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PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2014

   
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Keynote
Editor’s Letter

Casting his eye over the drug safety and patient recruitment articles in this edition, Graham Hughes reflects on the need to evolve relationships, both with industry partners and patients.
 
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Business and Finance
Financial Technologies

Cause for Control


With fragmented and manual payment processes a continuing burden for trial partners, Linda Drumright at IMS Health and Greenphire’s Sam Whitaker highlight closed-loop payment optimisation techniques that can better manage investigator budgets and complete the payment cycle.
 
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Marketplace & Business
Sponsor-CRO Collaborations

Double Impact


With the demands of global biopharma hitting unprecedented levels, the need to truly evolve the sponsor-CRO relationship and shed reliance on traditional, limited outsourcing models is becoming an imperative. Andrew Townshend and Judy Swilley at INC Research report.
 
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Strategic Collaborations

Kinks in the Chain


Beverley Flynn at Stevens & Bolton LLP emphasises the need for a flexible and integrated approach in order to assemble an efficient, high-quality supply chain between third-party manufacturing, R&D, logistics and warehousing.
 
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Clinical Trials: Patient Recruitment & Retention
Trial Recruitment

A Rare Find

Recruitment and retention can be a hard task for most clinical trials, but when the study area is an ultra-rare disease like alkaptonuria, every patient really does count, says Hana Ayoob at the AKU Society.
 
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Clinical Trials
Global Clinical Trials

Think Big

Operating in a global landscape means that clinical research has to consider a host of issues around ethics, contracts, logistics, start-up and data collection, says Rick Morrison from Comprehend Systems.
 
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Legal & Regulatory
EU Pharmacovigilance

Recent Developments

Shuna Mason
of CMS summarises the latest revisions to pharmacovigilance legislation, and other EU-led moves to accelerate and increase the updating of product and patient information with essential safety data.
 
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Annex 16: Revised

Quality First

Peter Gough
at NSF International navigates us through the European Commission’s draft revision of Annex 16, explaining the Good Manufacturing Practice changes to Qualifi ed Person responsibilities and batch release.
 
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Clinical Trials Supplies
Trial Drug Supply: APAC

Chain Reaction


Conducting trials in the Asia-Pacific is becoming more and more common, but the huge diversity of the region can lead to logistical problems. Kevin Cheong and Michelle Foust at Almac explain why selecting the right partner is essential to achieving effi ciencies.
 
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Electronic Solutions
Compliance Programmes

Do the Right Thing


Pharma invests heavily in compliance, and yet it is still no stranger to scandals and government investigations. Seth Berman at Stroz Friedberg discusses how tailored training, policies and software can help reinforce a culture of compliance from the top down.
 
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IT Solutions
Signal Detection

Sign of the Times


The benefits of a visualisation platform in signal detection can be significant. PRA’s Jacinta Aniagolu-Johnson explores how they can bolster routine and ad hoc review methods through simultaneous signal screening of individual case safety report and aggregate data.
 
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Science & Innovation: Asthma Focus
Asthma Management

Breathe Easy


Some 30 million people in Europe suffer from asthma, yet treatments are not always appropriate for the breadth of symptoms and sub-types. Samantha Walker at Asthma UK outlines the social costs and points to a new research partnership to galvanise collective expertise.
 
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Therapeutic Innovation: Cancer Focus
Automated Colony Analysis

Counting Costs

Michael Rau
from Oxford Optronix describes how CROs can use automated colony counting systems to resolve the capacity and scalability conundrum – ensuring they remain fl exible and costeffective in areas such as colony forming cell assays.
 
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DATA MANAGEMENT
Data Protection

A Safe Direction


New guidance aims to help pharma companies meet the often competing regulatory requirements of adverse event reporting and data protection. William Long at Sidley Austin outlines its recommendations and how it can be applied to everyday business practices.

 
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Risk Management
Business Protection

Risk Analysis


Large-scale outsourcing of research functions is predicted to transform the market over the next few years. Small- and medium-sized players are waiting to take advantage but, as Euan McKenzie of Central Insurance advises, there are both opportunities and risks to consider.
 
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Review
In Conclusion

No Kidding

Graham Hughes
comments on government plans to ban smoking in cars carrying children in England, and a call to update European requirements for paediatric trials.
 
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Interview
Industry Interview

The Extra Mile


From Microbiologist to Head of the Major Clinical Trial Unit, Sue Lee at World Courier tells EPC about her career and the push towards new markets.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Discussing developments on Highly Potent APIs with industry expert, Richard Arnett for the HPAPI USA conference 2019

Ahead of the 2019 HPAPI USA Conference taking place in Boston on 21st – 22nd October, SMi caught up with Richard Arnett, Manager, Industrial Hygiene, Pharmascience who is speaking on Day Two of the agenda. Richard shared his thoughts on how the industry has developed and briefly touched on what he will be discussing in October.
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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.
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Industry Events

2020 Avoca Quality and Innovation Summit

3-4 June 2020, Amsterdam, The Netherlands

The 2020 Avoca Quality and Innovation Summit will take place 3-4 June 2020, in Amsterdam, The Netherlands.
More info >>

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