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International Clinical Trials

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Autumn 2015

   
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Comment from the Editor

From regulatory compliance to quality management, this edition of ICT offers a wealth of practical advice on the conduct and planning of early- and late-phase trials. Graham Hughes provides an introduction.
 
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REGULATORY
Regulatory Update

New EU Clinical Trials Regulation

Trial authorisations across Europe look set to be streamlined under the incoming EU Clinical Trials Regulation, which will also bring a host of other changes. Laura Brown at LB Training and Development Ltd outlines its scope and the key requirements.
 
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Regulatory & Business Practice
IND Submissions

State Side Transitions


As worldwide sponsors progress early studies to Phase 2, many turn their attention to the US market – submitting an IND application for FDA approval. While comparable with the clinical trial application in Europe, there are extra criteria and important differences to negotiate, as TKL Research's Roxanne Tavakkol explains.
 
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TRIAL MANAGEMENT
Risk-Based Monitoring

Quality Review

María Proupín-Pérez of PPH plus says that accurate early identification of main study risks is fundamental when choosing the most appropriate monitoring strategy – contributing to patient safety and quality control, while helping avoid hasty and unwelcome rescue measures.
 
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Trial Planning

Prep Work


Many life sciences start-ups leave it late to plan for the trial phase, risking design setbacks, regulatory delays and rising costs. Following the principle of 'earlier is better', Nuala Ronan from Databean offers some advice on how to plan an effective study strategy.
 
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Q&A: Human Factors Analysis

Site Specific

Human factors analysis has entered clinical research in the last 18 months, ICON's Clara Heering tells ICT, with sponsors starting to incorporate it into risk-based monitoring to help in risk mitigation at sites.
 
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Quality Management

Action Packed


Patricia Santos-Serrao of MasterControl questions whether clinical trial management systems go far enough, arguing that quality processes should be strengthened across the wider study spectrum – with CAPA a valuable tool to prevent and correct deviations.
 
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Late-Phase Studies

Post Haste


Taking a new drug beyond the highly controlled environment of a clinical trial, post-authorisation safety studies can provide ongoing safety information from real-world use. Jess Sohal at United BioSource Corporation has some tips on effective operational delivery.
 
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eCLINICAL
Business Intelligence

BI the Way

Access to critical study information through actionable visual business intelligence reports can yield considerable benefits to clinical trial performance and timelines, aiding decision-making and helping turn sites into high achievers. Craig Morgan at goBalto explains.
 
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eTMFs and Inspections

MHRA Inspections: How Ready Are You?

Cost savings and improved audit and inspection readiness continue to drive the adoption of electronic trial master files by sponsors and CROs, according to a new survey, with next-generation eTMF applications increasingly seen as a strategic asset. Rik van Mol from Veeva Systems reports.
 
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eClinical Technology

At the Source


From minimising transcriptions errors to the potential for virtually instant safety reviews, eSource is fast becoming the gold standard for source data generation – and a streamlining force for trial processes. Ann Neuer of Medical deScriptions for Clinical Ink has more.
 
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Clinical Trial Supply & Packaging
Falsified Medicines

Cracking the Code

Justin Schroeder from PCI finds parallels between the randomised codes long used in clinical trials and the broader serialisation requirements that pharma is rushing to meet to help combat counterfeit drugs.
 
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Supply Chains

The Last Mile 

Millions of miles are travelled as temperature-controlled shipments are carefully monitored en route to investigator sites and patients but, says World Courier's Sue Lee, preplanning and supply chain flexibility are particularly important as medicines make the last mile.
 
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THERAPEUTICS
Anti-Infectives

Human Resources


Human challenge studies, in which healthy subjects are deliberately exposed to a virus before treatment, are increasingly crucial in generating proof-of-concept data and optimising doses for field studies. Adrian Wildfire and Bruno Speder at SGS Life Science Services outline how they are evolving.
 
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Ethics & Risk Management
End Point

Choice Words

Health literacy is closely tied to informed consent for trials but, comments Graham Hughes, ensuring patients have enough information to enrol and be treated is far from straightforward.
 
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Training & Development
Translation

Think Global


Will future talent entering the clinical trials sector have the language proficiency and cultural experiences needed to run successful global studies, ponders Russell Goldsmith at Conversis Medical?
 
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Trial Design
Protocol Compliance

Easier with ePRO

Exco InTouch's Laurence Burke
examines how sponsors can use mobile ePRO technology to offset protocol complexity and tip the balance in favour of compliance – making life easier for trial participants and investigators, as well as helping ensure greater confidence in data quality.

 

 
 
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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

PCI Builds North American Clinical Sales Team

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