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International Clinical Trials

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Winter 2012

   
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Regulatory & Business Practice
Companion Diagnostics

Biomarker Momentum

Berwyn Clarke of Lab21 Limited highlights the resurgence in the use of biomarkers in the clinical development process, and considers the implications of new technology and recent EU and US development guidelines.
 
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Clinical Trial Outsourcing
Pharma-CRO Partnerships

Relationship Advice

Consultant John Faulkes considers the best course of action to ensure the sponsor-CRO relationship is successful, and suggests that  building trust and regular communication when partnership-building is essential.
 
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eCLINICAL
Drug Identication Links

Connecting Up

The ClinicalTrials.gov database has sought to increase the transparency of trial and drug data. Christopher Southan of ChrisDS Consulting and Hilary Stephenson of Sigma Consulting Solutions Limited suggest ways in which the resource can be improved.
 
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Software-as-a-Service

Trial Management from the Cloud

Jan Nielsen at BSI Business Systems Integration AG surveys opinion on cloud-based CTMS systems, and highlights the factors pharma companies must take into account when adopting this software.
 
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Developing Countries: Translation and EDC

Communication Crossroads

A number of challenges have prevented adoption of EDC in emerging countries but, as Karen I Politis Virk at Language Connections explains, progress is being made as a result of technological advances and translation guidelines.
 
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MEDICAL IMAGING AND QT STUDIES
Cancer Drug Trials

Preclinical Targets

Bioluminescent imaging can aid preclinical efficacy assessments by providing patient relevant models. Rajendra Kumari at PRECOS discusses the role this imaging platform will play in cancer drug development.
 
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Trial Management & Outsourcing
Budget Setting

Mature Approach

As the bid process for CROs becomes more competitive, John Bennett at JABPharma Ltd and Fiona Racher of Risk Decisions Limited recommend the adoption of a risk management strategy that allows sponsors to provide an accurate and reliable proposal.
 
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Regional trials
Regulatory Compliance: Developing Countries

Principled Progress

Conducting clinical trials in developing countries offers a number of practical and economic advantages. However, as Aarti Pandey and Swaminath Ganesh at Wipro Technologies discuss, ethical considerations must not be forgotten.
 
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Supply Chain & Manufacturing
R&D Outlook

Pressure on the Pipeline

Mark Egerton of Quotient Clinical suggests an innovative change to the supply chain process that will help the industry overcome the economic pressures that R&D is currently facing.
 
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Recessionary Environment
Site Management

Survival of the Brightest

The effects of the economic recession are being felt in both Big Pharma and small biotech companies. Alan Wade at CPS Research highlights the benefits of increased efficiency and diversification.
 
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Risk-Based Monitoring

Time for Change

Jules T Mitchel and Judith M Schloss Markowitz at Target Health Inc. consider the advantages of risk-based monitoring and direct data entry.



 
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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

Turkish Cargo starts to operate at Istanbul Airport its new hub

Turkish Cargo, the global air cargo brand, will perform its cargo transportation operations via passenger flights at the temporary satellite facility, which is completely satisfactory in terms of infrastructure at Istanbul Airport, as of April 6, 2019 at the same level of quality and care as previously.
More info >>

White Papers

Maximize the ROI of Your Post-Approval Research

Bioclinica

Expenditures in post-approval (Phase IV) research are going up across the pharmaceutical, biotech and medical device industries. Given the resources you’ve committed to post-approval research, you may be wondering if you’re getting the greatest possible return on your investment. Discover how to harness the power of post-approval research to increase data collection, reduce resource burn, save money, and maximize your ROI!
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Industry Events

World Pharma Week 2019

17-20 June 2019, Seaport World Trade Center, Boston

World Pharma Week will bring together a unique and international mix of large and medium pharmaceutical and biotech companies, CROs, leading universities and clinical research institutions, emerging companies and tool providers—making it a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies.
More info >>

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