Quintiles Information Library Custom Feed

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.

SCDM 2012

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

Quintiles will have an exhibit

DIA US 2012

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

Quintiles will have an exhibit

Quintiles Completes Acquisition of Advion BioServices

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

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

Quintiles Agrees to Acquire Premier GLP Bioanalytics Laboratory

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

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

Creating Metadata-Driven Program Logic

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

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

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

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

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

Podcast: Real-time Data and Patient Safety

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

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

Web-based ePRO Tools and Post-Marketing Studies

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

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

Off-Shoring - From Tactical to Strategic

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

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

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

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

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

Development of CDISC Tuberculosis Data Standards

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

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

Blind Review of Planned Analyses for Clinical Trials

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

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

Sample Size Estimation For Drug Combination In Fixed Dose Trials

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

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

Optimizing Type II Diabetes Drug Development

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

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

Using Regulatory Guidance to Get Credible Results with Missing Data

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Quintiles 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.

Creating Customized Patient Profiles using SAS ODS RTF and PROC TEMPLATE

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

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

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

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

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

The Impact of Globalization on the Statistical Services

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

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

Mixed models and Missing Data in Practice

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

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

Examples of Using Modelling and Simulation in Getting Treatments to Market

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

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

Mixed Models for Data from Thorough QT Studies

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

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

Regional Regulatory Non-inferiority Guidances and Beyond

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

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

Whatever Happened to Harmonisation?

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

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

Value Based Drug Development

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

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

Clinical – Smarter Trials, Accelerated Outcomes

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

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

The Changing Landscape of Pharma - Tilt to Asia

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

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

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.

Using Real-Time Data to Drive Better Decisions, Faster

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

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

Electronic Submissions: Ensure Quality, Speed Timelines

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

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

Data Standardization: Increase Efficiency, Save Time

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

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

CDISC Conversion: A Solution for Converting Legacy Databases

Wed, 15 Sep 2010 15:42:02 -0400

Quintiles helps you preserve the value of yesterday’s study data in today’s world of e-submissions. Download the PDF

The New Health Clinical Brochure

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

Japanese version available for download. Download the PDF

Challenging Expectations

Thu, 24 Jun 2010 16:12:52 -0400

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

Data-Driven Market Success

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

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

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

Wed, 31 Mar 2010 12:00:00 -0400

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

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

CVCT Forum: Preparing Data for the DSMB

Tue, 23 Feb 2010 14:41:48 -0400

Data Cleaning Issues — Preparing the Data for the DSMB How you prepare data for monitoring boards can help streamline your cardiovascular approval or delay 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

CDSIC – Electronic data submission

Thu, 13 Aug 2009 11:25:30 -0400

There is an increasing global requirement for Clinical Data Interchange Standards Consortium (CDISC) -based standardized data for regulatory submissions. Download the PDF

Services for Biotechnology

Mon, 20 Jul 2009 13:37:01 -0400

We Understand the Dynamic Needs of Biotech Download the PDF

CDISC Conversion of Legacy Databases

Mon, 20 Jul 2009 13:21:17 -0400

Preserve the Value of Yesterday's Study Date in Today's World of eSubmissions Download the PDF

QUINTILES, SAS ANNOUNCE DEVELOPMENT OF FIRST-EVER CLINICAL TRIALS STATISTICAL PROGRAMMING CERTIFICATION

Wed, 19 Nov 2008 14:36:21 -0400

November 19, 2008 - Quintiles, the world’s No. 1 pharmaceutical services company, and SAS are developing a unique program to produce certified specialists in the use of SAS programming to evaluate clinical trials results, the companies announced today.