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PUBLICATIONS

International Clinical Trials

 
International Clinical Trials (ICT) is a specialist journal designed to provide global coverage of key topics pertinent to the clinical trials sector.

Published quarterly, and edited by Dr Graham Hughes, the journal offers a platform of communication and information-sharing for executive and strategic decision-makers, seeking out new trends and marketing opportunities, as well as putting a spotlight on the latest innovations coming to market. ICT is specifically designed to be of interest to those actively seeking to source services for improved efficiency in what is an increasingly competitive market.

 
For further information please contact:

Advertising
Nick Matthews   

Editorial
Rupert Gilbey

Connect with us on Twitter: follow @IntClinTrials

Read our publications on the go in the Samedan app for iPhone and iPad. You can download issues for offline reading and our archives go as far back as 2008! Download for free on the App Store.


View the digital version of ICT

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Featured in this issue
Introduction
Editor’s Comment

Introducing this edition of ICT, Graham Hughes draws on the themes of small and medium-sized pharma – from the independent CRO scene to eClinical efficiencies for smaller sponsors – and the complex demands of supply logistics.
Regulatory & Business Practice
Pharmacovigilance

Applied Science


UBC's Véronique Basch provides an overview of the EMA's application process for new drugs, stressing that marketing authorisation holders must be at pains to make sure that safety and regulatory documentation is properly prepared and consistent.
  PREVIEW
PCT Europe: Q&A

Out and About

From disruptive innovation to the latest in strategic collaborations, the Partnerships in Clinical Trials Congress Europe is the ideal meet and greet event for clinical outsourcing, says Informa's Rosie Bernard.

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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

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Industry Events

Clinical Trials in CNS

11-12 November 2014, Marriott Regents Park Hotel, London, UK

SMi is delighted to announce its 13th annual Clinical Trials in CNS Conference. With an ever increasing average life expectancy, neurodegenerative diseases are becoming more prevalent in society.
More info >>

 
News and Press Releases

Nature-Identical Hydroxytyrosol for Dietary Supplements and Cosmetics

At SupplySide West 2014, WACKER is premiering its nature-identical hydroxytyrosol for applications in the food and cosmetic industries.
More info >>

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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>

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