Quintiles Information Library Custom Feed

Nordic Region Market Access

Tue, 22 May 2012 10:20:07 -0400

The countries of the Nordic region are, together, one of the most important pharmaceutical marketplaces in Europe. Their significance is due to their combined size, 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

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

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

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

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

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

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

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

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

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

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

Reinventing Biopharma

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

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

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

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.

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

ISPOR Europe 2012

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

Quintiles will have an exhibit

ISPOR US 2012

Thu, 12 Jan 2012 11:36:23 -0400

Quintiles will have an exhibit

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

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

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

Tomorrow's Vision. Today's Reality.

Wed, 23 Nov 2011 10:14:30 -0400

The growing impact of real-world and late phase (Phase IIIB/IV) research. Download the PDF

Market Intelligence - When There's No Room for Error Fact Sheet

Thu, 17 Nov 2011 12:37:51 -0400

In the world of biopharmaceutical development, market researchers are in the hot seat. Crucial decisions hinge on research results more than ever, and each decision must be made even faster to have real impact. Download the PDF

Leveraging Compliance for Sustainable Business Advantage

Wed, 16 Nov 2011 15:57:34 -0400

Article from Update Magazine, a publication of FDLI. “Leveraging Compliance for Sustainable Business Advantage” by Robert A. Rhoades, VP, Quality & Compliance Consulting Download the PDF

Quintiles Sells Minority Interest in Invida

Tue, 15 Nov 2011 16:31:22 -0400

November 15, 2011 – Quintiles has sold its minority interest in Invida, an Asia Pacific commercial solutions joint venture, to the Italy-based Menarini Group, which is acquiring Invida in its entirety.

Franchise Influence and Leverage Mapping

Thu, 10 Nov 2011 12:43:05 -0400

In this industry it’s not just whom you know, but who knows you and how far their sphere of influence reaches. Download the PDF

Multi-Channel Strategy

Wed, 09 Nov 2011 11:32:16 -0400

Rethinking the Real Points of Power Today, pharmaceutical and biotech companies relying on a conventional communication strategy aimed squarely and exclusively at physicians find themselves 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 Acquires VCG & Associates and VCG Bio

Wed, 19 Oct 2011 08:30:00 -0400

October 19, 2011 – The acquisition of VCG & Associates and VCG BIO strengthens Quintiles’ comprehensive commercial services in sales and brand solutions, product solutions, product distribution and market access.

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 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.

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

Improving Adherence

Wed, 21 Sep 2011 15:15:16 -0400

Newly diagnosed diabetics have a critical need for disease and drug education. But medical professionals lack the time. Clinical Educators can fill the gap. Download the PDF

The Value of Dual Perspectives

Wed, 21 Sep 2011 00:19:59 -0400

When one of the world’s largest pharmaceutical companies needed insight into how key components of their tactical sales approach were actually implemented in the field, they looked to Quintiles Market Intelligence. 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 Market Research Expert Honored by American Marketing Association Foundation

Thu, 15 Sep 2011 10:37:48 -0400

September 15, 2011 – Quintiles announced that The American Marketing Association (AMA) Foundation selected an article co-authored by Pieter Sheth-Voss, of Consulting at Quintiles, to receive the 2011 David K. Hardin Award.

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.

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, Kadrige Open E-Solutions Operation in the US

Tue, 02 Aug 2011 09:07:36 -0400

August 2, 2011 – Quintiles and Kadrige, the market leader in e-detailing and multichannel sales solutions for the pharmaceutical and healthcare industries, today announced the opening of the first Kadrige office in the U.S.

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 Helps Biopharma Companies Turn Compliance into a Business Advantage

Wed, 29 Jun 2011 09:30:00 -0400

June 29, 2011 – Elevating compliance to achieve a strategic advantage allows biopharmaceutical companies to respond more rapidly to ever-changing conditions in the New Health, according to a new report from Consulting at Quintiles.

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

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

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.

CDRH's Proposed Changes to the Premarket Notification [510k]

Fri, 27 May 2011 16:31:42 -0400

On January 19, 2011, the FDA unveiled a plan to improve the 510(k) program, involving 25 actions the agency intends to implement during 2011, including new guidance and enhanced staf training. 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.

Product Solutions

Mon, 16 May 2011 13:43:27 -0400

Product Solutions give pharma the insights needed to better gauge and drive the likelihood of a new product’s success from both clinical and commercial perspectives. Download the PDF

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.

The Art of Compliance

Thu, 21 Apr 2011 16:36:35 -0400

The Art of Compliance is more than just meeting regulatory requirements for a new drug, biologic or medical device. It is the ability to elevate compliance beyond execution to achieve strategic advantage. Its insight-based solutions facilitate quick and appropriate response to repidly changing conditions. Download the PDF

Vaccine Insights

Tue, 19 Apr 2011 16:22:11 -0400

Quintiles’ Jason Baumgartner, Life Sciences Consulting Director, presented on “Understanding Socio-Economic Drivers to Increase Vaccination Coverage” at the World Vaccine Congress 2011 Download the PDF

New Healthcare Architecture to Maximize Vaccine Coverage Rates

Tue, 19 Apr 2011 12:48:05 -0400

Jason Baumgartner discusses the steps required to create a complete healthcare architecture the shift among biopharma toward preventive medicine.

Commercial Solutions from Quintiles Canada

Mon, 18 Apr 2011 10:42:34 -0400

A conversation with Ian McBeath, General Manager, Commercial Solutions, Quintiles Canada, in Canadian Pharmaceutical Marketing magazine. 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.

Podcast: Process Driven Compliance

Thu, 31 Mar 2011 14:14:17 -0400

Bob Rhoades, Practice Leader for Quality Systems with Consulting at Quintiles, explains the need for a process-driven approach to regulatory compliance.

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.

Quintiles Named a Preferred Provider to Global Health Product Development Partnership Consortium

Fri, 25 Mar 2011 07:18:56 -0400

March 25, 2011 – Quintiles has been named a preferred provider to a consortium of 14 global health Product Development Partnerships (PDPs).

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

Late Phase Research

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

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

Asia is Key to Driving Innovation in Drug Development and Overcoming Industry Challenges

Sun, 13 Mar 2011 00:00:00 -0400

March 13, 2011 – Asia is rapidly becoming a new frontier for drug development as Western companies seek to develop and register their products, while emerging Asian companies seek new capabilities to globalize products.

Asia

Tue, 08 Mar 2011 19:00:00 -0400

This paper examines new development models as Western companies seek to develop and register their products in Asia, while emerging Asian companies seek new capabilities to globalize products.

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.

The Current Regulatory Landscape for Cardiac and Cardiovascular Safety Assessments - Part II

Thu, 24 Feb 2011 11:06:04 -0400

Last month, in Part I of this two-part series, we provided an overview of the history of formalized cardiac safety assessment, a brief discussion of Download the PDF

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

Wed, 23 Feb 2011 12:29:06 -0400

The F ood and Drug Administration Amendments Act of 2007 (FDAAA) authorized the US Food and Drug Administration (FDA) to require that a Risk Evaluation Download the PDF

The Current Regulatory Landscape for Cardiac & Cardiovascular Safety Assessments: Part I

Tue, 22 Feb 2011 14:01:16 -0400

The history of formalized cardiac safety assessment, and the dedicated study used to investigate a drug’s propensity to increase the length of the QT interval. Download the PDF

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

Demonstrating Bioequivalence for Locally Acting/Targeted Delivery Drugs

Tue, 22 Feb 2011 13:13:55 -0400

Bioequivalence studies play a crucial role in drug development as companies pursue line extensions, make manufacturing changes, develop generic drugs and seek US Food and Drug Administration (FDA) approval via the abbreviated drug approval pathway known as 505(b). 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.

Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part II

Sun, 20 Feb 2011 09:56:28 -0400

We provide overviews regarding the role of the regulatory professional, patent attorney (PA) and chemistry, manufacturing and controls (CMC) professional for the IP assessment. In addition, a case study is presented to tie together the concepts discussed in Parts I and II. Download the PDF

Key Aspects of Pharmaceutical Due Diligence Intellectual Property Assessment—Part I

Sun, 20 Feb 2011 09:46:46 -0400

This article reviews regulatory legislation enacted to provide additional marketing exclusivity in addition to patent protection. 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

Improved Commercialization Strategy through Stakeholder Network Mapping

Mon, 07 Feb 2011 10:22:44 -0400

Understanding the KOL and physicians influencer landscape is a mission critical component of a bio-pharma product’s market access strategy and commercialization plan. Influencer network mapping Download the PDF

Understanding Physician Preferences and Attitudes

Mon, 07 Feb 2011 10:15:00 -0400

This collection of case studies demonstrates how Market intelligence is used to gain a comprehensive understanding of physician preference and prescribing attitudes for RA drugs. Download the PDF

The Patient is Waiting - Quality's Quiet Impact on the Public Trust - Risky Business, Chapter 8

Wed, 02 Feb 2011 14:50:18 -0400

Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter eight carefully steps into the controversies surrounding the public’s expectations about the affordability, effectiveness and safety of prescription drugs. Download the PDF

Money and Morals - Management Responsibility in the Pharmaceutical Industry - Risky Business, Chapter 6

Wed, 02 Feb 2011 14:26:26 -0400

Chapter Six Excerpt from Risky Business: Managing the Quality of America’s Medicines by Robert A. Rhoades 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

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 Commercialization Strategies conferences - Nicole Connelly

Mon, 31 Jan 2011 16:33:02 -0400

Stakeholder Focus in Early Oncology Commercialization

HTA Watch - Integrated solutions to maximize product potential

Mon, 31 Jan 2011 10:26:08 -0400

Healthcare agencies worldwide routinely use centralized assessments to make informed decisions concerning reimbursement of medicines and other health technologies. These Health Technology Assessments (HTA) can impact Download the PDF

Podcast: Market Segmentation

Thu, 27 Jan 2011 09:04:49 -0400

Ismael Carreras, Ph.D., senior research director, market intelligence at Quintiles, details some new approaches to market segmentation for the biopharmaceutical industry.

Managed Entry Services

Mon, 20 Dec 2010 15:21:27 -0400

Managed Entry Services from Quintiles pairs an established national team with a powerful combination of unique competencies, rich NHS knowledge and extensive local relationships. Download the PDF

QUINTILES APPOINTS VINCENT AURENTZ TO LEAD CUSTOMER SOLUTIONS BUSINESS

Thu, 16 Dec 2010 09:00:00 -0400

December 16, 2010 - – Quintiles announced the appointment of Vincent Aurentz as Executive Vice President, Customer Solutions Business, to head a newly formed unit of dedicated customer teams that will deliver customized solutions across Quintiles’ global businesses.

Consulting – Breakthrough Thinking Built on Experience

Tue, 23 Nov 2010 13:36:29 -0400

Consulting at Quintiles brings a critical element to engagements: fresh thinking built on a full lifecycle understanding of biopharma realities today. 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

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.

QUINTILES AND KADRIGE PARTNER TO IMPROVE COMMERCIALIZATION OF PHARMACEUTICAL BRANDS

Tue, 16 Nov 2010 09:00:00 -0400

November 16, 2010 – Quintiles, and Kadrige, announce a global alliance that brings innovative models to physician detailing to help biotech and pharmaceutical companies increase productivity, overcome complexity and more efficiently demonstrate value for their therapies.

Post-Marketing: Thriving in the FDA’s New Reign of Enforcement

Fri, 12 Nov 2010 16:02:49 -0400

Part III in a three-part webinar series titled: Process Driven Compliance for a Competitive Advantage – the right approach to lifecycle quality in a new

QUINTILES WINS SCRIP AWARDS ‘BEST CLINICAL RESEARCH ORGANIZATION’ FOR SECOND CONSECUTIVE YEAR

Wed, 10 Nov 2010 14:25:12 -0400

November 9, 2010 - For the second consecutive year, Quintiles has received Scrip Awards Best Clinical Research Organization honors based upon judging by an independent panel of prestigious life sciences experts.

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.

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

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

Marketplace Success

Fri, 22 Oct 2010 16:11:38 -0400

The real value of working with the consulting group at Quintiles is that we help you chart the best path to marketplace success. Download the PDF

QUINTILES UNVEILS GLOBAL SERVICE OPERATIONS CENTER

Thu, 21 Oct 2010 17:27:25 -0400

October 22, 2010 - Quintiles announced the official opening of its new Global Information Technology (IT) Service Operations Center in Bangalore, India providing intelligent monitoring, control and triage of system events across Quintiles’ technology cloud.

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

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.

Patient-Centric Services

Mon, 11 Oct 2010 14:52:09 -0400

Just as payers are growing in influence, all roads are pointing back to the patient more directly and acutely. Quintiles Patient-Centric Services can maximize the value of your brands. Download the PDF

How informative is your segmentation?

Sun, 10 Oct 2010 17:17:40 -0400

Article published by Quintiles' Pieter Sheth-Voss in the Winter 2010 issue of Market Research provides a fresh perspective on the art of segmentation. Download the PDF

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?

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

Podcast: Biopharma Needs Value Focused Commercial Model

Thu, 30 Sep 2010 15:46:24 -0400

Jim Featherstone, Vice President within the Consulting group at Quintiles, talks to Outsourcing-Pharma about some of the challenges of commercializing a new drug product

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.

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

Advancing Oncology Care Through Innovative Treatment Approaches

Wed, 22 Sep 2010 08:19:57 -0400

In this new white paper, Quintiles’ oncology experts Harish Dave and Eric Groves summarize the new findings and promising results presented at the June ASCO 2010 meeting. Download the PDF

Closing Summary

Tue, 21 Sep 2010 16:41:42 -0400

Watch the video from Roza Hayduk, MD of Quintiles closing summary from the Quintiles Symposium, Navigating the Future Challenges in Alzheimer's Disease Trials at ICAD 2010.

Panel Discussion

Tue, 21 Sep 2010 16:35:20 -0400

Watch the video of the panel discussion from the Quintiles Symposium Navigating the Future Challenges in Alzheimer's Disease Trials at ICAD 2010.

Can Innovative Trial Designs Improve Success Rates of Future AD Clinical Trials

Tue, 21 Sep 2010 16:27:33 -0400

Download the slides from Paul Aisen, MD University of California, San Diego recent presentation, Can Innovative Trial Designs Improve Success Rates of Future AD Clinical Trials

Can Innovative Trial Designs Improve Success Rates of Future AD Clinical Trials

Tue, 21 Sep 2010 16:17:25 -0400

Watch the video of Paul Aisen, MD of University of California, San Diego recent presentation Can Innovative Trial Design Improve Success Rates of Future AD Clinical Trials from the Quintiles Symposium at ICAD 2010

Behavior as an Outcome in Disease Modifying AD Trials

Tue, 21 Sep 2010 16:07:30 -0400

Download the slides from Jeffrey Cummings, MD Cleveland Clinic recent presentation, Behavior as an Outcome in Disease Modifying AD Trials from the Quintiles Symposium at ICAD 2010

Jeffrey Cummings, M.D.

Tue, 21 Sep 2010 15:11:50 -0400

Jeffrey Cummings, MD Professor of Neurotherapeutics and Drug Development Cleveland Clinic Lerner College of Medicine Director, Cleveland Clinic Lou Ruvo Center for Brain Health Jeffrey

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.

Can Biomarkers Enhance Success Rates in Future AD Clinical Trials

Tue, 21 Sep 2010 14:37:47 -0400

Download the slides from Eric Siemers, MD of Eli Lilly and Company recent presentation, Can Biomarkers Enhance Success Rates in Future AD Clinical Trials from

Welcome and Introduction

Tue, 21 Sep 2010 14:17:17 -0400

Download the slides from Amir Kalali, MD Quintiles as he welcomes attendees to the Quintiles Symposium, Navigating the Future Challenges in Alzheimer's Disease Trials

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.

Navigating Future Challenges in Alzheimer's Disease Trials

Tue, 21 Sep 2010 13:42:03 -0400

Watch the Welcome and Introduction video by event Chairman, Amir Kalali, M.D., Vice President, Medical & Scientific Services at Quintiles

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

Safety Strategy & Optimization

Tue, 14 Sep 2010 12:06:24 -0400

Learn how to enable your safety group to become a value-added contributor throughout the product lifecycle. Download the PDF

Re-energizing a Brand

Wed, 01 Sep 2010 14:06:53 -0400

Learn how Quintiles revamped the consumer marketing plan for an oral health product, boosting brand awareness by 90% and expanding the overall market size. Download the PDF

PHARMAXIS SELECTS QUINTILES TO COMMERCIALIZE BRONCHITOL

Tue, 31 Aug 2010 09:00:00 -0400

August 31, 2010 – Quintiles announced a strategic agreement with Pharmaxis to provide a broad range of commercial solutions to support the European launch of Bronchitol®, an innovative treatment for cystic fibrosis.

Mapping the Future in Oncology Drug Development

Fri, 27 Aug 2010 10:32:39 -0400

Industry veterans Harish Dave and Eric Groves summarize key findings of Quintiles’ ASCO Ancillary Event, Mapping the Future in Oncology Drug Development

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

New Pilot Examples Exploring these Novel Approaches

Fri, 13 Aug 2010 15:10:14 -0400

Daniel Haller, MD of the University of Pennsylvania Presents on New Pilot Examples Exploring these Novel Approaches.

Welcome and Introductory Remarks

Fri, 13 Aug 2010 14:58:43 -0400

Welcome and Introductory Remarks at Quintiles Ancillary Event at ASCO 2010

Behavior as an Outcome in Disease Modifying AD Trials

Fri, 06 Aug 2010 16:03:23 -0400

Watch the video of Jeffrey Cummings, M.D. of Cleveland Clinic recent presentation, Behaviors as an Outcome in Disease Modifying AD Trials from the Quintiles Symposium at ICAD 2010

Can Biomarkers Enhance Success Rates in Future AD Clinical Trials

Fri, 06 Aug 2010 15:57:30 -0400

Watch the video of Eric Siemer's recent presentation Can Biomarkers Enhance Success Rates in Future AD Clinical Trials at the Quintiles Symposium, Navigating Future Challenges in Alzheimer's Disease Trials at ICAD 2010

New York State's New PACeR Clinical Data Network

Thu, 05 Aug 2010 16:44:28 -0400

This briefing describes how the PACeR initiative has connected hospitals, physicians, patients' homes and pharmaceutical scientists to provide valuable insights into current, real-world medical practices. Download the PDF

A Blueprint for Clinical / Commercial Convergence

Thu, 05 Aug 2010 10:34:12 -0400

The development model for bio pharmaceutical companies must shift from two divergent paths to one that combines these two resources with market access strategy, information and capabilities. Download the PDF

Implementing an Opioid Class: REMS A Process That Meets Pt Needs and Uses Pharmacy Workflow

Fri, 30 Jul 2010 13:39:44 -0400

Mary Mease's Poster from DIA US 2010 "Implementing an Opiod Class REMS: A Process that Meets Patient Needs and Uses Exisiting Pharmacy Workflow" Download the PDF

QUINTILES ANNOUNCES NEW EUROPEAN HEADQUARTERS

Thu, 29 Jul 2010 13:46:48 -0400

July 29, 2010 - Quintiles, announced that it is re-locating its European headquarters to within 30 minutes of Heathrow Airport at Green Park, Reading overlooking the M4 motorway.

Managing Pharmacovigilance as a Business

Wed, 28 Jul 2010 14:38:56 -0400

The three steps required to develop a strategic approach to global capacity management. Download the PDF

Communication Strategies for Risk Minimization

Mon, 12 Jul 2010 08:24:56 -0400

In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product Download the PDF

Generic Drug Approvals in the US Prior to the Hatch-Waxman Act

Mon, 12 Jul 2010 08:19:54 -0400

It is a common misconception that the Hatch-Waxman Act of 1984 created the generic drug approval process in the US. A recent article claimed there were Download the PDF

Drug Liability Rules in the EU

Mon, 12 Jul 2010 03:51:38 -0400

Klara Dalmay's presentation "Drug Liability Rules in the EU" at DIA US 2010 Download the PDF

Executive Vision Forum 2010: Convergence of Data

Fri, 09 Jul 2010 00:11:09 -0400

Paul Mattes, Managing Director, Microsoft. Presentation about the convergence of data and technology at Executive Vision Forum 2010. Download the PDF

Executive Vision Forum 2010: Convergence of Stakeholders

Fri, 09 Jul 2010 00:08:04 -0400

A Holistic Approach to Patient Outcomes - Brian Sweet, CPO, WellPoint. Presentation about the convergence of stakeholders. Download the PDF

Executive Vision Forum 2010: Clinical and Commercial Convergence

Thu, 08 Jul 2010 23:58:38 -0400

Pasquale Cetera, VP Portfolio Management, Merck, presentation about the convergence of Clinical and Commercial. Download the PDF

The Evolution of Oncologic Drug Development

Thu, 08 Jul 2010 08:33:55 -0400

Despite a doubling in the number of candidates in the cancer drug pipeline from 1990 through 2006, the overall US approval rate for cancer drugs Download the PDF

Building An Effective Compliance Program in Healthcare Products R&D

Wed, 07 Jul 2010 17:05:40 -0400

Michael Swiatocha's presentation at DIA US "Building An Effective Compliance Program in Healthcare Products R&D" Download the PDF

Quality CT

Wed, 07 Jul 2010 16:53:13 -0400

Jan Pierre's presentation at DIA US 2010 Quality CT Download the PDF

FDA Requirements for Clinical Studies in Pediatric Patients

Wed, 07 Jul 2010 14:22:47 -0400

Differences in the physiology of adults and children can produce significant differences in the way they respond to drugs and vaccines. Without adequate data on pediatric Download the PDF

On the Origin of the Animal Rule

Wed, 07 Jul 2010 14:16:02 -0400

New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible Download the PDF

Key Challenges to US Topical Ocular Drug Development

Wed, 07 Jul 2010 14:08:36 -0400

This article examines five key facets of the topical ocular drug industry to highlight key challenges associated with ocular drug development. An understanding of ophthalmology Download the PDF

Follow-on Biologics in the EU & US

Wed, 07 Jul 2010 14:03:04 -0400

Follow-on biologic (FOB) is the generally accepted terminology, although “biogeneric” is often favored by the generic drug industry. European and Canadian regulatory agencies refer to Download the PDF

CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics

Wed, 07 Jul 2010 13:54:28 -0400

This article summarizes some of the issues pertaining to biosimilars in Europe that are also likely to impact eventual FOB approval testing in the US. Download the PDF

Syndicated Solutions

Wed, 30 Jun 2010 12:03:23 -0400

Astellas needed to rapidly ramp up its sales force by 50% to take advantage of a projected $1 billion opportunity. Quintiles provided a new risk. Download the PDF

Challenging Traditional Outsourcing Models Using Core And Non-Core Assessment

Wed, 30 Jun 2010 12:00:00 -0400

New Frontiers

Tue, 08 Jun 2010 21:24:59 -0400

By utilizing a deliberately flexible monitoring schedule, Quintiles was able to accommodate fluxes in enrollment and substantial variations in enrollment from site to site. Download the PDF

Brand Solutions

Tue, 08 Jun 2010 15:57:00 -0400

There are five practical ways you can use our Brand Solutions expertise to increase the value of your brand. Download the PDF

Defining Value

Tue, 08 Jun 2010 15:39:10 -0400

Market Access, one of the many Consulting services available from Quintiles, stands ready to help you navigate the value substantiation process, from developing and demonstrating your product’s value platform to winning a preferred position on payer formularies and negotiating pricing and reimbursement contracts. Download the PDF

Vital Insights

Tue, 08 Jun 2010 15:27:25 -0400

Quintiles conducted an exhaustive analysis into global and U.S. responses to the use of comparative effectiveness research, identifying key signals to help the customer recognize risk scenarios. 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

Accelerated Access

Wed, 02 Jun 2010 15:27:11 -0400

Quintiles drew on extensive experience, a thorough understanding of the disease state and a myriad of tools in the Quintiles recruitment arsenal for a comprehensive solution to reach the right patients at the right time. Download the PDF

Outsourcing as strategic alternative to your own headcount

Tue, 25 May 2010 08:32:08 -0400

Approach of Roche Italy in outsourcing their primary care sales force to Quintiles Download the PDF

Challenges in Conducting Trials in Alzheimer's Disease

Fri, 21 May 2010 09:39:29 -0400

This paper examines the opportunities for conducting clinical trials in Alzheimer's disease in low and middle income countries.

Philip Scheltens, MD

Thu, 20 May 2010 10:00:24 -0400

Prof. Dr. Philip Scheltens, VU Medical Center, Amsterdam Dr Philip Scheltens studied at the VU University Amsterdam, Netherlands

Amir Kalali, MD

Thu, 20 May 2010 09:04:06 -0400

Amir Kalali, MD Vice President, Medical and Scientific Services CNS Global Therapeutic Team Leader, Quintiles Amir Kalali, MD, is Vice President, Medical and Scientific Services,

QUINTILES BOLSTERS MARKET ACCESS CAPABILITIES IN UK

Thu, 20 May 2010 07:43:12 -0400

May 20, 2010 – Quintiles today announced an agreement under which Nycomed has transferred a U.K.-based Healthcare Solutions Team to further strengthen Quintiles’ market access capabilities.

Transforming R&D

Tue, 18 May 2010 12:06:38 -0400

Faced with significant pipeline productivity challenges and an overly complex quality system, Quintiles paved the way for innovation. Download the PDF

QUINTILES AND KAISER PERMANENTE ANNOUNCE ALLIANCE TO ACCELERATE DRUG DEVELOPMENT

Tue, 18 May 2010 00:00:00 -0400

May 18, 2010 - Quintiles is accelerating drug development with the addition of Kaiser Permanente's Southern California Permanente Medical Group to its global site program

PharmaField awards 2010

Mon, 17 May 2010 10:52:27 -0400

Quintles employees take top honours at prestigious PharmaField Awards Download the PDF

Regulatory Landscapes for Future Antidiabetic Drug Development

Wed, 12 May 2010 15:36:59 -0400

In the March 2010 Journal for Clinical Studies, Dr. Erica Caveney and Dr. Rick Turner analyze the EMA Guidance on diabetes drugs and cardiovascular risk. Download the PDF

EMA’s Guidance on New Antidiabetic Drug Development

Wed, 12 May 2010 14:33:05 -0400

Assessing the EMA’s Guidance on New Antidiabetic Drug Development In January 2010, the European Medicines Agency (EMA) issued a draft guideline on antidiabetic drug development

Navigating Future Challenges in Alzheimer's Disease Trials

Mon, 10 May 2010 13:04:28 -0400

Learn more about this exciting program

Global Flexibility

Sun, 09 May 2010 22:27:31 -0400

PharmaMar needed to mobilize an effective sales force covering a market that spanned several countries and 20 official languages. With Quintiles, on-time recruitment against aggressive timelines made it possible to top sales goals in the first year. Download the PDF

Blockbuster Co-Promotion

Sun, 09 May 2010 22:20:30 -0400

A pharma company targeted seven countries for quickly promoting its new compound. In just four months, Quintiles recruited, trained and implemented highly effective field sales teams in all seven new countries. Download the PDF

Agile Outsourcing

Sun, 09 May 2010 22:10:54 -0400

Read how Quintiles established a pan-European infrastructure, recruited senior management and was achieving KPIs across 12 countries in just eight months. Download the PDF

Bridging Cultures

Sun, 09 May 2010 21:48:09 -0400

Takeda's growth strategy for Europe was to move into the Spanish market. Read how a Spanish team was assembled within a tight timeframe, with the help of Quintiles’ global and local reach, high profile in the marketplace, depth of experience and expertise. Download the PDF

Focused Co-Promotion

Sun, 09 May 2010 21:39:20 -0400

Roche Italy needed to find new, cost-effective ways to underpin sales of mature products. Uncover what happened when a unique partnership with Quintiles reinforced sales growth. Download the PDF

NHS Motivating Patients

Fri, 07 May 2010 13:43:34 -0400

In 2008, the NHS announced plans to offer free health checks for heart disease, stroke, diabetes and kidney disease. Learn why Quintiles was the right ally for the NHS to successfully launch this cardio risk assessment program. 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

Introduction to the Due Diligence Process

Tue, 27 Apr 2010 10:37:01 -0400

Introduction to the Due Diligence Process is the essential reference for regulatory professionals and pharmaceutical executives involved in the process of due diligence for product-based

New HIPAA Regulations and Their Impact on Clinical Research

Tue, 20 Apr 2010 13:27:14 -0400

In this article in Update magazine from FDLI, Quintiles' Judy Beach explains recent HIPAA changes and the potential impact on clinical research. Download the PDF

Podcast: Biopharma's Commercialization Challenges

Mon, 19 Apr 2010 09:29:41 -0400

Michael Ackermann, Ph.D., Vice President of Global Commercial Strategy and Alliance, Global Commercial Solutions at Quintiles, discusses the factors that are leading to a radical shift in how biopharmaceutical products are developed and commercialized.

FDA Requirements for Clinical Studies in Pediatric Patients

Thu, 01 Apr 2010 15:26:38 -0400

FDA Requirements for Clinical Studies in Pediatric Patients FDA rules around pediatric drug trials have been tightening, to ensure more targeted data on drug efficacy Download the PDF

Propelling Pediatric Research

Thu, 01 Apr 2010 15:05:24 -0400

Learn how Quintiles' global reach and rigorous research standards dramatically cut recruitment from 4 years to 1 in a childhood immunology study Download the PDF

Boosting Pediatric Enrollment

Thu, 01 Apr 2010 14:54:03 -0400

Read how Quintiles took a nasal influenza vaccine trial from the brink of delay to full recruitment in only two weeks. Download the PDF

Commercial – Identify, Promote and Prove Treatment Value

Thu, 01 Apr 2010 09:16:42 -0400

Quintiles has built an unmatched suite of commercial competencies that biopharma companies are leveraging for faster market access and sustained success. Download the PDF