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International Clinical Trials

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Spring 2012

   
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Dr Graham Hughes reflects on the importance of clinical trial sample storage.

 
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Regulatory & Business Practice

Quality Oversight Programmes

High Standards

Third-party quality oversight programmes provide sponsors with an impartial assessment of their study, which can help to reduce costs and ensure regulatory standards are being met, as John R Wilson Jr at Beaufort, LLC discusses.

 
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Medical Devices

Off to Market

Karen Lunde and Stephan Joeken of CERES, Clinical Evaluation & Research share their thoughts on how best to compile a clinical investigation report to gain CE approval for a medical device.

 
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Cancer Drug Development

Data is King

Todd Clark at Value of Insight Consulting explains how the requirements of the FDA approval process can aid the development of cancer drugs by gathering information on endpoints, timelines, populations and safety results.

 
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Clinical Trial Management

Clinical Trial Management

Efficient Beginnings

The development of comprehensive risk and contingency plans, as well as sound communication plans, is essential when setting up a global clinical trial, as Kellie Malloy at PharmaNet/i3 explains.

 
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Clinical Trial Outsourcing

Outsourcing

The Art of Listening

Maintaining an equal and open relationship between sponsor and service provider can help ease the clinical trial process and encourage innovation, as Andy Thurstan of MD Events explores.

 
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eCLINICAL

Electronic Document Management Systems

Know Your Numbers

Rhonda J Paz and Diandra Nuno-Salcido of GuideStar Clinical Trials Management suggest how the formation of a regulatory document can benefit from adopting the right electronic document management system.

 
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Clinical Trial Applications

Submission Statement

Helle Ørbæk and Lillan Rejkjær of IWA Consulting explain how electroniccompatible clinical documentation provides an efficient and cost-effective method for submitting regulatory documents.

 
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Clinical Trial Supply & Packaging

Clinical Trial Labelling

Designer Label

Global clinical trials pose considerable challenges to the labelling process. Pernille Smith of CCL Label Healthcare discusses the methods being employed to overcome these difficulties.

 
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PREVIEW

Phase 1 and 2a Clinical Trials

Graham Hughes reviews the key presentations on proof of concept and venture capitalism at the London conference.

 
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Sample Management Strategy

Learn how successful sample management can help support the development of new therapies at the Global Sample Management Benchmarking Symposium.

 
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Regional trials

Regional Trials: South-East Asia

SEA Power

Kenneth Lee and Helen Neal at PRA consider the growth of clinical research in South-East Asia, and suggest that understanding the unique challenges of the region is essential.

 
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Hardware Fulfilment

Tools of the Trade

Karen Harley of Bracket and Christopher Nightingale describe how knowledge of local restrictions and regulations is critical when shipping hardware for a clinical trial, helping to prevent costly delays to the study.

 
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Central Labs

Central Laboratories

Rising to the Challenge

As the clinical research sector expands and trials become increasingly complex, central laboratories must learn to adapt to new pressures, as Graham Hughes and Richard Barrett, Consultants in Pharmaceutical Development discuss.

 
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Metrics Champion Consortium

From Evolution to Revolution

Guy A Mascaro of the Metrics Champion Consortium explains the role that the organisation is playing in helping sponsors to improve the clinical research process.

 
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Trial Design

Adaptive Designs: Early Phase Trials

Keys to Successful Design

Denis Gossen and Dominique Demolle of Aepodia explain how, with adequate planning, adaptive trial designs in early phase research can help to improve accuracy and efficiency.

 
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Patient Recruitment and Retention

Post-Marketing Research

Planting the Seed

Post-marketing research (PMR) is growing in importance, with regulatory authorities increasingly requiring studies that confirm the ongoing safety of a newly-approved drug. Thomas Wagner of Trilogy Writing & Consulting advises on how to design a successful PMR plan.

 
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Patient-Friendly Trials

Home is Where the Trial is

Home trials can be difficult to set up, but Graham Wylie of the Medical Research Network suggests that these studies are worth the risk as they offer considerable benefits to patient recruitment and retention.

 
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Interview

Industry Interview

Thinking Allowed

ICT talks to Steve Cutler of ICON Clinical Research Services about his views on the clinical trials industry and how it might develop in the future.

 
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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

Zenith Technologies Launches Virtual Manufacturing System Training Service

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, has launched a new virtual customised training service to tackle critical gaps in industry manufacturing software and process training.
More info >>

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 >>

Industry Events

ASGCT 22nd Annual Meeting

29 April - 2 May 2019, Washington Hilton, Washington, D.C

The 2019 ASGCT Annual Meeting is expected to be the largest in Society history, eclipsing the mark set by the 2018 meeting just last year. Join more than 3,500 researchers, clinicians, advocates, and industry leaders in discovering the latest science and technology surrounding gene and cell therapy.
More info >>

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