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European Pharmaceutical Contractor

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Autumn 2011
   
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Marketplace & Business

CRO Strategic Partnerships

Budding Relationships

Karyn Korieth at CenterWatch discusses how using performancebased metrics in site selection can help CROs to establish long-term relationships with those sites who are capable of delivering high-quality clinical data faster and more efficiently.

 
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Annual CRO Review

The Race Towards Strategic Outsourcing?

EPC’s Editor Graham Hughes reviews the CRO market in 2011, placing a strong emphasis on mergers, acquisitions, joint ventures and strategic alliances as an indication of what is to come in the industry.

 
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Translation: In-Country Review

Problems and Best Practices

Translations can be a sticky process,with both the actual translation and the review being time-consuming processes. Simon Andriesen of MediLingua gives us the do’s and don’ts that reviewers should bear in mind, as well as the ways in which the process can be streamlined.
 
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Multiregional Clinical Trials

Sourcing Comparators

Sourcing comparators for domestic clinical trials has its own challenges; when conducting global trials there are even more hurdles to overcome. Lekishia White of Multipharma, Inc describes factors to consider when choosing a comparator.
 
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Clinical Trials: Patient Recruitment & Retention

Clinical Patient Databases

The Population Pool

Efficient patient recruitment is one of the greatest challenges to clinical trial sponsors and can often cost many months in valuable research time. Joseph Azuri at Maccabi Healthcare Services explains how patient databases can be used to define the optimal subject population.

 
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Patient Recruitment: Europe

Pick and Mix

Selecting the right media platform for the recruitment of study participants in Europe depends on the individual indication and criteria of the clinical trial.Whatever the method, it is important to present enough information to provide answers to the most frequently asked questions, states Nils Drew at Clariness.

 
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Legal & Regulatory

Regulatory Viewpoint: India

Firm Foundations

The Indian pharmaceutical industry is the third largest in the world in terms of volume and is currently valued at about $400 million. While this is a great milestone for the region, a strong regulatory framework is essential in order to avoid losing momentum, assert Ajit Nair and Rajendra Talele of SIRO Clinpharm.

 
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Medical Devices: MDD Recast

Mark of Approval

Erdmann J Zippel at D-TARGET (a Premier Research Company) provides an insight into how the amendment to the Medical Device Directive has changed the approval process and has had a positive effect on patient safety, citing examples from countries in the European Union.

 
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Medical Devices: US and Europe

Spot the Difference

Georg A Mathis, Annick Toggenburgerand Rolf Marugg at Appletree AG compare the regulatory differences between the US and Europe when it comes to the development of medical devices.


 
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Clinical Development

Immunometabolism

New Therapeutic Avenues

It has become increasingly clear that the accumulation of vast amounts of fat in adipose tissue is linked to significant alterations in the immune system. Our increased understanding of the relationship between the two will help in the treatment and prevention of obesity-related disorders, explains Joseph A Cornicelli atCharles River Discovery Services.

 
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Drug Development & Delivery
Drug Development: Bioavailability and Solubility

Parallel Screening

Improving solubility and bioavailability is a multifaceted challenge in the drug development process, with many technologies promising varying degrees of success. Kwok Chow and Anil Kane of Patheon Inc consider the use of a parallel screening approach to provide fast, cost-effective results.
 
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS

Medical Devices: Paediatrics

In Small Doses

Andre Muelenaer at Carilion Clinic Children’s Hospital and Alfred L Wicks at Virginia Tech University give an insight into the structure and activities of the Paediatric Trials Network and its strategic partnerships to promote the development of devices for children.

 
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Autoimmune Disorders: MENA Region

Unmet Needs

As autoimmune diseases become more widespread in the Middle East and North Africa, Rani Abraham at ClinTec stresses the need for more clinical trials to be performed locally, discussing those diseases with the highest incidence in the region.

 
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Medical Devices: Development

Ergonomically Sound

Michael P Craven and Jennifer L Martinof the Faculty of Engineering at the University of Nottingham, Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) discuss the crucial role of the end-user in the medical device product development pathway.

 
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CDISC & Electronic Data Capture

CDISC Update

Strength Through Collaboration

Lauren Shinaberry of PRA, and chair-elect of the CDISC Advisory Board for 2011, provides an insight into CDISC’s vision for the future and how the organisation intends to make full use of the opportunities new technology is offering.

 
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Data Management & IT Solutions

Early Clinical Drug Development

Flexible Study Designs

David Underwood at Quanticate provides an overview of the ways in which Phase 1 packages can be conducted more efficiently using combination, flexible protocols to speed up the time to becoming Phase 2 ready.

 
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Regional Focus

Global Clinical Trials: MENA Region

Shifting Sands

The Middle East and North Africa region is an exciting emerging market growth opportunity.Vladimir Misik of Quintiles presents an in-depth analysis of the region as a destination for R&D.

 
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Global Clinical Trials: Poland

Local Wisdom

There are many advantages to carrying out R&D in Poland. Basia Kondratowicz at Simbec Research Limited (an Altasciences Company) explores the increasing interest in the region as an emerging market in which to conduct clinical trials.


 
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Global Clinical Trials: Latin America

The Promise Land

Paul Braconnier, Laura Garcia and Patricia Goddard at Harrison Clinical Research Group delve into the benefits of conducting clinical trials in Latin America – looking particularly at Argentina and Mexico.

 
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Published quarterly in
February, May,
August and November

News and Press Releases

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
More info >>

White Papers

Advances in Aseptic Blow-Fill-Seal Processing of Pharmaceutical Liquids Improve Product Integrity and Patient Safety

Weiler Engineering, Inc

The latest improvements in aseptic blow-fill-seal technology are providing more streamlined automation of critical B/F/S processing areas, while limiting human intervention and effectively reducing airborne microbial bioburden and particulate levels, and enhancing sterility assurance and patient safety.
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Industry Events

3rd Annual Inhalation & Respiratory Drug Delivery Congress

8-9 May 2018, London, UK

Oxford Global are proud to present our hugely popular 3rd Annual Inhalation & Respiratory Drug Delivery Congress, 8th – 9th May 2018, London, UK. Over 300 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions will gather for over 20 presentations and case studies focused on the key issues in inhalation and respiratory drug delivery.
More info >>

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