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International Clinical Trials

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Autumn 2017
   
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Keynote
End Point
Cut Off
Dr Graham Hughes
looks to the financial side of clinical trials, wondering how exactly Brexit might affect the pharma and healthcare industry's funding.
 
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Clinical Trial Management
Improving Site Activation
Three-Fold Solution
Sean Stanton
at Bioclinica Research Network believes that proper leadership and oversight can protect site start-up from delays and complications caused by miscommunication between the large number of parties involved.
 
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Site Selection and Management
Important Choices

CIDP’s Bandana Seesurn acknowledges the difficulties in choosing a trial site, but also looks at the current resources simplifying this process, such as online platforms and other modern communication technology.
 
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eCLINICAL
eSource at the Sites
Revolutionary Potential

Mike Novotny and Nick O’Brien at Medrio discuss the difficulties of getting site staff to adopt new methods and technologies that could eliminate paper practices and provide excellent benefits.
 
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Patient Consent Practices
Shredding Paper

DrugDev Patient Solutions' Eric Delente discusses the integration of eConsent methods into trials in place of out-dated paper consent forms, acknowledging patient empowerment and ease of understanding as key benefits.
 
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Pharmacovigilance Online
Time to Listen

Caroline Legendre and Alexis Pinçon at UBC consider the integration of new technology into pharmacovigilance practices and how platforms offering unique opportunities to hear the collective voice of patients are growing in importance.
 
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Clinical Trial Management Systems
The Connected CTMS

Utilisation of the cloud could reduce expenses and aid process efficiency, solving the problem of increased study complexity caused by the rising number of data sources, suggests Brion Regan at ERT.
 
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PREVIEW
Event Preview
Coming Together

In this introduction to PCT Europe 2017, we relay the topics that will be covered by experts on 28-29 November in RAI, Amsterdam.
 
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Regional trials
Japanese Clinical Research
Expert Knowledge

According to ICON’s Mary Pan, utilising CROs will overcome the hurdles that currently prevent Japan’s growth in the field of biopharmaceutical R&D.
 
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data management & statistical analysis
Digital Developments
Through the Clouds

Focusing on the use of new technology in data management, Mike Capone at Medidata Solutions shows how machine learning methods have become crucial to production processes thanks to the availability of computing power.
 
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Patient Recruitment and Retention
Site Nursing Support
Helping Hands

Improving standards of care is one of the pharma industry’s main goals, and it can lead to a rise in trial recruitment and retention rates. Helena Baker at Medical Research Network highlights how nurse visits are encouraging both.
 
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Interview
Q&A: PCT Europe 2017
Teaming Up

Conference Director Louisa Maitland talks with ICT about the upcoming PCT Europe event, which will offer insight into industry issues.
 
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Digital Advances
Electronic Medical Records
On the Record

Full digital provision of the right patient health information could enable precision medicine to significantly improve disease treatment, and IT is key to enabling this, say Tigran Arzumanov and Le Vin Chin at Clinerion.
 
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Spotlight
elluminate® Mapper

This issue’s Spotlight feature is presented by eClinical Solutions, outlining innovations in data management tools that are allowing clinical development teams to become more self-sufficient.
 
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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

Sustainability, plastics and Brexit: Keynote speakers set to inspire at PPMA Total Show 2019

Experts from IKEA, the British Plastics Federation and The Sunday Times to create a forum for education, knowledge-sharing and debate
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

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