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PUBLICATIONS

International Clinical Trials

ict
Autumn 2011
   
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Editor’s Comment

Dr Graham Hughes explains why fixating on the impact of an ageing population on rising healthcare costs could be a dangerous red herring for policymakers.

 
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REGULATORY

Voluntary Harmonisation Procedure

A Better Deal in Europe

Interpretation and implementation of the EU Clinical Trial Directive has proved to be a complex task. Peggy Cance and Karen Goode at EUDRAC consider the role of the voluntary harmonisation procedure, which seeks to provide a coordinated assessment of multinational clinical trial applications.

 
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Clinical Trial Management

Adaptive Trial Designs

Looking for Answers

Andy Grieve at Aptiv Solutions explores the limitations of adaptive trial designs, and explains why detailed planning at the development programme level results in a more efficient clinical trial.

 
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Translation

The Right Message

María Azqueta Arizcun at SeproTec highlights the importance of translation of clinical trial documents for multinational trials, and emphasises the need for validation and an understanding of the cultural context to ensure that the messages are accurately conveyed.

 
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Medical Writing

Strategic Benefits

Medical writing often plays a secondary role in clinical trials, employed only to deal with the formatting of documents. However, as Julia Forjanic Klapproth at Trilogy Writing and Consulting explains, the medical writing process can contribute much more to the trial as a whole if specialist strategic medical writers are employed

 
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Comparators

Savvy Sourcing

Lekishia White at Multipharma Inc discusses the importance of selecting the right comparator for clinical trials, and offers a number of positive ways to successfully overcome the difficulties of this problematic but necessary process.

 
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eCLINICAL

Patient Reported Outcome

A Measured Decision

The opinions of patients are increasingly considered to be an important part of the assessment of a clinical trial. Keith Meadows of DHP Research & Consultancy Ltd explores the complexities of PROs and suggests an effective way of integrating them into the traditional clinical methods of measuring the effects of treatment on the patient.

 
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Patient Recruitment: Social Media

The Era of Digital Medicine

Social media is often utilised by the drug development industry for recruitment in order to engage with potential patients. KK Rumrill of BBK Worldwide discusses the most effective way to harness this platform, and how to overcome potential issues.

 
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Regional trials

Early Phase: CEE

Methods for Motivation

Clinical research organisations are increasingly turning to central and eastern Europe (CEE) as a location for conducting trials. Christian Reh at PRA discusses why the region’s unique centralised hospital structure is an advantage for patient recruitment and retention.

 
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Locating Clinical Trials: CEE

Growth Market

Suzanne Pozsonyi at SynCon International provides an insight into the reasons why Hungary’s patient pool and commitment to maintaining international standards has helped the country to become a reliable research location.

 
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Biotech Pipeline: CEE

Developing Locations

Natalie G Harris and Anthony Southers at Ockham explain the need for companies sponsoring trials in CEE to have an understanding of the country in which the trial being conducted, and suggest that the most effective way to gain this knowledge is through the employment of local experts and the use of electronic data capture.

 
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Medical Imaging: CEE

Picture of Perfection

Richard Walovitch and Richard Taranto at WorldCare Clinical discuss the growing number of clinical trials taking place in CEE, and the need for these countries to consider the importance of standardised medical imaging systems as this growth continues.

 

 
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Oncology Trials: CEE

Fertile Ground

Andrei Kravchenko of Harrison Clinical Research explains how in Ukraine the healthcare structure and a large and enthusiastic patient population are contributing to this growing region in clinical research.

 
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS

Medical Imaging

Lines of Communication

Medical imaging plays an increasingly important role in clinical trials, but the transfer of information is not always seamless. Christophe Golenvaux of Lambda-Plus considers how e-platforms can best help with this process.

 
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Digital Pen and Paper

Mightier than the PDA

Electronic data capture is an efficient way of storing and processing clinical trials data. Subash Sadanandan at Greens Datamatica and Ken Ashman at Pharmanet i3 explain the benefi ts of upgrading to the digital pen and paper – a technology that allows for quick and easy transfer and sharing of data.

 
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THERAPEUTICS

Diabetes Therapy

Clamping Down

Glucose clamp technology has greatly advanced in recent years, allowing the tool to offer a new range of procedures and greater reliability. Clayton Dehn of ICON shows how these developments help to improve both patient treatment and the development of drugs to treat Type 1 and Type 2 diabetes.

 
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Labs & Logistics

Logistics: CEE

Act Local

Oksana Maksimova of Clinical Trials Logistics explores the benefits of conducting trials in Ukraine, focusing on the country’s clinical depots, which strive to meet international standards and regulations in order to compete with sites in the west.

 
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Supply Chain & Manufacturing

Risk Minimisation: Manufacturing

Regional Variation

Manufacturers face a number of hurdles when considering risk minimisation strategies as regulation is not consistent between countries. Terri Madison at Xcenda compares the US and EU approaches and advises the best way for companies to overcome the challenges that this variation poses.

 
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Business Practice

Budgeting

The Long Road Ahead

Lori Shields at Medidata Solutions Worldwide suggests that a faster budgeting agreement between site and sponsor can lead to increased revenue, and offers a number of solutions to the potential budgeting issues between sponsors and trial sites, as developments in technology have allowed both parties to operate more efficiently.

 
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Training & Development

GCP Training

Online Lessons

It is essential that the staff involved in a clinical trial receive sufficient training to ensure the trial is conducted correctly. Sabine Veigel and Andreas Grund at GCPService International provide a comparison of the effects and popularity of face-to-face and online training.

 
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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

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