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European Pharmaceutical Contractor

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Summer 2012
   
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Marketplace & Business

Business Management

Big Pharma in Crisis?

Despite the challenges the industry currently faces, Big Pharma is looking for new ways to render the drug development process more efficient and sustainable, as Chris Swain of Cambridge MedChem Consulting discusses.

 
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UK Survey

Life Science Expectancy

Nick Stephens at RSA explores the results of the UK Life Science Industry Leaders Survey, highlighting disappointment at the Government’s lack of support for the industry and the areas with potential for growth.

 
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Pain Management Therapeutics

In Search of Relief

With an ageing population and promising new treatments in the pipeline, the pain management market is set to continue its growth. Swapna Soni at GBI Research highlights the key trends in this sector.

 
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Clinical Trials

Strategic Outsourcing: Clinical Trial Management

Changing Landscapes

Outsourcing the management of a clinical trial can prove to be a beneficial strategy. Tom Avery at ERT considers the pros and cons of such an approach, with reference to respiratory therapeutics and ePRO.

 
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Regional Trials: Asia

Find your Partner

As Asia continues to grow as a centre for international drug development, it can be useful to consider the benefits of working with a local CRO, as Young Jack Lee at LSK Global PS discusses.
 
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Feasibility Studies

Weighing up the Options

Alexandra Terzakis at SIRO Clinpharm suggests that a feasibility study is essential to the success of a clinical trial, incorporating regulatory considerations, patient recruitment expectation and any anticipated costs.

 
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Early Phase Trials: Oncology

Starting Blocks

As the field of oncology drug development continues to grow, Jane Bentley at Novella Clinical explores the best way to optimise Phase 1 clinical trials, from improving protocol preparation to monitoring data.

 
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Legal & Regulatory

Obesity Drug Development: FDA Guidance

The Heart of the Matter

Regina M Ballinger at Thomson Reuters provides an overview of the obesity drug market, and considers the regulatory guidance in relation to a number of potential new drugs in the pipeline.

 
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Observational Studies: Regulatory Considerations

Seeing Clearly

Providing real-world data for decision making, non-interventional studies (NIS) must still adhere to the relevant regulations. Rohini Chari at United BioSource Corporation explores the key considerations for setting up an NIS.
 
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US Pedigree Laws

Patchwork Approach?

US drug pedigree laws were established in order to combat the rise in counterfeit drugs. Dirk Rodgers of RxTrace.com examines these regulations and suggests that they need to go much further in order to ensure supply chain integrity.
 
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Drug Development & Delivery
Drug Development: Virtual R&D

A New Dimension

Karyn Korieth at CenterWatch investigates the development of new virtual research companies, which seek to overcome declines in productivity by adopting radical new methods for R&D.
 
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Reviews & Previews

Book Review

A Problem Shared

Graham Hughes reviews Portfolio Programme and Project Management in the Pharmaceutical and Biotechnology Industries, edited by Pete Harpum.

 
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Data Management & IT Solutions

Strategic Outsourcing: Data Management

An Evolution of Engagement

Greater involvement in the CRO-sponsor relationship, coupled with a consideration of the technology involved in research, can help both parties to remain competitive, as Graham Bunn at Medidata Solutions Worldwide explains.

 
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Cool Chain, Labs & Logistics
Supply Chain: Outsourcing

Turning Tide

Outsourcing logistics activities need not be as daunting a task as many pharmaceutical companies perceive it to be. Fabio Mioli at DHL Supply Chain discusses the benefits of working with a specialist supply logistics service provider.
 
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In Conclusion

Paying the Price

Graham Hughes considers the industry’s approach to drug pricing.

 
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Medical Writing

Regulatory Submissions

Re-Writing the Rule Book

Outsourcing the process of writing regulatory documents provides reliable expertise, flexibility and cost-efficiency, as James Sawyer at Prism Ideas explores.

 
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News and Press Releases

BioGenes Establishes Scientific Advisory Board

Berlin, Germany, December 12, 2017 / B3C newswire / -- BioGenes GmbH, specializing in ELISA development and production and a global leader in host cell protein (HCP) assay development, today announces the establishment of a Scientific Advisory Board which includes the following four renowned experts:
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White Papers

Migration safe pharmaceutical labels improve patient safety

UPM Raflatac

Labels play an invaluable role on pharmaceutical packages. Pharmaceutical companies should only use labels that meet low-leachability and extraction requirements. Labels that are not migration safe, e.g. create leachable chemical compounds, may fail testing and result in significant launch delays or costly recalls. This white paper presents how pharmaceutical companies can ensure that the final label constructions achieve their business, regulatory and patient safety goals.
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Industry Events

Outsourcing in Clinical Trials Southeast 2018

13-14 March 2018, Durham, North Carolina

This year’s Outsourcing in Clinical Trials event builds on last year’s incredibly successful conference which will once again be returning to North Carolina with the aim of supporting trial sponsors and solution providers in the RTP and neighboring regions, ensuring trials are delivered on time and partnerships are bettered.
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