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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

Drive for generics sees Korea increasingly attractive to international pharma

Amsterdam, 31st July 2019: Already home to more than 40 pharmaceutical multinationals, Korea is on course to become a global biotech and pharmaceutical hub by 2025, driven by the surge of international partnerships, biosimilars, an expansion in the export of finished formulations and a robust generics market.
More info >>

White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
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Industry Events

2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
More info >>

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