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

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

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

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

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.

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.

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

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

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

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

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

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

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

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.

SCDM 2012

Thu, 12 Jan 2012 11:40:37 -0400

Quintiles will have an exhibit

DIA US 2012

Thu, 12 Jan 2012 11:06:15 -0400

Quintiles will have an exhibit

Using Real-time Data to Drive Better Decisions, Faster

Thu, 12 Jan 2012 09:11:45 -0400

This article examines the advantages afforded by access to real-time data during the course of a clinical trial.

ASCO 2012 – Accelerating Investigator Success in Oncology Trials

Wed, 11 Jan 2012 17:33:31 -0400

Quintiles will have an exhibit

Quintiles Infosario Lifecycle Safety System Fact Sheet

Wed, 21 Dec 2011 11:14:22 -0400

A comprehensive, cloud-based safety management system that increases customers agility and maximizes cost efficiency. A system designed to manage all safety activities across all programs, Download the PDF

Intarcia and Quintiles Finalize Innovative Alliance

Tue, 13 Dec 2011 07:43:17 -0400

December 13, 2011 – To speed development of a potential ground-breaking therapy for Type 2 diabetes – Intarcia Therapeutics, Inc., and Quintiles announced the signing of definitive agreements making Quintiles a financial and strategic partner for the global clinical development of Intarcia’s ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide).

Quintiles Launches China CRO, Kun Tuo

Tue, 13 Dec 2011 07:01:52 -0400

December 13, 2011 – Further deepening its commitment to China, Quintiles announced the launch of Kun Tuo, a local contract research organization (CRO) built to service the unique needs of the Chinese biopharmaceutical industry and multinational biopharma companies operating in China.

Harish Dave Discusses ASH 2011

Thu, 08 Dec 2011 14:16:12 -0400

Harish Dave discusses the American Society of Hematology annual meeting.

Sustainable Compliance Begins with a Strong Foundation

Thu, 08 Dec 2011 13:49:28 -0400

The urgency of a problem often entices people to quickly focus on finding a solution and repairing the problem in order to immediately remedy the situation. Download the PDF

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

Tue, 06 Dec 2011 15:08:43 -0400

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

Quintiles Expands World's Largest Cap-Accredited Lab Network

Thu, 01 Dec 2011 08:00:00 -0400

December 1, 2011 – Continuing the expansion of its Global Laboratories’ capabilities and resources, Quintiles announced the opening of a new, expanded central lab in Centurion, South Africa.

Quintiles and Prodia Partner to Provide Central Lab Testing Solution in Indonesia

Wed, 30 Nov 2011 02:00:00 -0400

November 30, 2011 – Quintiles announced an expanded partnership with Jakarta-based Prodia Clinical Laboratory, through its sister company Prodia the CRO, to facilitate rapid testing of samples from patients in clinical trials in Indonesia.

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

Re-ignite Product Development and Sales with Data Insights: Fueling Innovation Fact Sheet

Thu, 17 Nov 2011 12:54:17 -0400

What Will Drive Biopharma’s Future? The long-dreaded crisis is staring us all in the face: What will take the place of expiring blockbusters with few prospects in hand? Spending on R&D more than doubled after 2002, but the output doesn’t match the investment. The number of new molecular entities has remained a disappointment, averaging only around 20 per year in the US. The big question is how can drug developers carve out a strategic path to innovation? Download the PDF

Quintiles Completes Acquisition of Advion BioServices

Mon, 07 Nov 2011 06:00:00 -0400

November 7, 2011 – Quintiles’ ability to provide customers with actionable early-stage data to make better development decisions faster has taken a significant step forward with the closing of the previously announced agreement to acquire Advion BioServices, a premier U.S.-based bioanalytical laboratory.

Quintiles Agrees to Acquire Premier GLP Bioanalytics Laboratory

Wed, 26 Oct 2011 09:03:53 -0400

October 26, 2011 – To provide a more comprehensive and efficient global solution for its laboratory customers, Quintiles signed of a definitive agreement to acquire Advion BioServices.

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).

Podcast: Global Biosimilars Outlook

Tue, 11 Oct 2011 11:50:16 -0400

Dr. Amar Kureishi, Regional Chief Medical Officer, Asia-Pacific, Quintiles, discusses the main drivers behind the growth of biosimilars, and offers suggestions for biopharmaceutical companies looking to enter the space.

Clinical Evaluation Medical Devices

Thu, 06 Oct 2011 09:17:44 -0400

A Clinical Evaluation Report (CER) is a living document required for all classes of new and existing products within the EU, detailing the clinical evaluation of a product throughout its life-cycle. Additional focus has been placed on clinical evaluations since changes in the Medical Devices Directive [“MDD”]1 have come into force in March 2010. A renewed focus by Notified Bodies on clinical evaluations, against the updated legislation, has led to a number of audit observations against manufacturers with regard to CER’s containing insufficient clinical data, or manufacturers not holding product CER’s. Download the PDF

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.

Creating Metadata-Driven Program Logic

Tue, 04 Oct 2011 14:25:45 -0400

This paper presents a solution in which a DATA step is used to access CTC grading logic metadata and the CALL EXECUTE routine is used to place the associated SAS® statements in the SAS command stack for execution after the DATA step has finished. This process creates a virtual DATA step that will assign the CTC grades to each observation in the laboratory results data set. Download the PDF

Energizing Enrollment

Tue, 04 Oct 2011 14:22:38 -0400

The rapid recruitment for this Phase III, open, randomized, controlled, multi-center study in adjuvant triple-negative breast cancer (TNBC) was completed two months earlier than planned. Download the PDF

Model-Based Drug Development

Tue, 04 Oct 2011 12:52:59 -0400

Our industry-leading model-based drug development services boost the probability of success in the New Health by enabling you to make critical decisions earlier, optimizing your resources and returns. Download the PDF

Quintiles Addresses Key Considerations for Successful Biosimilar Development

Fri, 30 Sep 2011 14:53:19 -0400

September 29, 2011 – Regulatory and commercial considerations are the primary drivers for successful biosimilar development, according to a new report from Quintiles.

Fuzzy Merges - A Guide to Joining Datasets with Non-Exact Keys Using SAS Proc SQL

Fri, 30 Sep 2011 13:17:57 -0400

Robert W. Graebner put forth a paper discussing "Fuzzy Merges - A Guide to Joining Datasets with Non-Exact Keys Using SAS Proc SQL" at the Download the PDF

Podcast: Real-time Data and Patient Safety

Fri, 30 Sep 2011 06:02:01 -0400

Andrew Garrett, Global Head of Biostatistics, Medical Writing and Regulatory Affairs for Quintiles, discusses how real-time collection of clinical research data can accelerate development timelines and better ensure patient safety.

Podcast: Strategic Considerations for Biosimilar Development & Commercialization

Fri, 30 Sep 2011 05:11:50 -0400

Deepa Dahal, Principal Consultant, Consulting at Quintiles, and Dr. Nigel Rulewski, Vice President of Global Strategic Drug Development, emphasize an integrated approach to biosimilar development and commercialization.

An Integrated Approach to Biosimilar Development & Commercialization

Thu, 29 Sep 2011 00:00:00 -0400

As the market for biosimilar products continues to grow, many biopharmaceutical companies trying to enter the space are struggling to overcome the unique challenges that developing such products presents. Download the PDF

Partnering is Key to Maximizing Rewards in Emerging Markets

Tue, 27 Sep 2011 06:00:00 -0400

September 27, 2011 – While biopharmaceutical spending in emerging markets is growing at double-digit rates – much faster than in developed nations – opportunities in “pharmerging” countries must be balanced with accompanying costs and risks of entering new markets.

Web-based ePRO Tools and Post-Marketing Studies

Mon, 26 Sep 2011 13:07:04 -0400

Eric Gemmen discusses "Web-based ePRO Tools and Post-Marketing Studies" with Scott Dixon from Oracle Health Sciences at the Society for Clinical Data Management, September 11-14, Download the PDF

Off-Shoring - From Tactical to Strategic

Thu, 22 Sep 2011 17:13:31 -0400

Richard Cesarski and Michael Fiola discuss "Off-Shoring - From Tactical to Strategic" at the Society for Clinical Data Management, September 11-14, 2011 in Baltimore, MD, Download the PDF

Beyond Tables and P-values: Enhancing the Role of the Clinical Trial Team Statistician

Thu, 22 Sep 2011 17:04:33 -0400

Sonia Davis discusses "Beyond Tables and P-values: Enhancing the Role of the Clinical Trial Team Statistician" at the FDA/Industry Statistics Workshop, on September 20, 2011. Download the PDF

Development of CDISC Tuberculosis Data Standards

Thu, 22 Sep 2011 16:51:10 -0400

Michael Fiola discusses "Development of CDISC Tuberculosis Data Standards" at the Society for Clinical Data Management, September 11-14, 2011 in Baltimore, MD, US. Download the PDF

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

Quintiles Recognized as One of The Best Technology Innovators & Industry Leaders by InformationWeek

Wed, 14 Sep 2011 08:50:37 -0400

September 14, 2011 – Quintiles was named 4th in the prestigious InformationWeek 500 technology innovators rankings for its Quintiles INFOSARIO™ platform. The company was also recognized as the industry leader in the biotech and pharmaceutical category.

Polish Pharmaceutical and Healthcare Sector

Fri, 09 Sep 2011 16:43:09 -0400

To say ‘Sleeping Giant’ about Poland is no longer true claims Wojciech Przybys, VP EMEA and provides a deeper analysis of the polish clinical research Download the PDF

Shifting Sands

Fri, 02 Sep 2011 09:40:47 -0400

As the pressure to improve the productivity of clinical development programmes mounts on pharmaceutical companies, the current landscape for locating cost-effective clinical trials continues to evolve. One region attracting attention is the Middle East and North Africa. Download the PDF

Quintiles Appoints Global Head of Phase I Division

Wed, 31 Aug 2011 09:00:00 -0400

August 31, 2011 – Quintiles announced that Oren Cohen, M.D., will serve as Senior Vice President and Global Head of its Phase I Clinical Research division, which includes world-class facilities in Overland Park, Kansas (U.S.), London (U.K.) and Hyderabad (India).

Blind Review of Planned Analyses for Clinical Trials

Wed, 17 Aug 2011 13:55:52 -0400

Lan Liu and John Schollenberger discuss "Blind Review of Planned Analyses for Clinical Trials" at the 2011 Joint Statistical Meetings, July - August 2011 in Download the PDF

Sample Size Estimation For Drug Combination In Fixed Dose Trials

Wed, 17 Aug 2011 13:39:56 -0400

Jie Wang, PhD, discusses "Sample Size Estimation For Drug Combination In Fixed Dose Trials" at the 2011 Joint Statistical Meetings, July - August 2011 in Download the PDF

Make Smarter Choices

Fri, 22 Jul 2011 13:42:06 -0400

In your world, every grain of data matters — and every minute counts. To make the most of what you’ve got, turn to Model-Based Drug Development.

Optimizing Type II Diabetes Drug Development

Thu, 21 Jul 2011 10:48:19 -0400

Zoran Antonijevic discusses "Optimizing Type II Diabetes Drug Development" at the DIA 2011 47th Annual Meeting in Chicago, IL, US. Download the PDF

Using Regulatory Guidance to Get Credible Results with Missing Data

Thu, 21 Jul 2011 10:43:31 -0400

Michael O'Kelly discusses "Using Regulatory Guidance to Get Credible Results with Missing Data" at the DIA 2011 47th Annual Meeting in Chicago, IL, US. 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

Clinical Trial Educators

Wed, 06 Jul 2011 10:12:44 -0400

Stewart Rosen discusses the role of Clinical Trial Educators in Enrollment and Retention.

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

Quintiles Infosario - 30 Seconds

Sun, 26 Jun 2011 18:54:33 -0400

Quintiles Infosario™ delivers this and so much more. A comprehensive new suite of services, Quintiles Infosario seamlessly integrates data, systems, processes and expertise to help

Quintiles Infosario

Sun, 26 Jun 2011 17:24:10 -0400

Quintiles Infosario™ delivers this and so much more. A comprehensive new suite of services, Quintiles Infosario seamlessly integrates data, systems, processes and expertise to help

Australia and New Zealand Phase II/III Fact Sheet

Fri, 24 Jun 2011 15:53:36 -0400

Australia and New Zealand fact sheet around Phase II/III trials. Same language. Same technology. Same quality standards. Download the PDF

Off-Season Pediatric Enrollment

Fri, 24 Jun 2011 15:32:02 -0400

This sponsor needed to conduct a pediatric influenza during the off-season months of March - May. Quintiles completed enrollment and database lock ahead of schedule. Download the PDF

Malaria Prevention in Sub-Saharan Africa

Fri, 24 Jun 2011 14:30:30 -0400

This study enabled us to be involved in bringing a malaria vaccine to Africa which could substantially reduce an infant mortality rate that currently stands Download the PDF

The Molecular Biomarker Revolution in Non-Small Cell Lung Cancer

Thu, 23 Jun 2011 14:33:45 -0400

In this new white paper Quintiles’ experts Christopher Ung, Jason Hill, Carrie Lee and Harish Dave review some of the most promising molecular pathways and targeted approaches for NSCLC, the critical role of diagnostics, and strategies to detect and address the emergence of resistance. Download the PDF

Digital Pathology Central Laboratory Services Fact Sheet

Thu, 23 Jun 2011 14:23:15 -0400

This fact sheet highlights Quintiles' digital pathology services, covering everything from scanning of slides to review and analysis - giving you a faster, easier way to scan and share this critical research data. Download the PDF

Quintiles Wins Best CRO in Vaccine Excellence Asia Awards 2011

Thu, 23 Jun 2011 12:04:45 -0400

June 23, 2011 – Quintiles, a leading global biopharmaceutical services company, today announced that it has been named Best Clinical Research Organization (CRO) in the Vaccine Industry Excellence (ViE) Asia Awards 2011.

Genomics Fact Sheet

Fri, 17 Jun 2011 15:45:36 -0400

Approximately 20% of today’s U.S. Clinical Trials use genomic technology. Find out about Quintiles’ offerings in this area. Download the PDF

Lean Sigma in the New Health Landscape: An Application in Biostatistics (Poster)

Wed, 15 Jun 2011 10:59:33 -0400

Tim Strauss, Emma Bickford and Josie Measures developed a poster on Lean Sigma in the New Health Landscape: An Application in Biostatistics for the PSI Conference Download the PDF

Tutorial on ICH E9 and Other Statistical Regulatory Guidance (Part 2)

Wed, 15 Jun 2011 10:50:42 -0400

Kerry Gordon gave a statistical regulatoy guidance tutorial on ICH E9 and E10 at the PSI Conference in May 2011. This is part 2 of his Download the PDF

Tutorial on ICH E9 and Other Statistical Regulatory Guidance (Part 1)

Wed, 15 Jun 2011 10:42:28 -0400

Kerry Gordon gave a statistical regulatoy guidance tutorial on ICH E9 and E10 at the PSI Conference in May 2011. This is part 1 of his session. Download the PDF

Lean Sigma in the New Health Landscape: An Application in Biostatistics

Wed, 15 Jun 2011 10:33:12 -0400

Tim Strauss, Emma Bickford and Josie Measures discussed Lean Sigma in the New Health Landscape: An Application in Biostatistics at the 32nd Annual Society for Download the PDF

Quintiles Infosario

Fri, 10 Jun 2011 15:46:53 -0400

Quintiles Infosario™ is a new, comprehensive suite of services that enables optimized drug development. Download the PDF

Quintiles Appoints New Head of Late Phase Operations

Thu, 09 Jun 2011 09:19:39 -0400

June 9, 2011 – Quintiles announced the appointment of Dr. Cynthia L. Verst as Global Head of Late Phase Operations.

Systems as a Service

Fri, 03 Jun 2011 13:31:56 -0400

Quintiles Infosario™ Systems as a Service gives you access to our best-of-breed commercial platforms and proprietary technologies, augmented by Quintiles’ leading clinical expertise.

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.

Translational R&D Services Fact Sheet

Thu, 26 May 2011 17:45:56 -0400

Quintiles’ Translational R&D Center of Excellence performs groundbreaking research and offers novel findings in oncology for biopharmaceutical companies. Download the PDF

Quintiles Names Rick Sax New Head of Integrated Clinical Services

Mon, 23 May 2011 09:30:00 -0400

May 23, 2011 – Quintiles announced the appointment of Frederic “Rick” Sax as Senior Vice President and Global Head of its Integrated Clinical Services division.rograms.

Quintiles and Population Genetics Technologies Partner

Mon, 16 May 2011 00:00:00 -0400

May 16, 2011 – Quintiles, and Population Genetics Technologies Ltd. (PGT), announced a commercial collaboration to bring genomic testing into mainstream drug development in order to produce safer, more effective medicines.

Dr. Frank Massam

Fri, 13 May 2011 22:01:05 -0400

Dr. Frank Massam discusses the significance of Quintiles' partnership with Population Genetics Technologies Ltd.

Creating Customized Patient Profiles using SAS ODS RTF and PROC TEMPLATE

Thu, 12 May 2011 11:20:13 -0400

In this article for PharmaSUG 2011, May 8-11 in Nashville, Tennessee, Andrea Ritter discusses producing patient profiles using SAS® PROC TEMPLATE table definitions and the Output Delivery System Download the PDF

Implementation of Pattern-Mixture Models Using Standard SAS/STAT Procedures

Thu, 12 May 2011 10:57:13 -0400

In this article for PharmaSUG 2011, May 8-11 in Nashville, Tennessee, Bohdana Ratitch and Michael O'Kelly discuss Implementation of Pattern-Mixture Models Using Standard SAS/STAT Procedures. Download the PDF

Asia-Pacific Expertise

Wed, 11 May 2011 13:06:56 -0400

Quintiles' experience and flexibility to understand cultural and communication differences across Asia Pacific provided an integrated solution which exceeded recruitment targets. Download the PDF

CardioCheck

Tue, 10 May 2011 12:19:07 -0400

Quintiles' CardioCheck program is designed to provide rapid insight into potential cardiotoxic influences of pharmaceutical compounds. Download the PDF

The Impact of Globalization on the Statistical Services

Wed, 20 Apr 2011 11:27:06 -0400

Jorgen Seldrup was a discussant in a session on "The Impact of Globalization on the Statistical Services" at the ISBS/EMA/IBS-DR Joint Conference in Berlin on Download the PDF

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.

Mixed models and Missing Data in Practice

Wed, 13 Apr 2011 14:14:25 -0400

Michael O'Kelly discusses the usage of mixed models to handle missing data in your clinical trial at the ISBS/EMA/IBS-DR Joint Conference in Berlin on March Download the PDF

Examples of Using Modelling and Simulation in Getting Treatments to Market

Wed, 13 Apr 2011 14:07:01 -0400

Michael O'Kelly discusses modelling and simulation, including examples of use for getting treatments to market at the ISBS/EMA/IBS-DR Joint Conference in Berlin on March 1, 2011. Download the PDF

Mixed Models for Data from Thorough QT Studies

Wed, 13 Apr 2011 14:01:09 -0400

Robert Schall and Arne Ring discuss a one-step assessment of conditional QT prolongation at the ISBS/EMA/IBS-DR Joint Conference in Berlin on March 1, 2011. Download the PDF

Regional Regulatory Non-inferiority Guidances and Beyond

Wed, 13 Apr 2011 13:48:20 -0400

Jorgen Seldrup discusses discounting and pooling in non-inferiority trials at the ISBS/EMA/IBS-DR Joint Conference in Berlin on March 1, 2011. Download the PDF

Whatever Happened to Harmonisation?

Wed, 13 Apr 2011 13:36:20 -0400

Jorgen Seldrup discusses the concept of harmonized drug development at the ISBS/EMA/IBS-DR Joint Conference in Berlin on March 1, 2011. Download the PDF

Value Based Drug Development

Wed, 13 Apr 2011 13:20:05 -0400

Zoran Antonijevic discusses assessing the value of your product portfolio and the need for an integrated approach between commercialization and R&D at ISBS. Download the PDF

Advancing Vaccine Development in Australia and New Zealand

Mon, 11 Apr 2011 15:25:59 -0400

Quintiles rose to the challenge of a very aggressive vaccine recruitment timeline during the holiday period - and recruited 3,000+ subjects from 18-90 years of age within just 17 days - 25 days ahead of schedule.

Quintiles Reaches New Milestone in Social Health

Mon, 28 Mar 2011 14:07:47 -0400

March 28, 2011 – Quintiles announced that its online social community at www.MediGuard.org has reached 2.5 million members in just three years.

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.

Podcast: MediGuard's Membership Milestone

Fri, 25 Mar 2011 16:10:43 -0400

Hugo Stephenson, President of MediGuard, dicusses the 2.5 million member milestone.

Biomarkers in Alzheimers Disease

Thu, 17 Mar 2011 09:06:55 -0400

The Quintiles Innovation Unit shares their knowledge on the use of biomarkers in compound development in clinical trials. Download the PDF

Constant Vigilance

Wed, 16 Mar 2011 13:31:46 -0400

Centralized planning played a key role in improving productivity during site visits and close monitoring ensured the high standards Quintiles put in place were met. Download the PDF

Recruiting Trust

Wed, 16 Mar 2011 13:21:22 -0400

Quintiles enrolls 2 cancer trials, 2 times faster than projected Download the PDF

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.

Quintiles Central Laboratory Awarded Accreditation to the International Standard for Quality Management

Wed, 23 Feb 2011 09:50:01 -0400

February 23, 2011 – Quintiles lab is one of only of a limited number of central labs in the U.S. to meet the rigorous requirements for medical laboratory quality and competence established by the International Organization for Standardization (ISO).

The US Approval Pathway for Biosimilar Products

Tue, 22 Feb 2011 13:51:36 -0400

The Public Health Service Act allows biosimilars in the US. The law incorporates a specific subsection dealing with biosimilars entitled the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Download the PDF

Clinical Endpoint Committees

Tue, 22 Feb 2011 09:04:10 -0400

As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs.

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

Diabetes and Biomarkers

Tue, 15 Feb 2011 13:58:22 -0400

The landscape is changing. Where do biomarkers fit in? Discover the current implications and challenges with biomarkers in the development of your diabetes portfolio in this peer reviewed commentary. 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

Scientific Bulletin Flow Cytometry

Wed, 09 Feb 2011 16:46:16 -0400

Quintiles has expertise in running highly regulated flow cytometry assays, as well as a number of esoteric assays, such as multicolor cell surface and intracellular staining assays, and receptor occupancy/competitive binding assays. Download the PDF

Competitive Edge - Ulcerative Colitis

Wed, 02 Feb 2011 15:47:02 -0400

Although faced with the challenge of recruiting for this small patient population, enrollment was completed two months ahead of schedule. 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

Proven Precision

Wed, 02 Feb 2011 13:55:39 -0400

Quintiles brings together – under a dedicated project manager – incredibly talented regulatory strategists, medical writers, biostatisticians, and medical, publishing and clinical pharmacology specialists who work closely together to design and implement efficient, effective submissions from beginning to end. Download the PDF

25 Years of Regulation - and Still Failing - Risky Business, Chapter 4

Wed, 02 Feb 2011 13:54:35 -0400

Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness. Download the PDF

Superior Teamwork - Renal Transplants

Wed, 02 Feb 2011 11:42:00 -0400

901 patients were randomized according to the protocol timelines. The database lock was achieved 11 days before the original target date. Download the PDF

Timely Results - Flu Vaccine

Wed, 02 Feb 2011 11:32:53 -0400

Streamlined processes for study startup, coupled with experience in vaccine trials and solid relationships with study sites and investigators, helped this Quintiles team meet the challenge of starting an influenza vaccine trial late in the influenza season.

Bypassing Barriers - Refractory Partial Epilepsy

Wed, 02 Feb 2011 11:24:17 -0400

Despite a difficult and limited patient population, Quintiles randomized 388 patients (13 over target) 10 weeks ahead of schedule. Download the PDF

Quintiles Websites Empower Patients

Tue, 01 Feb 2011 16:47:37 -0400

February 1, 2011 – Quintiles’ ClinicalResearch.com and MediGuard.org websites have been honored by the prestigious Web Health Awards for empowering patients to make better informed health decisions.

Diabetes - Therapeutic Focus

Tue, 01 Feb 2011 14:12:57 -0400

A dose-ranging clinical study to evaluate the safety, efficacy and tolerability of five doses of Drug X compared with placebo in Type II diabetes patients with no prior exposure to anti-diabetic medication. Download the PDF

Parkinson's Disease - Ambitious Recruitment

Tue, 01 Feb 2011 14:08:28 -0400

Quintiles provided project management, clinical monitoring, and more for a study of a drug for patients with early stage idiopathic Parkinson’s disease. Download the PDF

H1N1 - Proactive Engagement

Tue, 01 Feb 2011 14:06:59 -0400

Despite short timelines and government requirements, an H1N1 vaccine study finished in time for the influenza season. Download the PDF

Epilepsy - Refining Recruitment

Tue, 01 Feb 2011 14:04:52 -0400

Quintiles provided clinical monitoring and project management for a randomized, double-blind, parallel-group, placebo and comparator controlled multicenter study of Drug X in patients with epilepsy. Download the PDF

Global Response HIV

Tue, 01 Feb 2011 13:56:18 -0400

Due to its global reach and extensive experience, Quintiles successfully managed 830 sites in 32 countries and recruited 14,521 patients. Download the PDF

A Lock on Consistency

Tue, 01 Feb 2011 13:39:45 -0400

A double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of eplerenone in patients with heart failure following acute myocardial infarction. Download the PDF

Promoting Prevention

Tue, 01 Feb 2011 13:37:46 -0400

How do you recruit for an influenza vaccine trial off-season? Quintiles tapped our Partner Sites and completed enrollment in just four days. Download the PDF

Acute Coronary Syndrome - Tailored Solutions

Tue, 01 Feb 2011 13:22:42 -0400

Find out how our experience in multi-national cardiovascular clinical trials helped this customer reach database lock 66 days after LPO. Download the PDF

Deploying Clinical Trial Educators to Increase Clinical Trial Recruitment

Tue, 01 Feb 2011 11:16:58 -0400

In the February 2011 issue of the ACRP Monitor experts from Quintiles explain the importance of Clinical Trial Educators (CTEs) and their role in clinical Download the PDF

Oncology Expertise - Scientific Collaborator for Global Solutions

Fri, 28 Jan 2011 10:01:54 -0400

Whether you wish to use one of our existing assays, need assistance with developing a new assay, or plan to deploy an assay developed by your diagnostic partner, as your collaborator, Quintiles has the scientific expertise, resources, and flexibility to develop the right solution for you. Download the PDF

Securing Compliance

Thu, 27 Jan 2011 17:15:48 -0400

Our customer trusted Quintiles to handle the entire project, and – equally important – to ensure timely delivery. Download the PDF

Quintiles Speeds Early-Phase Decision Making with New Unit in Hyderabad, India

Mon, 24 Jan 2011 08:52:51 -0400

January 24, 2011 – Quintiles officially opened its new Phase I research facility in Hyderabad, India at Apollo Health City.

QUINTILES, LONDON GENETICS ALLY TO ENHANCE DRUG DISCOVERY AND DEVELOPMENT THROUGH PHARMACOGENETICS

Mon, 29 Nov 2010 09:00:00 -0400

November 29, 2010 – Quintiles, London Genetics alliance combines world-class expertise, global infrastructure to support biopharma in developing personalized medicine.

Flexible Capacity

Wed, 24 Nov 2010 11:25:36 -0400

Working with an ally who could deliver process efficiencies and cost-savings on a global scale, this company was able to expand its global portfolio. Download the PDF

Global Pharmacovigilance learn from African Experience

Tue, 23 Nov 2010 12:26:07 -0400

Prof. Oppel Greeff's presentation at ISoP 2010 on "How can global pharmacovigilance learn from the African Experience". 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

The African Approach to Risk Management

Tue, 23 Nov 2010 11:30:04 -0400

Professor Oppel Greef's Presentation on the African Approach to Risk Management in South Africa during the 2010 ISoP conference. Download the PDF

2010 Executive Vision Forum Insight Report

Thu, 18 Nov 2010 11:43:48 -0400

The 2010 forum presented a venue for executives and key opinion leaders to discuss and debate the converging forces now reshaping the industry.

Beijing, China Central Laboratory Services Fact Sheet

Wed, 17 Nov 2010 10:36:20 -0400

This fact sheet demonstrates Quintiles long history of supporting clinical trials in China, including a constantly expanding list of services. Download the PDF

BIOMODA SELECTS QUINTILES TO HELP DEVELOP MORE ACCURATE AUTOMATED SYSTEM FOR DETECTING EARLY-STAGE LUNG CANCER

Mon, 15 Nov 2010 09:00:00 -0400

November 15, 2010 – Cancer diagnostics company Biomoda, Inc. has allied with Quintiles' Central Laboratories to help refine the automated image recognition system for measuring the photon emission rate and cell morphology of CyPath®-stained cells to detect early stage lung cancer.

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.

Data Management Solutions: Faster Access to Reliable Clinical Trial Data

Mon, 08 Nov 2010 12:51:30 -0400

Quintiles is your ally for navigating the complexities of clinical trial management. Our flexible solutions meet your need for speed, without compromising data integrity or accuracy. Download the PDF

Healthcare's Future Tools

Mon, 08 Nov 2010 11:22:22 -0400

Beyond Genomics. The knowledge gained in mapping the genome is producing more tools and new ways of understanding how the human body works. See what's in store in this exclusive report.

Oncology Drug Development and Value-Based Medicine

Fri, 05 Nov 2010 14:57:57 -0400

This report demonstrates the need to converge clinical and commercial imperatives earlier within the drug development process to meet a future demand for value-based medical practices. Download the PDF

MediGuard

Tue, 02 Nov 2010 12:10:40 -0400

MediGuard presentation at AusBiotech 2010 Download the PDF

The Changing Landscape of Pharma - Tilt to Asia

Tue, 02 Nov 2010 11:57:51 -0400

Amar Kureishi's presentation "The Changing Landscape of Pharma - Tilt to Asia" at AusBiotech 2010 Download the PDF

Pharmacobiomics and Infectious Disease: Progress and Opportunities

Tue, 02 Nov 2010 08:35:43 -0400

Pharmacobiomics and Infectious Disease: Progress Opportunities. After decades of work mapping the human genome, we are beginning to reap real benefits. Download the PDF

DAKO AND QUINTILES FORM ALLIANCE TO SPEED DEVELOPMENT OF PERSONALIZED MEDICINE

Mon, 01 Nov 2010 09:00:00 -0400

November 1, 2010 - Dako and Quintiles announced a strategic alliance to advance personalized medicine by collaborating on the co-development of targeted therapies and companion diagnostics.

Podcast: Clinical Development of Cancer Drugs in China

Mon, 18 Oct 2010 11:34:18 -0400

Hear exclusive interviews with Quintiles's experts, Christopher Ung, Patty James and Harish Dave on their recent participation at the 13th Annual Chinese Society of Clinical Oncology

From Biomarkers to Diagnostics - The Road to Success

Mon, 18 Oct 2010 10:43:12 -0400

In the second installment of a two-part series, Eric Groves, Jason Hill and Christopher Ung walk through the challenges associated with drug-diagnostic co-development, addressing potential pitfalls and areas of opportunity. Download the PDF

Advancing Clinical Research in Alzheimer's Disease

Mon, 18 Oct 2010 10:13:05 -0400

This report from Quintiles’ own Alzheimer’s experts gives you an inside look at the news from ICAD 2010. Download the PDF

Scientific Bulletin PI3K Biomarker Assay

Fri, 15 Oct 2010 17:23:37 -0400

This PI3K Biomarker Assay scientific bulletin reviews test highlights, disease overview and testing methodology. Download the PDF

Data Transfer Express

Wed, 13 Oct 2010 13:38:41 -0400

An innovative solution to the challenging data transfer requirements of Eli Lilly. Download the PDF

EXAMINING REAL-TIME DATA TO IMPROVE THE QUALITY AND EFFICIENCY OF DRUG DEVELOPMENT

Wed, 13 Oct 2010 06:00:00 -0400

October 13, 2010 – White Paper authors explore how real-time data can enhance patient safety, strengthen quality and accelerate development timelines.

QUINTILES TO BE KEY PARTICIPANT AT SOCIETY FOR CLINICAL DATA MANAGEMENT ANNUAL CONFERENCE

Tue, 12 Oct 2010 08:42:03 -0400

October 12, 2010 - Quintiles’ Paula Brown Stafford, President, Clinical Development will open the conference with a keynote speech on the evolution from data management to information management.

The Art and Science of Segmentation

Sat, 09 Oct 2010 09:19:26 -0400

Quintiles presentation delivers fresh insights into the art and science of segmentation and its practical applications in market research. The presentation features a key Pfizer case study.

Is a REMS Request from FDA More Likely for Drugs & Biologics Indicated for Pediatric Use?

Fri, 08 Oct 2010 08:15:13 -0400

Is a REMS Request From FDA More Likely For Drugs and Biologics Indicated for Pediatric Use?

QUINTILES PARTNERS WITH THE SEOUL NATIONAL UNIVERSITY HOSPITAL

Wed, 06 Oct 2010 12:00:00 -0400

October 6, 2010 – Quintiles celebrates its 10th year anniversary in South Korea by announcing a strategic alliance with the Seoul National University Hospital (SNUH) as part of its unique Prime Site program.

Responding to FDA Enforcement

Tue, 05 Oct 2010 16:31:31 -0400

As the FDA ratchets up its enforcement actions, pharmaceutical and medical device companies are turning to Quintiles. Learn what differentiates our consulting solutions. Download the PDF

Management of Tissue Specimens for Oncology Drug Development in China

Fri, 01 Oct 2010 11:07:10 -0400

Download Patty James of Quintiles recent presentation Management of Tissue Specimens for Oncology Drug Development in China from the Clinical Development of Cancer Drugs in China

Outsourcing Oncology Molecular Biomarkers - Considerations for Emerging Countries

Fri, 01 Oct 2010 10:58:33 -0400

Download Christopher Ung of Quintiles recent presentation, Outsourcing Oncology Molecular Biomarkers - Considerations for Emerging Countries from the Clinical Development of Cancer Drugs in China Download the PDF

New Global Trends in Novel Oncology Drug Development

Fri, 01 Oct 2010 10:37:43 -0400

Download Harish Dave, MD, MBA of Quintiles recent presentation New Global Trends in Novel Oncology Drug Development from the Clinical Development of Cancer Drugs

Personalized Anti-Cancer Therapy Development in China

Fri, 01 Oct 2010 10:17:16 -0400

Download the slides from Michael Shi, M.D. of Novartis recent presentation, Personalized Anti-Cancer Therapy Development in China from the Clinical Development of Cancer Drugs in China

Using Real-Time Data to Drive Better Decisions, Faster

Thu, 30 Sep 2010 12:57:35 -0400

This white paper examines the advantages afforded by access to real-time data during the course of a clinical trial. Download the PDF

QUINTILES, HKPI, RAMCO ANNOUNCE JOINT VENTURE IN EGYPT

Wed, 29 Sep 2010 08:58:07 -0400

September 29, 2010 - Quintiles, Health Kare Pharma International (HKPI), and Ramco Import and Export today announced the formation of a joint venture to provide commercialization services in Egypt.

HUYA, QUINTILES ANNOUNCE PARTNERSHIP TO CO-DEVELOP CANCER THERAPY

Tue, 28 Sep 2010 08:23:05 -0400

September 28, 2010 - HUYA Bioscience International (HUYA) and Quintiles announced an agreement to co-develop a new cancer drug, HBI-8000, sourced in China by HUYA.

Podcast: Cardiac Safety in Clinical Research

Fri, 24 Sep 2010 10:19:57 -0400

J.Rick Turner, Ph.D., Senior Scientific Director, Cardiac Safety Services at Quintiles, discusses the importance of cardiovascular assessments in clinical development.

Reinventing Safety

Wed, 22 Sep 2010 12:00:00 -0400

When you integrate all your safety information, you can make better decisions, navigate regulatory hurdles and get to market faster. Download the PDF

The Evolving Role of Neuroimaging in Future AD Clinical Trials

Tue, 21 Sep 2010 15:01:20 -0400

Download the slides from Philip Scheltens, MD VU Medical Center, Amsterdam recent presentation, The Evolving Role of Neuroimaging in Future AD Clinical Trials

The Evolving Role of Neuroimaging in Future AD Clinical Trials

Tue, 21 Sep 2010 14:48:33 -0400

Watch the video of Philip Scheltens's, MD of VU Medical Center recent presentation, The Evolving Role of Neuroimaging in Future AD Clinical Trials from the Quintiles Symposium at ICAD 2010.

Navigating Future Challenges in Alzheimer's Disease Trials

Tue, 21 Sep 2010 13:54:12 -0400

Quintiles’ own Alzheimer’s experts, Amir Kalali, Roza Hayduk and Lynne Hughes, sum up the insights and discoveries that could lead to the next breakthrough for Alzheimer’s disease.

Scaling Up for Safety: How to Gain Efficiencies without Sacrificing Quality

Thu, 16 Sep 2010 16:30:24 -0400

Read how Quintiles set-up a complete pharmacovigilance operation in a developing region in only six months for a leading pharma company. Download the PDF

Scanning for Promise

Wed, 15 Sep 2010 18:38:41 -0400

Learn how healthy volunteers and Alzheimer’s patients were successfully recruited within the required six-month time frame. Download the PDF

Electronic Submissions: Ensure Quality, Speed Timelines

Wed, 15 Sep 2010 17:27:28 -0400

We offer innovative thinking and proactive planning to start your submission on the right track. Download the PDF

Central and Eastern Europe and the Middle East Phase II/III Fact Sheet

Wed, 15 Sep 2010 15:58:07 -0400

Central and Eastern Europe and the Middle East fact sheet on Phase II/III trials. As the market leader with more than 10 years’ experience, Quintiles has established clinical trial standards in the region. Download the PDF

Southeast Asia Phase II/III Fact Sheet

Wed, 15 Sep 2010 15:51:26 -0400

This fact sheet on phase II/III clinical development in Southeast Asia demonstrates our unmatched experience and expertise ensure high-quality, on-time project delivery. Download the PDF

Data Standardization: Increase Efficiency, Save Time

Wed, 15 Sep 2010 15:48:27 -0400

Since 2003 Quintiles has delivered CDISC SDTM data in over 300 studies for more than 80 sponsors. Learn how we can help you meet your CDISC submission requirements. Download the PDF