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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

BioGenes Establishes Scientific Advisory Board

Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production and a global leader in host cell protein (HCP) assay development, today announces the establishment of a Scientific Advisory Board which includes the following four renowned experts:
More info >>

White Papers

Migration safe pharmaceutical labels improve patient safety

UPM Raflatac

Labels play an invaluable role on pharmaceutical packages. Pharmaceutical companies should only use labels that meet low-leachability and extraction requirements. Labels that are not migration safe, e.g. create leachable chemical compounds, may fail testing and result in significant launch delays or costly recalls. This white paper presents how pharmaceutical companies can ensure that the final label constructions achieve their business, regulatory and patient safety goals.
More info >>

Industry Events

12th Annual Paediatric Clinical Trials

19-20 March 2018, Copthorne Tara Hotel, London, UK

SMi is pleased to present the return of their 12th annual Paediatric Clinical Trials Conference taking place on 19th 20th March 2018, London, UK.
More info >>

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