Quintiles Case Studies Feed

Energizing Enrollment

Tue, 04 Oct 2011 14:22:38 -0500

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

Improving Adherence

Wed, 21 Sep 2011 15:15:16 -0500

Diabetes management education is especially critical to adherence and persistency among these newly diagnosed patients. But with health care professionals (HCPs) and long-term caregivers (LTCs) facing severely compressed schedules, there is limited time during appointments for these critical discussions. Download the PDF

The Value of Dual Perspectives

Wed, 21 Sep 2011 00:19:59 -0500

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

Improving Clinical Decision Making

Wed, 21 Sep 2011 00:18:33 -0500

With increased movement of pharmaceutical clinical studies to outsourced providers, a new paradigm of work was needed for clinical development between a Sponsor and a CRO. To meet this industry need, Quintiles partnered with a world class pharmaceutical company to build a new model for clinical trial planning and design. As part of this joint venture, Consulting at Quintiles is leveraging best practices previously implemented with other companies to highlight effective convergence of clinical and consulting expertise. Download the PDF

Easing Compliance Burden

Mon, 01 Aug 2011 16:50:33 -0500

In today’s pharmaceutical development environment, regulatory compliance is more important than ever due to increased regulatory oversight from health authorities coupled with growing penalties for Download the PDF

Off-Season Pediatric Enrollment

Fri, 24 Jun 2011 15:32:02 -0500

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 -0500

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

Strategies for Successful Patient Retention in Cardiovascular Outcomes Trials

Fri, 13 May 2011 18:03:29 -0500

In 2007, section 505(o) was signed into United States law as part of the Food and Drug Administration’s Amendments Act (FDAAA). This section authorizes FDA Download the PDF

Asia-Pacific Expertise

Wed, 11 May 2011 13:06:56 -0500

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

Advancing Vaccine Development in Australia and New Zealand

Mon, 11 Apr 2011 15:25:59 -0500

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.

Constant Vigilance

Wed, 16 Mar 2011 13:31:46 -0500

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 -0500

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

Scientific Bulletin Flow Cytometry

Wed, 09 Feb 2011 16:46:16 -0500

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

Improved Commercialization Strategy through Stakeholder Network Mapping

Mon, 07 Feb 2011 10:22:44 -0500

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 -0500

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

Competitive Edge - Ulcerative Colitis

Wed, 02 Feb 2011 15:47:02 -0500

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

Superior Teamwork - Renal Transplants

Wed, 02 Feb 2011 11:42:00 -0500

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 -0500

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 -0500

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

Diabetes - Therapeutic Focus

Tue, 01 Feb 2011 14:12:57 -0500

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 -0500

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 -0500

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 -0500

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 -0500

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 -0500

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 -0500

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 -0500

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

Securing Compliance

Thu, 27 Jan 2011 17:15:48 -0500

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

Exceptional Flexibility

Fri, 17 Dec 2010 13:45:54 -0500

Quintiles' best-in-class sales training capabilities, therapeutic expertise and established local relationships meant 3 key brands maintained share of voice in Spain. Download the PDF

Flexible Capacity

Wed, 24 Nov 2010 11:25:36 -0500

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

Scientific Bulletin PI3K Biomarker Assay

Fri, 15 Oct 2010 17:23:37 -0500

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 -0500

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

Employing Confidence

Mon, 11 Oct 2010 13:46:16 -0500

A top-10 pharmaceutical company turned to Quintiles to quickly integrate and deploy a large-scale sales force expansion in anticipation of multiple new product launches.

NHS Health Checks from Quintiles Fact sheet

Wed, 22 Sep 2010 13:50:33 -0500

Quintiles works with the NHS and biopharma to provide support for healthcare systems and introduce treatments which will deliver value to patients and the NHS Download the PDF

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

Thu, 16 Sep 2010 16:30:24 -0500

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 -0500

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

Global Data Solutions

Wed, 15 Sep 2010 11:18:01 -0500

Quintiles leveraged its unmatched experience and regional presence to open a free-standing, closed source data management center of excellence. Download the PDF

On-Time Results

Tue, 14 Sep 2010 17:35:12 -0500

The commitment of the Quintiles team to the delivery of the study on time despite significant problems outside our control proved decisive in this global trial. Download the PDF

Advancing Prevention in Korea

Tue, 14 Sep 2010 17:25:30 -0500

The original recruitment target and timeline were met with more than 1,100 patients screened to yield 420 randomized patients.

Managing Trauma

Tue, 14 Sep 2010 16:58:57 -0500

Quintiles overcame the unpredictability of patient recruitment due to the emergency setup and the client was able to file for approval based on phase II data only. Download the PDF

Re-energizing a Brand

Wed, 01 Sep 2010 14:06:53 -0500

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

Fact Sheet

Wed, 28 Jul 2010 09:16:40 -0500

Das CoPromotionTeam Magellan - Zahlen und Fakten - Download the PDF

Case Study

Tue, 27 Jul 2010 00:00:00 -0500

Das CoPromotionTeam Magellan – Eine Case Study Download the PDF

Promoting Adherence

Thu, 01 Jul 2010 14:42:48 -0500

In one of the longest running Quintiles HMS projects, nurse educators provide training on multiple sclerosis and therapy to new patients and their caregivers. Download the PDF

TQT for Modeling and Simulation: Deciding Factors

Wed, 30 Jun 2010 16:09:30 -0500

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

Outsourcing Exceeds Expectations

Wed, 30 Jun 2010 12:58:51 -0500

In Quintiles, Lilly found an ally with a kindred commitment to a best-in-class culture, plus a readiness to innovate in a challenging market. Download the PDF

Syndicated Solutions

Wed, 30 Jun 2010 12:03:23 -0500

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

Safeguarding Success

Thu, 24 Jun 2010 16:42:28 -0500

By providing a comprehensive safety program with an intergrated approach we were able to help the customer navigate complex safety requirements while improving efficiency, complience Download the PDF

Challenging Expectations

Thu, 24 Jun 2010 16:12:52 -0500

Quintiles' global coverage, experience and the systems to do the job were key to the success of this challenging trial. Download the PDF

Strategic Response

Thu, 24 Jun 2010 15:55:50 -0500

Quintiles was selected for geographical presence, previous experience in oncology, and a study team of professionals who had recently completed a trial on lung cancer. Download the PDF

Responsive Recruitment

Thu, 24 Jun 2010 15:49:35 -0500

Quintiles demonstrated the ability to quickly adapt to changing circumstances and to scale appropriate resources at short notice in order to meet shifting needs. Download the PDF

Precision Planning

Thu, 24 Jun 2010 15:37:44 -0500

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

Breakthrough Motivation

Thu, 24 Jun 2010 15:29:35 -0500

Quintiles' Expertise, Network Maximize Recruitment Download the PDF

Strategic Communication

Thu, 24 Jun 2010 15:16:27 -0500

Exceeding Global Recruitment Targets - 6 Months Early Download the PDF

Extraordinary Results

Thu, 24 Jun 2010 15:07:49 -0500

9-Month Savings Nets 50% More Patients Download the PDF

Total Commercial Solution

Wed, 23 Jun 2010 14:05:22 -0500

Tailored outsourcing Eases U.S. Launch for ProStrakan. Download the PDF

Groundbreaking Lessons

Wed, 23 Jun 2010 13:58:25 -0500

Oncology Nurse Educators surpass demanding goals. Download the PDF

Expediting Diagnosis

Wed, 23 Jun 2010 13:42:32 -0500

Nurse Educator Initiative boosts awareness and screenings. Download the PDF

Rapid Deployment

Wed, 23 Jun 2010 13:24:53 -0500

Quickly assembled Oncology MSL team exceeds expectations. Download the PDF

New Frontiers

Tue, 08 Jun 2010 21:24:59 -0500

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

Vital Insights

Tue, 08 Jun 2010 15:27:25 -0500

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

Accelerated Access

Wed, 02 Jun 2010 15:27:11 -0500

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

Case Study NIS

Mon, 24 May 2010 12:11:51 -0500

Non-Interventionelle Studien bieten die Datenbasis für den Nachweis der Effektivität einer Behandlung im Rahmen der praxisbezogenen Versorgungsforschung. Download the PDF

Case Study Patient Centric Service

Mon, 24 May 2010 11:44:58 -0500

Im Rahmen eines Patient Centric Programs wurden über 4.000 Rheumapatienten in der vorgegebenen Zeit in ein Betreuungsprogramm aufgenommen. Damit konnte die Behandlungsabbruchrate von 22% auf 9% Download the PDF

Transforming R&D

Tue, 18 May 2010 12:06:38 -0500

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

Data-Driven Market Success

Fri, 14 May 2010 10:47:45 -0500

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

Pioneering Strategy

Thu, 13 May 2010 17:20:26 -0500

Find out how a pharmaceutical company used the clinical trial educator strategy to accelerate enrollment in a multi-country cardiovascular clinical trial. Download the PDF

Rigorous Planning

Sun, 09 May 2010 22:35:13 -0500

A large pharma company needed to establish a pilot screening program with 50 participating practices, identify 4,500 people at risk and perform 2,500 bone densitometries in just nine months. Download the PDF

Global Flexibility

Sun, 09 May 2010 22:27:31 -0500

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 -0500

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 -0500

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 -0500

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 -0500

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

Collaborative Promotion

Sun, 09 May 2010 21:21:40 -0500

Learn what happened when Quintiles was chosen to fulfill and manage a syndicated project working closely with a woundcare company's sales team. Download the PDF

NHS Motivating Patients

Fri, 07 May 2010 13:43:34 -0500

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

Propelling Pediatric Research

Thu, 01 Apr 2010 15:05:24 -0500

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 -0500

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

The Right Balance

Wed, 31 Mar 2010 12:35:21 -0500

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

The Power of Consolidation: How to Gain Efficiencies without Sacrificing Quality

Wed, 31 Mar 2010 12:00:00 -0500

Biopharma companies are outsourcing more clinical trial services for greater cost efficiencies. Quintiles provides integrated services with one point of contact and streamlined management. Download the PDF

Patient Outreach

Tue, 23 Mar 2010 09:20:56 -0500

With no time for direct patient communications, a sponsor had to recruit patients from 32 countries. Recruiting through physicians delivered boosted international enrollment by 57%. Download the PDF

Anticipating the Challenge

Wed, 03 Mar 2010 21:47:14 -0500

Extensive experience and expertise in Alzheimer's Disease accelerated outcomes in multi-country Phase II study. Download the PDF

Advancing Innovation

Wed, 03 Mar 2010 21:47:14 -0500

Prescreening and safety measures simplified a Phase II study of a four-dose vaccine that required multiple rating scales. Download the PDF

Alzheimer's Inroads

Wed, 03 Mar 2010 21:34:48 -0500

A global, multi-site Phase III trial required a large number of patients with a specific number of sites and patients at each site. Download the PDF

Trumping Expectations

Mon, 01 Mar 2010 14:40:30 -0500

Quintiles sails past recruitment hurdles with tailored approaches that build momentum Download the PDF

Multinational Coordination

Fri, 26 Feb 2010 14:51:08 -0500

Coordinating a non-Hodgkin’s lymphoma study across six countries, our expert team exceeded expectations for efficiency and communication. Download the PDF

Unrivalled Global Reach

Mon, 22 Feb 2010 15:49:49 -0500

Failure was never an option with Quintiles’ guiding this complex global chronic heart failure study. Download the PDF

Global Efficiency

Wed, 10 Feb 2010 12:00:00 -0500

Read how Quintiles handled an eight-week hiatus due to a major protocol change and still trimmed two months off the enrollment period. Download the PDF

Swift Specialized Recruitment

Wed, 10 Feb 2010 12:00:00 -0500

Experience in the gastroenterology therapeutic area and the implementation of a multimedia recruitment campaign enabled Quintiles to complete enrollment five months ahead of schedule. Download the PDF

Managing Alliances with the Balanced Scorecard

Mon, 11 Jan 2010 06:00:00 -0500

“Managing Alliances with the Balanced Scorecard” details how Solvay Pharmaceuticals and Quintiles managed their innovative development alliance to deliver value for both companies. Download the PDF

Assessing the Business Impact of Comparative Effectiveness

Mon, 09 Nov 2009 17:11:07 -0500

The increasing use of Health Technology Assessments (HTA) is emerging as a policy issue that could have significant effects on every link in the product development chain. Download the PDF

Hepatitis B Vaccine-Successful Study Strategy in Asia

Mon, 09 Nov 2009 16:48:01 -0500

Quintiles helped a customer overcome recruitment and regulatory challenges for a Hepatitis B vaccine study in Asia. Download the PDF

Coordinating Safety Across Functions and Phases

Tue, 03 Nov 2009 17:43:07 -0500

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

Enabling Transformation

Wed, 30 Sep 2009 13:22:07 -0500

Biovitrum found an ideal opportunity to transform itself into a fully integrated specialty pharmaceutical company from a biotech discovery and early clinical development company. Download the PDF

Nasal Influenza Vaccine

Tue, 22 Sep 2009 09:39:24 -0500

Quintiles helped a customer overcome recruitment and regulatory challenges for a nasal influenza vaccine study in Argentina, Brazil and South Africa. Download the PDF

Precision Planning

Thu, 17 Sep 2009 15:49:34 -0500

Proactive planning yields high-quality data. Eight countries. More than 55,000 patients. Robust data management kept this post-marketing diabetes study on track and on time Download the PDF

Diagnosing an Underperforming Drug

Wed, 19 Aug 2009 13:25:12 -0500

Learn how Consulting at Quintiles leveraged Market Intelligence to uncover barriers to market success for a customer’s new product launch and delivered insights to optimize marketing and sales strategies. Download the PDF

Testing Disaster Readiness for Our Customer's Protection

Mon, 10 Aug 2009 12:57:42 -0500

Learn how Quintiles' planning protects trial data and provides seamless business continuity for clinical trials. Download the PDF

Metastatic Recurrent Head and Neck Cancer

Thu, 09 Jul 2009 11:29:51 -0500

Study drug plus platinum-based chemotherapy in treatment of squamous cell carcinoma of the head and neck (SCCHN) Download the PDF

eCTD Submissions

Sun, 21 Jun 2009 16:41:09 -0500

Read this case study which details information on eCTD submissions. Download the PDF

Advanced Gastric Cancer

Tue, 12 May 2009 14:27:45 -0500

To meet the challenges in patient recruitment, Quintiles relied on its therapeutic experience and extensive global site network to select the study sites most likely to treat patients meeting study entry criteria. In order to assist oncologists in working with the primary-tumor-related inclusion criteria, CRAs provided training to all sites based on a radiological briefing document. Download the PDF

Case Study - Kataryna Hoffler

Wed, 15 Apr 2009 14:50:25 -0500

Katarzyna Hoffler, która obecnie razem z rodziną mieszka w Singapurze, gdzie pracuje na stanowisku Start-up Managera, zaczynała pracę w firmie Quintiles w roku 2003 jako Monitor Badań Klinicznych. Wcześniej była lekarzem stażystą w Szpitalu Miejskim w dużym mieście, lekarzem Wojewódzkiego Pogotowia Ratunkowego oraz przedstawicielem medycznym firmy farmaceutycznej i Specjalistą Produktowym znanej firmy farmaceutycznej.

Case Study - Malgorzata Mirowska

Wed, 15 Apr 2009 14:46:22 -0500

Małgorzata Mirowska związana jest z firmą Quintiles od 2006 roku. Po ukończeniu studiów na wydziale rehabilitacji Katowickiej Akademii Wychowania Fizycznego rozpoczęła pracę w Katedrze Rehabilitacji AWF w Warszawie jako asystent. Chociaż praca ze studentami przynosiła Pani Małgorzacie satysfakcję, po dwóch latach zdecydowała się na zmiany. Postanowiła związać swoją zawodową karierę z branżą farmaceutyczną. Pracowała m.in. jako przedstawiciel medyczny oraz starszy specjalista ds. pulmonologii.

Case Study - Jacek Wolinski

Wed, 15 Apr 2009 14:41:43 -0500

Jacek Woliński związany jest z firmą Quintiles od dwóch lat. Początkowo pracował jako Dyrektor Operacji Klinicznych odpowiedzialny za dział badań klinicznych w Polsce. Od listopada zajmuje stanowisko Dyrektora Globalnych Operacji Klinicznych ds. jednego z Kluczowych Klientów.

Strong Site Relationships Support Rapid Recruitment

Fri, 27 Mar 2009 16:59:13 -0500

To conduct a worldwide oncology registration study, a top 10 pharmaceutical company came to a unit of Quintiles in Europe that focuses exclusively on oncology studies. Not only does the department head have 14 years of experience in cancer clinical research, but her 13 project managers were chosen specifically because of their extensive knowledge of how to run global cancer studies. Download the PDF

Prostate Cancer Case Study

Fri, 27 Mar 2009 16:52:02 -0500

A multi-center phase III randomized trial comparing Drug X in combination with prednisone to mitoxantrone and prednisone for advanced hormone refractory prostate cancer Download the PDF

Small Cell Lung Cancer

Fri, 27 Mar 2009 16:50:05 -0500

A randomized, double-blind, placebo controlled, multi-center, phase III study of Drug X plus chemotherapy (cisplatin and gemcitabine) versus chemotherapy alone in patients with advanced (stage IIIB or IV)non-small cell lung cancer (NSCLC) that have not received prior chemotherapy Download the PDF

Contracting Timeline

Fri, 27 Mar 2009 16:44:36 -0500

Aggressive Recruitment Speeds Time to Market. The goal: to accelerate a study of a top-priority drug for non-myeloid malignancy. Quintiles ramped up 36 sites in just two months. Download the PDF

Supercharging Possibilities

Fri, 27 Mar 2009 16:42:45 -0500

Recruiting the Right Breast Cancer Patients. Finding HER2 positive metastatic breast cancer patients, Quintiles doubled the sponsor’s enrollment rate in less than a year. Download the PDF

Colon Cancer

Fri, 27 Mar 2009 16:40:57 -0500

A randomized, open-label phase III study comparing Drug X with i.v. bolus 5- fluorouracil in combination with low-dose leucovorin as adjuvant chemotherapy in colon cancer patients with Dukes C tumors Download the PDF

Pediatric Expertise Conquers Enrollment Challenges

Fri, 27 Mar 2009 16:38:45 -0500

Quintiles’ pediatric specialists are thoroughly familiar with the current regulatory climate and pathways to pursue Pediatric Exclusivity. So when a major pharmaceutical company came to us for help gaining an exclusivity ruling, we understood immediately that the deadlines we were facing were unchangeable. Download the PDF

Irritable Bowel Syndrome

Fri, 27 Mar 2009 16:35:36 -0500

A double-blind, placebo-controlled, randomized, multinational study to investigate the safety and efficacy of two doses of Drug X against a comparator compound over 26 weeks in patients with diarrhea-predominant irritable bowel syndrome Download the PDF

Global Reach Leads to CNS Recruitment Speed

Fri, 27 Mar 2009 16:25:18 -0500

Quintiles CRO truly has global reach; A customer wanted to recruit 220 patients within 14 months at 25 US sites. Quintiles decreased enrollment time to just 8 months Download the PDF

Alzheimer's Disease

Fri, 27 Mar 2009 16:15:35 -0500

Quintiles worked with a client to help determine the safety and tolerability of drug x for Alzheimer's patients Download the PDF

Cardiovascular Expertise Results in Faster Enrollment Speed

Fri, 27 Mar 2009 13:24:13 -0500

Mega-trials require mega-expertise, especially when the global study is for an innovative cardiovascular drug to treat patients with acute coronary syndrome who have also undergone coronary artery bypass surgery. Download the PDF

Chronic Heart Failure

Fri, 27 Mar 2009 13:20:57 -0500

A phase II, double-blind, randomized, placebocontrolled, dose-comparative study of the efficacy, tolerability and safety of Drug X in subjects with chronic heart failure NYHA Class II/III Download the PDF

Faster than Expected

Fri, 27 Mar 2009 13:14:37 -0500

How Quintiles created an entire data management center from scratch. And developed a unique “collaborship” in the process. Download the PDF

Blended Site Monitoring

Fri, 27 Mar 2009 13:11:38 -0500

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

Accelerating a Trial Delayed by Slow Approvals

Fri, 27 Mar 2009 13:08:36 -0500

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

Launching a Successful Brand in a Genericized Market

Fri, 27 Mar 2009 11:30:44 -0500

The market for this particular category of muscle relaxants was owned by 10 mg tablets, both branded and generic. Our customer wanted to launch a 5 mg tablet that – contrary to physician and pharmacist preconceptions – was fully as effective as the 10 mg version.

Helping First Time Investigators Perform Like Pros

Thu, 26 Mar 2009 15:07:51 -0500

Helping first-time investigators perform like pros: early, intense attention ensures correct procedures and clean data Download the PDF

Making the Most of a Smart Move

Thu, 26 Mar 2009 15:04:23 -0500

In late 2007, Scotland-based ProStrakan Group plc seemed to have everything going for it: four new European product introductions planned for an 18-month period and near-term product launches with an aggregate peak sales potential of $400 to $500 million, both backed by a 340-person pan-European salesforce. Download the PDF

Grabbing a Leadership Position

Thu, 26 Mar 2009 14:59:19 -0500

Astellas-Quintiles Alliance Establishes Market Leadership Platform for Vesicare Download the PDF

Maneuvering a Drifting Project Back on Course

Wed, 25 Mar 2009 15:48:23 -0500

The NDA had been drifting within the FDA for years, and now it was subject to intense scrutiny by two agency reviewers.

Antibiotic Safety Assessment

Wed, 25 Mar 2009 10:53:22 -0500

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

Training Multiple Levels of Field Staff

Tue, 24 Mar 2009 20:09:29 -0500

Learn about the customer situation, critical issues, the commercial solution and results.

Sales Force Build

Tue, 24 Mar 2009 20:08:23 -0500

Learn about the customer situation, critical issues, the commercial solution and results.

Boosting Market Share

Tue, 24 Mar 2009 20:01:46 -0500

Learn about the customer situation, critical issues, the commercial solution and results.

Gain Capital & Retain Value

Tue, 24 Mar 2009 13:30:18 -0500

Cell Therapeutics was in need of capital to fund ongoing development expenses, but was not interested in further equity dilution. As an alternative, they considered monetizing a royalty interest in Trisenox®, their only marketed oncology product. Download the PDF

Core or Non-Core, CRO’s Evolving Role

Tue, 24 Mar 2009 13:27:08 -0500

The pressing need to control costs and reduce development timelines has led many biopharmaceutical manufacturers to increasingly outsource components of their clinical research programs. Download the PDF

Matching Risks with Rewards

Tue, 24 Mar 2009 13:08:43 -0500

A global pharmaceutical company had a new formulation of a core strategic asset half way through its pivotal Phase III studies, but another major product launch at the company was generating such significant expenses that it was squeezing the budget for this and other development programs. Download the PDF

Jumpstarting a Phase III Candidate

Tue, 24 Mar 2009 12:54:16 -0500

A global pharmaceutical company had a promising new formulation of a marketed product in early Phase III trials, but R&D budget pressures were likely to result in delays getting the product to market. Download the PDF

Project Coordination Centers

Fri, 20 Mar 2009 16:55:45 -0500

One day, a few years back, Quintiles dared to ask, “Why not?” Why not make investigators’ lives easier – and CRAs’ performance more efficient – by supplementing regular on-site visits with remote monitoring and investigator support? Download the PDF

All Change for Pharma Reps

Fri, 20 Mar 2009 13:49:21 -0500

How will the evolving world of healthcare delivery and decision-making affect the size and structure of salesforces? Download the PDF

Surmounting the Small Patient Population Challenge

Fri, 20 Mar 2009 10:58:20 -0500

At Quintiles,oncology expertise runs deep,from renowned cancer specialists to thoroughly trained project managers and CRAs. Download the PDF

Pancreatic Cancer Expertise

Fri, 20 Mar 2009 10:49:16 -0500

Quintiles’ experience with all types of oncology trials is extensive – but it was their specific experience with pancreatic cancer that helped a major pharmaceutical company out of a very difficult situation. Download the PDF