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PUBLICATIONS

International Clinical Trials

ict
Spring 2014

   
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Editor’s Comment

Introducing this edition of ICT, Graham Hughes highlights articles on the new era of data transparency and work to tackle metabolic health conditions.
 
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Regulatory & Business Practice
Tax Relief

Inside the Box

UK life sciences companies are still to fully realise the benefi ts of the Patent Box, perhaps because this tax relief regime for patented products is still bedding in – but they should sign up now, advises Rhian Osborne at Greenaway Scott.


 
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TRIAL MANAGEMENT
Regulatory Submissions

In the Cloud

With global submissions becoming an ever-more complex process, Rik van Mol from Veeva Systems describes how pharma is turning to multitenant cloud-based platforms to speed up applications and keep companies in sync with worldwide health authorities.

 
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Site Payments

Automatic Drive


Beyond simply reimbursing investigator sites quickly, automated payment systems also offer other advantages to boost trial performance, particularly for complex, later-phase studies. Heather Schultz at Clinverse fills us in.

 
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Risk-Based Monitoring

Quality Control

It may have had limited application to date, but quality risk management can be used to enhance best practice across drug development. Nicole Stansbury and Stephannie Perrin of PPD explain how risk-based monitoring is taking advantage.
 
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eCLINICAL
E-Patient Engagement

Rare Insights

Information on the location and prevalence of people with rare diseases is often hard to come by, but e-patient data and online analytics can provide granular insights that enable more targeted trials. Pete Chan of Tudor Reilly Health reports.
 
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Regional trials
Emerging Markets

BRIC by Brick


Entering the BRIC markets often makes strategic sense but, recommends Debashis Ghosh of Tata Consultancy Services, it is essential to fully explore the drivers and constraints to decide which is best for your business.

 
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Inherited Disorders

Ironing Out Thalassemia

Transfusion-based treatments for the rare blood disorder, thalassemia, raise the risk of iron overload to patients – particularly the high number of sufferers in the Middle East and North Africa. Rani Abraham at ClinTec calls for fresh research impetus.

 
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Asia-Pacific Studies

Border Crossing


Many sponsors are cashing in on the population growth and healthcare infrastructure in the Asia-Pacific region for their clinical R&D but, emphasises PCI’s Rich Nelson, care is needed to navigate the unique country-specific differences that impact on logistics and supply.
 
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DRUG DISCOVERY & DELIVERY
Diabetes Research

Early Warning


The rising clinical failure rate for drugs targeting diabetes highlights the need for improved preclinical evaluation to better assess the molecular mechanisms of the disease and shape later Phase 2 studies. Jim Wang at Crown Bioscience offers a case study.
 
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data management & statistical analysis
Data Analytics

Prime Numbers


With the transparency debate prompting the industry to shine a self-appraising spotlight on itself, companies will learn how to better manage the vast – but currently disjointed – data reservoirs it has access to, says PRA’s Gareth Adams.
 
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Data Disclosure

Transparency Impact


Opening the door to greater trial transparency will help drive clinical R&D and build trust. But, as Mathias Poensgen, Jessica Schell and Simon Wilson at ArisGlobal explain, pharma must also be alert to the implications of too much patient-level data being disclosed.

 
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Central Labs
Metabolic Diseases

Meta Data


The risk factors that make up metabolic syndrome are now more clearly understood and relatively easy to detect thanks to today’s methodologies and instrumentation. Tatiana Souslova from ACM Global Central Laboratory explores further.

 
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Laboratory Data

Local News

Tomasz Anyszek
and Michal Dysko at Synevo Central Labs outline how demand for more sophisticated outsourcing in research is leading to locally-based central laboratory networks and decentralised services as a cost-effective way to overcome logistics hurdles.
 
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Business Practice
R&D Investment

Growth Fund


The lack of funding options has been stifling R&D and innovation in life sciences, but Mark Howard and Jodie Dennis from Charles Russell LLP raise hopes that a more healthy mix of alternative and traditional investment is returning to the marketplace.
 
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Cancer Therapeutics
Breast Cancer

Mind Altering


The much-awaited results of the MINDACT trial are coming soon. Fatima Cardoso at Champalimaud Cancer Center, Miguel Martin at Hospital General Universitario Gregorio Marañón, and Gustavo Werutsky at Hospital São Lucas consider what it could mean for genomic signatures and chemotherapy.
 
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Cancer Diagnostics

Blood Pressure


Amid fears from the WHO of a cancer ‘tidal wave’, increasing attention is being focused on developing non-invasive blood-based tests to aid early diagnosis and tackle the current shortfall in screening. Mark Eccleston at VolitionRx looks forward to their implementation.
 
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Patient Recruitment and Retention
Recruitment and Retention

Brave New World


The Medical Research Network’s Graham Wylie calls for a shake-up to boost patient involvement in trials – reducing principal investigators and ineffective sites in favour of a more communityfocused system.
 
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Interview
Business Insight

Community Care


Exostar’s Richard Addi tells ICT about the information access and security issues as more companies come to rely on cloud-based communities.
 
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Industry Interview

Thinking Allowed


Complex medical device trials and operating in the current CRO landscape are among the talking points for John Potthoff of Theorem.
 
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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

Aesica Led Consortium Wins Technology Strategy Board Grant for Sustainable High-Value Chemical Manufacturing Through Industrial Biotechnology

Aesica, the global pharmaceutical contract development and manufacturing organisation (CDMO), has led a consortium, also comprising Charnwood Technical Consulting, CatScI and Biocatalysts, which has successfully won a Technology Strategy Board grant directed at funding sustainable, high value chemical manufacturing achieved through industrial biotechnology.
More info >>

White Papers

The Process of Informed Consent (written by ACRP)

CenterWatch

Every investigator and clinical research coordinator (CRC) should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. The purpose of this ACRP guidance document is not to provide a literature review or summarize the recommendations of various working groups. Instead, the Association decided it would be helpful to provide short and focused guidance which describes how to best structure the informed consent process in accordance with best practices.
More info >>

Industry Events

5th Annual Outsourcing in Clinical Trials East Coast

13-14 May 2014,

This coming May sees the welcome return of the 5th Annual Outsourcing in Clinical Trials East Coast Conference, in Philadelphia, PA, USA.
More info >>

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