Quintiles Information Library Custom Feed

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

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

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

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.

DIA US 2012

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

Quintiles will have an exhibit

ASCO 2012 – Accelerating Investigator Success in Oncology Trials

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

Quintiles will have an exhibit

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.

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 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 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.

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.

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).

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

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

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

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

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

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

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.

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.

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.

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

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?

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

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.

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

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

The New Health Clinical Brochure

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

Japanese version available for download. Download the PDF

Biomarkers as an Approach to Improving Productivity in Oncology Drug Development

Thu, 19 Aug 2010 10:13:23 -0400

Richard Gaynor, MD of Eli Lilly presents Biomarkers as an Approach to Improving Productivity in Oncology Drug Development

Malaysia Prime Site

Fri, 02 Jul 2010 14:32:25 -0400

Adam Chasse, Sr. Director, Access to Patients explains the importance of Prime Sites and the impact of our clinical research partnership with the University of Malaya Medical Centre in Malaysia.

TQT for Modeling and Simulation: Deciding Factors

Wed, 30 Jun 2010 16:09:30 -0400

PK-PD modeling and simulation scientists from Quintiles rescued the sponsor's TQT protocol by determining key inputs needed to satisfy FDA guidelines. 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

Applications of Modeling and Simulation in Cardiac Safety Studies

Thu, 27 May 2010 15:35:28 -0400

Applications of Modeling and Simulation is discussed by Giridhar S. Tirucherai PhD, Director, Clinical PK-PD at Quintiles in the April issue of DIA Global Forum.

Assessing Cardiac Safety Throughout Clinical Development

Thu, 27 May 2010 15:32:09 -0400

Assessing Cardiac Safety Throughout Clinical Development and the ramifications for an integrated cardiac safety program is discussed by Rick Turner, Senior Scientific Director at Quintiles in the April issue of DIA Global Forum. Download the PDF

Emerging Biopharma Service Fact Sheet

Tue, 04 May 2010 00:25:54 -0400

Recognizing that the needs of emerging companies are unique, Quintiles has created a specialized team dedicated exclusively to small and mid-sized biopharma companies. Download the PDF

TQT Studies: Integrated Cardiac Expertise for Smarter Decisions, Sooner

Tue, 13 Apr 2010 09:41:55 -0400

At Quintiles, we offer you a complete solution for your TQT needs including our Phase I, Clinical Pharmacology and ECG Core Labs. Download the PDF

QUINTILES EXTENDS PHASE I CAPACITY AND CAPABILITIES

Mon, 08 Mar 2010 18:24:54 -0400

March 8, 2010 – Quintiles announced the opening of its expanded research facility in London, UK, increasing its Phase I capacity and extending its ability to drive progress in translational medicine.

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

BIOS Standardize Data with SPARC

Tue, 02 Feb 2010 00:00:00 -0400

There is an increasing global requirement for Clinical Data Interchange Standards Consortium (CDISC) -based standardized data for regulatory submissions. At Quintiles, we have proactively addressed this need by training our staff, gaining experience, and developing and implementing innovative solutions for creating data that adhere to current CDISC Study Data Tabulation Model (SDTM) specifications. 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

QUINTILES PARTNERS WITH FOUNDATION TRUST & UNIVERSITY TO IMPROVE PATIENT CARE AND DRIVE EFFICIENCY IN CLINICAL RESEARCH

Mon, 26 Oct 2009 11:53:57 -0400

October 26, 2009 - Guy’s and St Thomas’ NHS Foundation Trust and King’s College London sign collaborative agreement with Quintiles.

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

Phase One Services: Dr. Elizabeth Allen

Fri, 24 Jul 2009 15:58:40 -0400

We provide accurate and correct Phase I and IIa data quickly. We can help you make smart, safe decisions earlier to avoid repeating costly studies later.

Phase One Services: Dr. Philip T. Leese

Fri, 24 Jul 2009 15:53:13 -0400

To deliver quality data on time, we ensure that all clinical conduct is consistent, efficient and accurate to your protocol. But to do this we also need to recruit the right volunteers.

Phase One Services: Professor Timothy G.K. Mant

Fri, 24 Jul 2009 15:47:06 -0400

It's absolutely crucial that your Phase I/IIa partner places ethics, safety and expert clinical conduct at the heart of all their activities.

Validated Biomarker Menu

Tue, 14 Jul 2009 11:00:55 -0400

A comprehensive menu of validated cell, fluid and tissue based biomarker assays. Download the PDF

Phase I System Video

Wed, 01 Jul 2009 10:02:17 -0400

Phase I system enables you to make critical decisions earlier.

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.

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

QUINTILES TO OPEN PHASE I UNIT IN INDIA

Tue, 27 Jan 2009 11:14:10 -0400

January 27, 2009 – Quintiles Transnational Corp. announced a partnership with Apollo Hospitals Group to open a Phase I clinical trial unit in Hyderabad, India.

Monitoring for Quality

Thu, 22 May 2008 11:14:34 -0400

Scott Cooley, Executive Director, Phase IIIb/IV Product Management, Quintiles, discusses innovative and traditional resources in a risk-based monitoring program. Download the PDF