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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

Domestic companies predict a 16% growth in the South Korean pharma market during CPhI Korea

CPhI Korea, organized by UBM, closed its doors in Seoul after another record-breaking event that attracted 4,300 attendees and 147 exhibitors. During the event, UBM undertook an in-depth onsite survey of both international and domestic attendees, with domestic companies reporting a headline growth in the order of 16% across the South Korean pharma economy.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: Summary of Year 2013

Synergy Research Group

Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
More info >>

Industry Events

Partnerships in Clinical Trials Europe 2017

28-29 November 2017, RAI, Amsterdam

PCT Europe is back, bringing you the latest information from across the clinical trials spectrum and providing you with direct access to the industry's leading innovators. And this year, we're in Amsterdam!
More info >>

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