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International Clinical Trials

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Spring 2016

   
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Editor's Comment

Graham Hughes
introduces this issue by outlining the two sides of clinical trial data – transparency on the one hand, and protection on the other hand – among other topics.

 
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Clinical Trial Management
Site Activation

Head Start


First and foremost, each clinical trial needs to undergo site activation – which can be a lengthy and tiresome process, says Melissa Easy at DrugDev. There are, however, three models at hand using the most recent technology to help facilitate trial start-up.

 
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Paediatric Trials

On Your Doorstep


With paediatric trials becoming more common, Dr Graham Wylie at MRN states that home visits in particular are part of an increasingly patient-centric healthcare movement.


 
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MARKETPLACE
End Point

Activity Surge

Graham Hughes
reports on the increasing activity in M&A over the past few decades, and outlines reasons for merging and the implications for consumers and stakeholders.

 
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Marketing Applications

The Final Step


Representing the last hurdle in bringing a drug to market, marketing applications can be costly and time consuming to develop. Rho’s David Shoemaker presents different application models to facilitate this procedure.


 
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Regional trials
Regional Trials

Across the Globe


ICT takes a closer look at the clinical trial landscape in different markets – namely Latin America, the MENA region, Indonesia and finally, in the EU.

 
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Latin America

Susana Bule and Cláudia Carvalho at Eurotrials reveal that the Latin American market has been demonstrating great potential for clinical research and pharmaceutical development for some years now. The spending in healthcare has also been increasing, which shows the governments’ prioritisation of this matter.


 
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The Middle East and North Africa

Cellia Habita at ARIANNE explores clinical trials in the Middle East and North Africa, and explains why these areas should not be neglected in favour of more familiar countries.

 
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Indonesia

Rutger Oudejans at UBM EMEA highlights the importance of local expertise in Indonesian clinical trials, and describes why this region has gained significant value in pharma as a whole.

 
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European Union

Srikanth Venkataraman
at Frost & Sullivan explores patient recruitment for global clinical trials – with a focus on the EU – which he believes are going to be transformed by digital platforms and mobile technologies.

 
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data management & statistical analysis
Data Protection

Under Wraps

8MAN’s Jens Puhle
believes that keeping data safe from rival organisations and potential theft is paramount in pharma – with threats being closer to home than one might think.

 
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Clinical Trial Data

Access Denied

Graham Donaldson
at TRAC Services looks at the transparency of data versus the protection of commercially confident information in light of the latest regulations introduced to Europe.

 
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Data Analytics

The More, The Merrier


There is no doubt that data plays an important role in pharma – and with a growing focus on the patient in the form of personalised medicine and services, this role is set to further expand, states Wipro Ltd’s Nitin Raizada.

 
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Data Formatting

Preparing for SEND

Roman Radelicki
at SGS believes that implementing the standardised electronic format SEND can help streamline the process of submitting electronic data in non-clinical studies, and can further save time and money.

 
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Drug delivery & Therapeutics
Rare Disease Treatment

Making a Difference

World Courier’s Sue Lee
discusses the growing importance of orphan drugs, which must be produced in small quantities for a limited patient population, and questions the fact that only 5% of rare diseases have treatments available.

 
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Supply Chain & Manufacturing
Clinical Supply Chains

On Demand


Adaptive trial design is becoming increasingly popular, observes Catalent’s Dr Paul Ingram, before investigating its implications on supply chain efficiency.

 
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Logistics and Handling

Touch Point

Essangui Mbaitjongue
at Thermo King is convinced that with the help of tighter temperature guidelines, the shipment of pharmaceuticals can be facilitated – thus enabling them to reach their destination unharmed.

 
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Central Labs
Microbiological Labs

Driven by Results: Part 2


Olga Sazonova, Veronika Khokhlova, Maxim Belotserkovsky
and Andrey Karelin at PSI CRO continue examining quantitative urine culture studies, and consider country-specific differences.

 
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Cancer Therapeutics
Pharmacogenomics and Oncology

Special Treatment

United BioSource Corporation’s Dr Don Gabriel
outlines the implications of the use of pharmacogenomics – the study of individuals’ genetic variations – on oncology, and how that impacts the way patients respond to medication.


 
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Oncology Research

Relationships Matter

Dr Martin Lachs
at ICON examines the connection between sites and CROs when enrolling patients in oncology studies, and considers how to further improve this relationship.

 
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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

YHEC announced appointment of Stuart Mealing as Associate Director of Health Technology Assessment

YHEC is pleased to announce the appointment of Stuart Mealing as Associate Director of Health Technology Assessment. Stuart will be leading the YHEC economic evaluation and modelling team. Stuart has a Master’s degree in operational research from the University of Lancaster Business School and a post-graduate certificate in international business management from Smurfit Business School, Dublin.
More info >>

White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
More info >>

Industry Events

CPhI India 2017

27-30 November 2017, Bombay Exhibition Centre & MMRDA Grounds, BKC

Connect, network and interact with 1,400+ exhibitors at India's largest and leading pharmaceutical event. CPhI and P-MEC India is the gateway for you to meet the movers and shakers in India’s pharma industry to source high quality pharma solutions at the most competitive prices. Register today for free via: gotocphi.com/india2017
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