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International Clinical Trials

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Autumn 2016

   
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Editor’s Comment

From risk-based monitoring to mHealth developments, this edition of ICT combines current topics in the clinical trial landscape. Graham Hughes comments on the most prevalent themes.
 
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Clinical Trial Management
Paperless Monitoring

Keeping Tabs

Jan Klint Nielsen
at BSI discusses the role of clinical trial management systems in the conduct of studies, and the positive effect they might have on trial operations as a whole.
 
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Clinical Trial Outsourcing
CRO-Pharma Collaboration

Does Size Really Matter?


Outsourcing is becoming an increasingly attractive option for pharma companies looking to delegate their trial operations. Mohamed El Malt at Europital reveals why choosing smaller CROs does not necessarily leave sponsors at a disadvantage.
 
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Clinical Trial Supply & Packaging
Clinical Supplies

Future Vision


Forecasting and simulations are, according to Praveen Chand at Cenduit, a reliable way of planning the near-exact amount of clinical supplies needed for a trial, which can help facilitate this complex task.
 
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Just-In-Time Labelling

A Question of Standards


Labelling drugs is as important as the package used to store them – with both playing a critical part in patient compliance, states Faubel Pharma Services’ Nurdan Citamak.
 
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Regional trials
Asia-Pacific Trials

Changing Face

PCI Clinical Services’ Rich Nelson
explains the increasing shift from conducting investigational studies in Western countries to the Asia- Pacific region, and highlights marked differences in regulatory and logistical risk.
 
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Regional Focus: India

Credibility Crisis


The reputation of Indian drug makers has been hit hard by rising levels of concern about their manufacturing practices, observes Vivek Chaturvedi at Hitachi Consulting. He examines possible reasons for these doubts.
 
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Clinical Trials in India

Making a Comeback


India is an attractive location for studies looking for access to a wider population base and ethnic diversity of potential subjects, among other benefits – yet a decline in CTA approvals is telling a different story. Pharm-Olam’s Thanuja Naidu outlines how regulatory authorities are addressing this issue.
 
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Ethics & Risk Management
Risk-Based Monitoring

What’s the Risk?


To improve subject safety and data quality in the drug development process, an RBM approach is required – which also helps to reduce costs, claim Greg Ambra and Jean Battikha at DZS Clinical Services.
 
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Human Factor Analysis

Lessons Learned


Clara Heering
at ICON believes that employing human factor analysis has the potential to radically improve trial efficiency through a better approach in the identification of risks and errors.
 
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Supply Chain & Manufacturing
Global Supply Chains

The Complete Journey

PAREXEL’s Andrea Zobel
takes us through the entire drug supply chain stages – from the initial planning and manufacturing, to distribution and dispensing to patients.
 
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End Point

Can You Resist?


ICT Editor Graham Hughes raises awareness about the fact that millions of lives are lost because of drug-resistant infections – but antibiotics are immensely difficult to produce.
 
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Patient Recruitment and Retention
Direct-to-Patient Model

Coming to You


World Courier’s Sue Lee
wonders if the concept of bringing the trial to the patient – rather than the other way around – could be the solution to ongoing recruitment and retention challenges.
 
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mHealth and Patient Engagement

Get Involved


Clinical Ink’s Kyle Hogan
investigates the connection between mobile devices, protocol compliance and patient retention.
 
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Interview
Q&A: Event Preview

Communication is Key

Naomi Brooker
talks to ICT about the main themes of the upcoming Partnerships in Clinical Trials Europe event in Vienna, Austria.
 
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Digital Advances
mHealth Solutions

Are You Mobile?

Nancy Mulligan
and Patrick Prugh at UBC comment on the growing prevalence of mobile technology and mHealth apps in pharma, and consider the question of how and when to incorporate these in clinical trials.
 
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Medication Adherence

Deliverapp

Chris Evans
at West Pharmaceutical Services contemplates mHealth apps in the context of medication adherence in chronic disease patients, and why they can prove beneficial.
 
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Electronic Health Records

The Patient Chronicle


To reach the common goal of more efficient healthcare systems, it is imperative to integrate technology into patient registers. Martin Gibson at NorthWest EHealth talks about the numerous advantages that electronic health records could bring.
 
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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

Synpromics announces a research collaboration with GE Healthcare to extend the toolbox for production of biologics

Edinburgh, UK, 4th January 2017 – Synpromics Ltd, the leading synthetic promoter and gene control company, is pleased to announce a research collaboration with GE Healthcare to jointly develop customised synthetic promoters optimised for GE Healthcare’s proprietary biopharmaceutical manufacturing platform.
More info >>

White Papers

Pharmaceutical Companies: Outsourcing Combination Product Manufacturing

Phillips-Medisize

Combination products are therapeutics that combine two or more products (drug/device, biologics/device, biologics/drugs, or drug/device/biologics), regulated and sold as a single unit. Examples of combination products include drug-coated implantable devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
More info >>

Industry Events

ASPIRE: International EDGE Conference

28 February - 1 March 2018, The Vox Conference Centre, Birmingham

The ASPIRE international conference is taking place on the 28th February and 1st March 2018 at the Vox Conference Centre in Birmingham. The conference brings together members of the research community including research professionals from the NHS, Clinical Trial Networks and international organisations. The ASPIRE conference will allow delegates to share knowledge and best practise with the focus on enhancing the efficiency and productivity of clinical research across the UK and beyond.
More info >>

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