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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

Nanobiotix presents NBTXR3 preclinical data


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White Papers

ConsulTech GmbH

ConsulTech GmbH

ConsulTech is a consulting company founded in 1992. Since then, we have been supporting biotech-nology, pharmaceutical and medical technology companies as well as research institutions with the entire process of setting-up and executing proposals for R&D projects. In projects funded by the European Commission, ConsulTech supports the coordinator by resuming administrative tasks allow-ing coordinators and partners to fully concentrate on the scientific and technical success of the pro-ject. We solve financial and administrative issues, organise meetings, take care of the timely delivery of milestones and reports and much more.
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Industry Events

6th Annual Cancer Vaccines Conference

27-28 September 2017, Copthorne Tara Hotel, London UK

Cancer Vaccines 2017: Overcoming hurdles to cancer immune response: Cell therapies, vaccine development and combination therapies. SMi Group is thrilled to present the 6th annual Cancer Vaccines conference, taking place on 27th & 28th September 2017 in Central London, UK. Overcoming hurdles to cancer immune response: Cell therapies, vaccine development and combination therapies.
More info >>

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