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International Clinical Trials

ict
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
Continuity of Patient Care Post Trial

Clinical Trials in Cyberspace

Dr Jennifer Riggins at Eli Lilly and Dr Sandra Blumenrath at DIA assess the growth of digital devices and wearables and the different methods being used with new technologies to enhance the level of care for patients.
 
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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

Sharp announces preferred partner agreement with Berkshire Sterile Manufacturing

Sharp, a global leader in contract packaging and clinical supply services, part of UDG Healthcare plc, has confirmed a preferred partner agreement with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM).
More info >>

White Papers

Quality By Design

Biopharma Group

Quality by Design (QbD) is a systematic approach to development that begins with the defined objectives and emphasizes science and quality risk management in order to achieve those goals. QbD ensures that the quality of the product is built into production processes from the outset, rather than being tested after development has already commenced.
More info >>

Industry Events

10th Annual Summit for Clinical Ops Executives

18-21 February 2019, Hyatt Regency Orlando, Florida

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including...
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