:21:56 -0400

October 1, 2009 – Global leaders in clinical research and electronic health record technology team up to streamline data collection and management.

Emerging Markets

Tue, 29 Sep 2009 18:42:09 -0400

If you’re looking for new ways to bring development costs down, you may be considering the advantages of conducting clinical trials in emerging markets.

QUINTILES INCREASES CAPACITY TO SUPPORT EUROPEAN CLINICAL TRIALS

Thu, 24 Sep 2009 11:39:33 -0400

September 24, 2009 - Quintiles Transnational Corp. announced the opening of an expanded regional facility near Edinburgh, Scotland; space for Quintiles Clinical Development Services, including Project Management, Regulatory Affairs and Data Management.

Podcast: Changing the Face of Cancer Research

Mon, 31 Aug 2009 12:13:18 -0400

Christopher Ung, Vice President, Strategic Business & Operations, Oncology, Quintiles, explains how advances in biomarker technology are ushering in a new era of cancer therapy development. Download the PDF

Podcast: Changing the Face of Cancer Research

Mon, 31 Aug 2009 12:13:18 -0400

Incremental Cost of Otitis Media Among Children in the United States

Thu, 25 Jun 2009 15:05:41 -0400

Using a nationally representative data source, the study estimates the medical cost of treating otitis media among children in the US. The costs are estimated at $2 billion in 2005. Download the PDF

Patient Registries: A Taxonomy for the Design, Development and Implementation

Thu, 25 Jun 2009 14:48:29 -0400

Recommendations from the ISPOR Patient Registry Classification, Strategy & Design Working Group, Team 2, for developing standard language for the characterization, classification, strategy, design, and execution of patient registries to generate data for outcomes research purposes. Download the PDF

Leveraging Patient-Reported Outcomes Prior to Comparative Effectiveness Studies

Thu, 18 Jun 2009 10:31:00 -0400

Leveraging Patient-Reported Outcome Methods to Test Hypotheses Prior to Initiating Comparative Effectiveness Studies Download the PDF

Early phase strategies

Mon, 15 Jun 2009 14:49:48 -0400

Web cast about Early Phase Strategies.

With so many CROs out there, which one is the best?

Fri, 05 Jun 2009 10:35:56 -0400

PharmaceuticalJobSite.com decided "to try and determine which is the best CRO....we have decided on which CRO we feel has the best overall reputation."

QUINTILES NAMED BEST CLINICAL SERVICE PROVIDER

Thu, 23 Apr 2009 11:12:39 -0400

April 23, 2009 - Quintiles was named by industry decision-makers as the most favored contract research organization (CRO), according to two recently released independent surveys.

Risk Mitigation Programs

Thu, 16 Apr 2009 14:54:05 -0400

Risk mitigation measures can help keep valuable drugs on the market, even when their safety profile includes adverse events that might negatively affect the benefit risk balance. Download the PDF

Risk Assessment & Strategy

Thu, 16 Apr 2009 14:42:55 -0400

Quintiles benefit risk analysis can help you anticipate potential regulatory concerns and highlight the benefit side of your drug’s benefit risk profile. Download the PDF

Phase IIIb/IV Studies

Thu, 16 Apr 2009 14:37:27 -0400

New, more efficient delivery models help meet the increasing demands of Phase IIIB/IV Studies. Download the PDF

Late Phase and Safety Services

Fri, 10 Apr 2009 14:59:09 -0400

Recent and pending regulatory changes have created an atmosphere of watchful waiting throughout the industry. While it may seem premature to initiate post-marketing studies to collect more “intelligent” safety data, Quintiles Late Phase & Safety Services anticipates that the need for expanded studies will soon spread. Download the PDF

Badania Kliniczne

Fri, 10 Apr 2009 10:11:23 -0400

Quintiles Poland świadczy usługi związane z organizacją i monitorowaniem Badań Klinicznych faz I-IV. Każdy nowy lek - zanim będzie dostępny w sprzedaży- musi przejść fazę wszechstronnych, specjalistycznych testów i uzyskać aprobatę organów rejestracyjnych.

Championing the Clinical Trial

Tue, 31 Mar 2009 16:06:10 -0400

Quintiles’ ethical standards and review procedures ensure patient safety remains the top priority for all clinical trials. The company is also leading the way for data transparency, so drug trial sponsors have instant access to information about the conduct and status of trials. Download the PDF

Hungary

Fri, 27 Mar 2009 13:19:01 -0400

A Quintiles 1998 óta mûködik Magyarországon. Tagja a világ legnagyobb, legsikeresebb klinikai kutatási szerzõdéses vállalatcsoportjának, a Quintiles Transnational-nek. A Quintiles Transnational több mint 19.000 alkalmazottat foglalkoztat a világ több mint 50 országában.

Quintiles Poland

Fri, 27 Mar 2009 13:14:17 -0400

Quintiles działa na polskim rynku od 1996 roku zajmując się organizacją i monitorowaniem badań klinicznych. Jest częścią międzynarodowej korporacji Quintiles Transnational - największej i najstarszej Kontraktowej Organizacji Badawczej z siedzibą w Stanach Zjednoczonych. Quintiles Transnational zatrudnia ponad 19 000 osób w ponad 50 krajach na całym świecie.

Blended Site Monitoring

Fri, 27 Mar 2009 13:11:38 -0400

Quintiles Project Coordination Centers provide centralized support to investigators and sites in collaboration with traditional on-site staff (CRAs). Download the PDF

Accelerating a Trial Delayed by Slow Approvals

Fri, 27 Mar 2009 13:08:36 -0400

Intense remote monitoring by project coordination center quickly speeds up recruitment Download the PDF

Finland

Fri, 27 Mar 2009 13:01:18 -0400

Quintiles on maailman johtava lääketutkimuksen ja –markkinoinnin sopimusyhtiö, jonka palveluksessa on maailmanlaajuisesti lähes 23 000 työntekijää. Espoon Pohjois-Tapiolassa sijaitseva Quintiles Oy on yhdysvaltalaisen Quintiles Transnational Corp.:n tytäryhtiö ja toimistomme on palvellut lääkeyrityksiä Suomessa jo vuodesta 1995 lähtien. Palvelemme sekä pieniä kotimaisia lääkealan biotekniikkayrityksiä että suuria kansainvälisiä lääkeyrityksiä. Quintiles Oy on koordinoinut tähän mennessä satoja kliinistä tutkimuksia, jotka kattavat kaikki tärkeimmät terapia-alueet.

Welcome to Quintiles Transnational Korea

Fri, 27 Mar 2009 12:06:22 -0400

퀸타일즈는 “고객의 가치를 창조하는 신뢰할 수 있는 서비스 파트너”로서, 신약개발에 대한 토탈 솔루션을 제공합니다. 따라서 고객은 모든 영역에 걸쳐서, 혹은 기업내부의 특정 요구에 맞는 서비스를 선택할 수 있습니다. 퀸타일즈는 전 세계 50 여 개국에서 활동하고

How to Navigate the New CDISC Standard

Wed, 25 Mar 2009 16:59:07 -0400

Quintiles – a CDISC Registered Solutions Provider – helps you get every detail right. Download the PDF

Antibiotic Safety Assessment

Wed, 25 Mar 2009 10:53:22 -0400

A major pharmaceutical company presented Quintiles with a pressing challenge – to collect extensive amounts of Phase IV data in compressed time windows because the treatment conditions were subject to seasonal variants.

The Art and Science of Project Management

Mon, 01 Jan 2007 10:44:48 -0400

The success of any project depends on lining up the right resources, in the right combination, at precisely the right time. Quintiles Project Managers take a rigorously scientific approach to the “arts” of staffing, troubleshooting and risk management.