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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

BioIVT Webinar Will Discuss How to Optimize Microbiome Research

BioIVT, a leading provider of research models and services for drug development, today announced that it is hosting a webinar entitled “The Microbiome: Understanding Why Collection and Processing Matters” at 11 a.m. ET on July 25.
More info >>

White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
More info >>

Industry Events

Partnerships in Clinical Trials Europe 2018

27-29 November 2018, CCIB, Barcelona

Partnerships in Clinical Trials Europe is back – and bigger than ever. Europe’s most complete clinical meeting is bringing together 1000+ of the industry’s leading experts this November for it’s 17th annual gathering, and you’re invited!
More info >>

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