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International Clinical Trials

ict
Summer 2011

   
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REGULATORY
Regulatory Update: Medical Devices

Under the Environmental Microscope

Matthew Townsend and José Cofré at Allen & Overy LLP highlight the key changes in the revised Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive, describing how they will affect the medical devices sector.
 
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CLINICAL THERAPEUTICS
Personalised Medicine

Pipeline Potential

Put simply, the aim of personalised medicine is to get the right drug to the right patient.This depends on our ability to match our growing understanding of disease biology with the identification of suitable therapies, which in turn should be matched to the relevant patient, explains James Sawyer of Prism Ideas.
 
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Monoclonal Antibodies

Flow Cytometry and Clinical Trials

Carla G Hill and Thomas W McCloskey of ICON Central Laboratories provide an insight into the future of medicine, and how a combination of small and large molecule compound therapies, cellular biomarkers and flow cytometry will play a role in clinical development.
 
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PREVIEW
Event Preview

Five Shows, One Vision

CPhI Worldwide, ICSE, InnoPack, BioPh and P-MEC Europe will take place at the popular Messe Frankfurt exhibition centre in Germany, from 25th to 27th October 2011.
 
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Regional trials
Data Centre in China

Tales from the City

You might think that if you know how to conduct clinical trials in one country, you’ll also have success in another.However, Bruce D Schatzman of StudyManager explains that even with vast experience and technical knowledge, some challenges will simply not be anticipated.

 
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Translation in Africa

Speaking the Language

According to Unesco, around 2,000 different languages are spoken in Africa; however, there is a shortage of translators, which can make clinical trials on the continent challenging. Simon Andriesen at MediLingua investigates how CROs and international organisations are dealing with this problem.
 
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
Digital Pens and Paper Technology

Data Dynamics

Despite the rise of electronic applications, a large amount of clinical trial data is still being collected using paper-based methods.However, digital pen and paper (DPP) is now being adopted as a user-friendly and more accurate alternative, as Petter Ericson at Anoto AB explains.
 
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Interim Analyses

The Profitable Pause

David Underwood at Quanticate demonstrates how the Bayesian statistical framework can be used to plan and execute interim analyses – a process that is useful in making decisions about continuation versus early stopping of clinical trials – thereby improving the likelihood of success.
 
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Data Mining

Drilling Down to Success

Combining systematic analysis using data mining technologies with the critical insight of clinicians will help to increase success rates and diminish risk in clinical trials, as Mohammad Afshar and Lilia Abtroun of Ariana Pharma elaborate.
 
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Subject Payment Systems

Put it on the Card

A cost-effective method of payment to clinical trial participants can significantly improve subject retention rates – particularly when faced with the microwave mentality of ‘want it fast,want it now’. Samuel Whitaker at Greenphire discusses how new web-based payment solutions can help.


 
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Telemedicine Technologies

Moving Data, Not Patients

Significant savings and efficiencies can be achieved by implementing an electronic interface between the sponsor, investigator and patient. Erik J Fransen of Vitaphone Telemedicine explains the benefits that can be accrued in this relatively unexplored area of clinical trials.
 
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eCRFs

Promises, Promises

Despite the potential of eCRF, the platform can increase costs and make clinical research management more complex if not applied properly. Andrea DeRosa of Airon Telematica (Air-Tel) stresses that professionals will need to let go of old procedures and embrace new technologies in order to see significant benefits.
 
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Central Labs
Central Labs: Data Management

Entering the Atomic Age

Hacene Mekerri of Clearstone Central Laboratories examines the different phases in the evolution of data exchange and flow, envisioning a future which allows data managers, aided by the most sophisticated applications, to focus their time on the bigger picture.
 
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Central Labs: New Technologies

Seamless Integration

In the past 15 years, data produced by centralised laboratories has represented more than 60 per cent of all data submitted in new drug applications, and this percentage is expected to approach 80 per cent within the next few years. John Blakeley of ERT discusses the future of centralisation with a particular focus on cardiac safety.
 
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Business Practice
Translational Science

New Saviour

Simon Beaulah, Paul Denny-Gouldson and Robin Munro of IDBS describe how opportunities for successful collaborations between academia and industry partners in stratified medicine research can be greatly enhanced with the use of collaborative research platforms.
 
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Risk Management

Right Place, Right Time

In the increasing complex world of clinical trials, incorrect management of risk can have severely detrimental effects on the entire study.Active risk management is important in order to achieve cost-effective and better quality results explains Guy Patrick of Centrical Global Limited.
 
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Training & Development
Investigator Site Training

Synchronised Learning

Brendan Buckley at Firecrest Clinical argues that the current design of a typical investigator meeting is not conducive to interactive learning, suggesting that a hybrid model of training via shorter, regional and more principal investigator-focused meetings is a much better way to learn.
 
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Reviews
Book Review

The Ethical Code

Graham Hughes reviews On Moral Grounds: Lessons from the History of Research Ethics by Allen Gaw and Michael HJ Burns.
 
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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

Mironid Announces Closing of £4.3 million ($6.2 million) Series A Financing

Cell signalling in drug development company today announced the closure of its Series A funding round
More info >>

White Papers

Wrap Around Label - A Lot of Content in a Small Space

Faubel & Co. Nachfolger GmbH

One of the world’s largest contract research organizations for the planning and conducting of clinical trials was faced with the challenge of accommodating many different national languages on an inhaler. The inhaler was then to be distributed in 47 countries. Due to the impressive quality and reliable collaboration, the organization commissioned Faubel with finding the optimal labeling solution for the inhaler.
More info >>

Industry Events

PPMA Show 2017

26-28 September 2017, NEC, BIRMINGHAM UK

The PPMA is the UK's trade association for suppliers of processing and packaging machinery to the UK market and represents over 500 member and associate companies. Its principle objective is to promote sales of machinery, both at home and abroad, through various projects and services of mutual benefit to both members and their customers by providing free technical and machinery information and advice.
More info >>

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