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home > ict > Autumn 2018

PUBLICATIONS

International Clinical Trials

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Charles River Laboratories Continues Commitment to Oncology Drug Discovery

Charles River Laboratories International, Inc. (NYSE: CRL) today announced new additions to the Tumor Model Compendium. Charles River’s Compendium provides access to a comprehensive collection of well-established tumor models for early-stage oncology research.
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White Papers

Changing Structural Landscape for Comparator Drug Supply

ADAllen Pharma

TransCelerate Biopharma is focused on advancing innovation in R&D, identifying and solving common R&D challenges and further improving patient safety, with the goal of delivering more high quality medicines to patients. In 2013, they announced its Clinical Trial Comparator Network initiative to show a mutual commitment to offer secure and rapid supply of comparator drug products. The aim of this article is to unpack the section on 'Comparator Drugs' and analyse the rationale for attempting to achieve their objectives.
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Industry Events

INTERPHEX 2019

2-4 April 2019, Javits Center, New York

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA). Dedicated to Innovation, Technologies and Knowledge, the show focuses on the entire product development life cycle.
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