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International Clinical Trials

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Summer 2013
   
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TRIAL MANAGEMENT

Study Management

Role Model

As the role of clinical research associates becomes more specialised, their skillset and knowledge must be expanded to take account of new technology tools and closer working with site teams, argue Marcin and Martyna Stefanowicz at Trial-Med.

 
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Bioinformatics

Living the Sample Life

The accelerated use of biomarker-based studies across R&D necessitates a new rigour and sophistication in sample and data management. Mark Collins at BioFortis makes the case for a more holistic approach to information and processes.
 
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GCP Audits

Self Improvement

Self-auditing of good clinical practice presents a conflict of interest and rarely helps improve trial delivery. Smaller, more proactive audits, on the other hand, can offer a more intelligent analysis, argues Matthew Weinberg at The Weinberg Group.
 
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Risk-Based Monitoring

Check Points

The pharma industry is keeping a close eye on the early adopters of risk-based monitoring approaches, prompting Becky Carpenter at ResearchPoint Global to consider the pros and cons, and offer some case studies to show the effi ciencies and savings that can be made.
 
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eCLINICAL

EDC Studies

Electro Motion

Evaluating the current state of electronic data capture, Stuart Cook at Quanticate asks how far off we are from a utopian e-clinical future, where data is recorded once and is available directly in the database.

 
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CLINICAL THERAPEUTICS
HIV Therapeutics

Combined Forces

Assessing the European HIV drug market, Deepika Pramod Chopda at Frost & Sullivan says that combination therapies are likely to rise due to higher success in treatment rates and stronger adherence by patients.
 
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PREVIEW
ICSE Preview

Show Time

With outsourcing now dominating the clinical research landscape, the upcoming ICSE event in Frankfurt is a must-attend.
 
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Regional trials
Global Operations

Beyond the Borders

With trials now being carried out worldwide – and often in nontraditional markets – study planners must consider country-specific differences in trial cost and quality of data. Jeffrey Handen and Irina Rafalovitch at Medidata Solutions report.
 
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South American Market

Latin Leads

Argentina is leading the way in Latin America, with a large number of Phase 3 trials across critical disease areas and a favourable set-up that is attracting pharma multinationals. Ashish Mehta at GlobalData offers a statistical picture.
 
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data management & statistical analysis
Data Analysis

No Limits

Life sciences companies are sitting on mountains of data, yet only extract a fraction of its value. Why be held back, says Rick Morrison at Comprehend Systems, given the advantages of the next generation of software tools?
 
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Drug delivery & Therapeutics

Antibiotic Development

Fighting Resistance

As Big Pharma backs away from antibiotic development, the field has opened up to smaller, innovative companies that work closely with universities. Michael McArthur at Procarta Biosystems illustrates some of the early-stage research being done.

 
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Central Labs
Biomarker Validation

Question Mark

A detailed understanding of how biomarkers can be assayed in drug development is pivotal for allowing critical decision-making. Edwin Janssen at Eurofins Global Central Laboratory outlines how rigorous validation is key to success.
 
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Clinical Laboratories

Direct Action

The growing use of biomarkers in Phase 1 trials raises the need for a flexible quality framework to help ensure data integrity, reconstructability and reliable results. Barbara Baert and Ellen Berteloot at Janssen explain.

 
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Training & Development
Business Planning

Train to Gain

Appropriate, well-delivered clinical research training is particularly important during hard economic times, helping to drive staff development and business performance, says Gerald Van Roey at the European Centre for Clinical Research Training.
 
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Trial Design
Adaptive Design

Rapid Response

They have the potential to transform clinical research, but adaptive designs also pose various operational and logictical demands. Fast response services to support mid-trial modifications may hold the answer, says Sue Miles at Packaging Coordinators, Inc.
 
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Intelligent Trials

Flexible Working

Adaptive designs can help pull off the balancing act of streamlining trials without risking poor design or delays. And the ethics and science can be improved too, as Ghanashyam Rao and Indu Singh at ELC Group explain.
 
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Protocol Writing

Words of Wisdom

With more complex trial protocols likely to be less successful, Julia Forjanic Klapproth at Trilogy Writing & Consulting emphasises the need for well-designed and communicated protocol documents.

 
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Interview

Business Insight

Good Advice

ClinTec’s Rabinder Buttar reveals some business tips and her thoughts on how companies can thrive in the decade ahead.

 
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Industry Interview

Thinking Allowed

Neta Kela-Madar of Biotec Services talks about supply strategies and working with regulation amid the globalisation of clinical trials.

 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

BioIVT Webinar Will Discuss How to Optimize Microbiome Research

BioIVT, a leading provider of research models and services for drug development, today announced that it is hosting a webinar entitled “The Microbiome: Understanding Why Collection and Processing Matters” at 11 a.m. ET on July 25.
More info >>

White Papers

Case Study: Amber™, featuring Pushclick Technology

SHL Group

The Amber™ Auto Injector is a single-dose, disposable auto injector with a unique patient-centric industrial design. This device features Pushclick™ technology, which enables it to be activated by simply pushing against the injection site, a total of only 2 simple steps. The unique ergonomic industrial design of the device provides various grip options when removing the cap and when performing the injection. Safety features and essential audible, visual and tactile feedback mechanisms are also integrated into the device.
More info >>

Industry Events

Drug Discovery 2018

9-10 October 2018, ExCeL Arena, London, UK

ELRIG’s flagship conference, Drug Discovery, has become the largest meeting of life sciences industry professionals in the UK. Now in its 12th year, Drug Discovery 2018 will take place in London’s Excel Arena. This 2-day event will bring together more than 1200 delegates and over 100 exhibiting companies from around the world who will highlight the latest ground-breaking research, discuss cutting-edge advances in the application of laboratory technology to understand disease biology and to identify novel chemical and biological candidate drugs.
More info >>

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