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International Clinical Trials

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Autumn 2018

   
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REGULATORY
The GDPR Impact on Data Management

Reviewing the Rulebook

Kaia Koppel and Agnieszka Felicjanczuk at KCR reflect on the implementation of the General Data Protection Regulation and speak about the consequent impacts that are beginning to show themselves.
 
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Regulatory & Business Practice
Developing a Pharmacovigilance Presence in Japan

Planning and Execution

A great deal must be be considered when expanding and developing a pharmacovigilance presence in Japan. The team at PPD and PPD-SNBL delve into the intricacies of this essential challenge.
 
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TRIAL MANAGEMENT
 
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Clinical Trial Outsourcing
Outsourcing and Vendor Management

Does Size Matter?

Heike Schön at LUMIS International reviews outsourcing during the early stages of clinical trials, providing an insight into what to look for when wrestling with budgets and resources.
 
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eCLINICAL
Digital Technologies in Clinical Research Networks

Clinical Connectivity

Andreas Walter and Le Vin Chin at Clinerion discuss modern technologies and how they are being utilised across the clinical research industry to speed up processes and deliver higher quality results.
 
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Ethics & Risk Management
Pharmacovigilance in the EU

Quality Upkeep

Some complex requirements must be met to establish a pharmacovigilance system, particularly when it comes to products and patient safety. David Hukin at Quanticate explains more.
 
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Approvals for Gene-Based Therapy

Navigating Through Uncharted Waters

Medical advancements are commonplace in gene-based trials, but several challenges need to be overcome. The team at Worldwide Clinical Trials explore the safety and ethical side of these specific trials.
 
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Cancer Therapeutics
Transforming Cancer Outcomes with Real-World Evidence

Capturing Cancer Evidence

With the ever-evolving measures surrounding patient-reported outcomes, providing the best services to patients is critical, as explained by Dr Tim Williams at My Clinical Outcomes.
 
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Trial Design
Q&A: An Integrated Approach to First-In-Human Trials

Clinical Complexities

Torkel Gren at Recipharm and Anders Millerhovf at Clinical Trial Consultants spoke to ICT about the differing complexities of first-in-human trials and advise on how to craft an effective journey to market.
 
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Unifying Clinical Operations

Streamlining Start-Ups

Veeva Systems’Rik Van Mol describes how clinical leaders across the industry are beginning to understand the benefits of unification for clinical operating environments and how strategies are being attained.
 
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Q&A: Adaptive Trials

Modifying Methods

Dr Sy Pretorius at PAREXEL offers his insight to ICT about how the utilisation of adaptive trial design can improve data collection, as well as increase the chance of overall trial success.
 
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Patient Recruitment and Retention
Patient Travel Assistance

Talking Travel

Hannu Koski and Rob Laurens at BBK Worldwide take a detailed look into the role that transportation can play to ensure patient retention and satisfaction across clinical trials.
 
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End Point
End Point

The Imminent Exit

ICT’s Editor, Dr Graham Hughes, looks ahead to the UK’s exit of the EU and what it may mean for clinical trials and medication in the following year.
 
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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

CPhI China opens with analysis pointing to a surge in growth in 2019

Shanghai, 23rd May 2019: New analysis released ahead of CPhI & P-MEC China (#CPhIChina and #PMECChina) – co-organized by Informa Markets, CCCMHPIE, and Shanghai Sinoexpo Informa Markets – forecasts that China will continue to grow strongly through 2019/20, thanks in part to a marked improvement in its global reputation.
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White Papers

Device Develop for Combo Products

Phillips-Medisize

Combination products are defined as therapeutics combining two or more products (drug/device, biologics/device, biologics/drugs or drug/device/biologics), regulated and sold as a single unit. As these pharmaceutical and biological therapies and treatments have evolved, so has the need to develop appropriate delivery mechanisms for these applications. When developing a combination product, there are many things that need to be considered – the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, as well as, device manufacturing variation.
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Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
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