International Clinical Trials |
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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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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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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 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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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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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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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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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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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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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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