spacer
home > ict > Autumn 2018
PUBLICATIONS

International Clinical Trials

ict
Autumn 2018

   
Text
PDF
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
TRIAL MANAGEMENT
 
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf

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.
 
view
download pdf

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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
 
download pdf

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.
 
view
download pdf
bullet
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.
 
view
download pdf
   
spacer
Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Are you keeping up to date with changes to pharmaceutical laws and guidance?

The legal and regulatory environment affecting the pharmaceutical industry is in a period of unprecedented change. Are you keeping up with all these changes?
More info >>

White Papers

Bonfiglioli Engineering Headspace Gas Analysis Systems for Parenteral Manufacturing Processes: One Step Beyond Product Quality and Patient Safety

Bonfiglioli Engineering

This white paper presents the innovative solutions that Bonfiglioli Engineering has been developing in the field of HGA and their significant advantages over other existing systems.
More info >>

Industry Events

Pharma Packaging and Labelling East Coast 2019

20-21 February 2019, Phildaelphia, USA

Now in its 11th year, Pharma Packaging and Labeling is back to deliver key, actionable insights into very latest regulatory requirements, technological innovations, strategic developments, and how to implement them into your packaging and labeling chain with both maximum efficiency and minimal cost.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement