spacer
home > epc > Spring 2012
PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2012
   
Text
PDF
bullet
Marketplace & Business

Contract Manufacturing: China

Making Progress

Maxine K Fritz and Scott Tatlock at Becker & Associates Consulting, Inc explore the benefits of outsourcing to CMOs in China, and consider the essential criteria for selecting a manufacturing partner.

 
view
download pdf

Big Pharma: 2012 Forecast

Beyond the Patent Cliff

Nick Beckett at CMS Cameron McKenna provides an in-depth review of developments within the pharmaceutical industry over the past year, and considers the changes that 2012 may bring.

 
view
download pdf
Sponsor-CRO Partnerships

Room for Improvement

A presentation at the 2011 Partnerships in Clinical Trials event given by Uwe Schneider of Grünenthal GmbH considered the lack of change within the pharmaceutical industry over the last 12 years. Uwe Schneider and Graham Hughes report on the findings of this presentation.
 
view
download pdf

In Conclusion

As Time Goes By...

Graham Hughes considers how the pharmaceutical industry has developed over the last 30 years.

 
view
download pdf
bullet
Clinical Trials

 Adaptive Trial Designs

Evolution or Revolution

Adaptive trial designs offer the potential to reduce clinical development costs. Judith Quinlan at Aptiv Solutions explores the benefi ts of this revolutionary methodology.

 
view
download pdf
bullet
Legal & Regulatory

Social Media: AE Reporting

Taking the Plunge

The pharmaceutical industry has been reluctant to embrace the benefi ts of social media. Elizabeth E Garrard of Drug Safety Alliance, Inc explains that increasing regulatory guidance will help the industry to overcome its fears and utilise platform for adverse event reporting.

 
view
download pdf
Paediatric and Geriatric Drug Development: FDA Regulations

Age Concerns

Pete Joiner and Ken Phelps at Madeira Therapeutics explain how new FDA regulations will help to increase research into paediatric and geriatric drug development.
 
view
download pdf

Medical Writing: Responses to Authority Questions

Finding the Answers

Julia Fornjanic Klapproth of Trilogy Writing and Consulting breaks down the process of responding to marketing approval questions.

 
view
download pdf
bullet
Clinical Trials Supplies

Clinical Trial Supply Sourcing

Strategic Alliances

The globalisation of clinical research means that finding the right clinical trial supply sourcer is more essential than ever. Lekishia White at Multipharma suggests that assessing a potential partner’s capabilities is an essential part of this process.

 
view
download pdf
bullet
Drug Discovery, Development & Delivery
Neurology: Sleep-Related Disorders

Counting Sheep

The lack of treatments for sleep-related disorders is set to be overturned with the development of biomarkers, electroencephalograms and spectral analysis, as Hubert Bland at Surrey Clinical Research Centre explains.
 
view
download pdf
bullet
Reviews & Previews

Book Review

A Comprehensive Account

Graham Hughes reviews Global Clinical Trials: Effective Implementation and Management, edited by Richard Chin and Menghis Bairu.

 
view
download pdf

A Time for Change?

Graham Hughes reviews the November 2011 Partnerships in Clinical Trials conference.

 
view
download pdf
bullet
Paediatrics Special Focus: Clinical Development and Regulatory Updates

Spotlight: Paediatric Research

Joined-up Thinking

Emma Sala Soriano and Irmgard Eichler at the European Network of Paediatric Research, EMA (Enpr-EMA), and Peter J Helms of the Scottish Medicines for Children Network at Child Health, University of Aberdeen, explore the initiatives of the Enpr-EMA in the field of paediatric medicine.

 
view
download pdf

Paediatric Drug Development

Youth Movement

EMA-approved paediatric investigation plans now force pharmaceutical companies to think about how their drugs will affect children. Klaus Rose at klausrose Consulting advises outsourcing to paediatric specialists in the face of this requirement.

 
view
download pdf
bullet
Data Management & IT Solutions
Data Transparency

Whose Data is it Anyway?

Gareth Adams and Melissa Nezos at PRA discuss the recent calls for increased data transparency, and look at the effects of electronic documentation on the availability and ownership of clinical trial data.
 
view
download pdf
Electronic Data Capture: Oncology Trials

Performance Enhancement

Successful integration of modern electronic data capture (EDC) technology can help streamline complex trials. Emma Banks at Datatrial considers the benefits of adopting EDC, and how to meet regulatory requirements.
 
view
download pdf
Electronic Documentation: SMEs

On the Record

As electronic documentation becomes an increasingly necessary component of clinical trials, Rolf Marugg and Georg Mathis at Appletree AG present the options available for the small- and medium-sized enterprises.
 
view

Connected Health

Making the Connection

mHealth technology can offer greater trial flexibility, evidence-based results and increased patient adherence as Mark Evans of Adherence Science Ltd and Kavita Oberoi of Oberoi Consulting explain.

 
view
download pdf
bullet
LABS & Logistics
Logistics: Controlled Room Temperature Shipments

Specialist Solutions

Nathan Barnard at Biocair International considers the options for transporting temperaturesensitive products, and suggests that taking a risk management approach to selecting a logistics solution is essential.
 
view
download pdf
bullet
Regional Focus

Regional Focus: Indonesia

Partnership Potential

With a growing economy, vast patient pool and increasing number of clinical trial sites and specialists, Indonesia offers an attractive solution for global clinical trials, as Endang Hoyaranda of Prodia the CRO shows.

 
view
download pdf
Regional Focus: Ukraine

Ironing out the Creases

As the pharmaceutical market in Ukraine continues to grow, its position as a viable alternative to the west for conducting clinical trials has been strengthened by the development of anticorruption law, as Timur Bondaryev and Svitlana Postrygan of Arzinger explore.
 
view
download pdf
   
spacer



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

Clinical Trials in Russia Orange Paper: 1st Quarter 2014

Synergy Research Group

In summary, Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
More info >>

Industry Events

CPhI Worldwide 2017

24-26 October 2017, Messe Frankfurt, Germany

CPhI Worldwide, together with co-located events ICSE, InnoPack, P-MEC and FDF, hosts more than 42,000 visiting pharma professionals over three days. 2,500+ exhibitors from 153 countries gather at the event to network and take advantage of more than 150 free industry seminars. The exhibition covers every sector of the pharmaceutical market under one roof.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement