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International Clinical Trials

ict
Winter 2016

   
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Editor's Comment

Graham Hughes welcomes the new year by highlighting a selection of articles from this edition, including regulatory updates, the increasing need for real world studies, and strategic partnerships.
 
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REGULATORY
Data Management

Done Deal


The much-anticipated General Data Protection Regulation is set to take effect in EU member states in 2018. Pete Chan at Tudor Reilly Health comments on some of the changes and voices concerns that these will not be sufficient enough.
 
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Regulatory Update

EU Clinical Trial Regulation: Be Prepared


Also introduced in 2018, the EU Clinical Trial Regulation will have sponsors preparing for this new legislative framework to maximise positive efficiencies and minimise burdens – according to NDA’s Olga Björklund and Dr Brian Edwards.
 
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Clinical Data

Trials and Tribulations

Sophie Pelé
at Dechert elaborates on the scientific and political benefits the publication of clinical trial patient data brings, and whether these can overcome legal risks.
 
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Clinical Trial Management
Real World Evidence

Chasing Reality


Jonathan Hart-Smith at CK Aspire talks about the growing demand for real world evidence studies in deciding on a clinical trial pathway, and discovers it supports the increasing needs of payers.
 
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Q&A: Oncology Research

Putting the Patient First


Inability to retain patients is the reason why almost half of oncology studies fail, CRF Health’s Jessica Thilaganathan tells ICT, and proposes electronic clinical outcome solutions as a remedy.
 
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Patient Recruitment

Take a Chance

Patient enrolment in clinical trials is taken to a new level by embracing a more digital approach, thus eliminating the need to rely on luck. Clare Jackson, Utku Ozdemir and Liz Moench at MediciGlobal outline the advantages this brings.
 
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Clinical Trial Supply & Packaging
Smart Thermal Packaging

Hot and Cold
 

Transporting temperature-sensitive drugs need not always be a challenge – using vacuum-insulated packaging and implementing selection criteria can enhance the cold chain, remarks Fabian Eschenbach at va-Q-tec.
 
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Q&A: Clinical Trial Logistics

Cold to the Touch

World Courier
’s Sue Lee reflects on the evolving developments and requirements in clinical trial logistics, and tells ICT about the move towards patient-centred processes and supplies.
 
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MARKETPLACE
Supply Efficiencies

The Power of Strategic Sourcing


Closer strategic partnerships between pharma companies, CROs and specialist comparator sourcing agencies are the result of increasing complexity and external drivers, states Clinigen Clinical Trial ServicesSteve Glass – thus bolstering efficiencies without compromising quality.
 
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2016 Predictions

All Things Digital


Abraham Gutman at AG Mednet predicts the upcoming technological advances of 2016, with a view towards moving closer to zero delays for clinical trials.
 
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End Point

Money Talks

Graham Hughes
examines the reasons for high drug prices – highlighting the differences among some countries – and what implications this has for the pharma industry.
 
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Central Labs
Biomarker Advances

Aim for the Top

Medpace
’s Paul Travis is convinced that biomarkers are the way forward for CROs wanting to keep up with the latest drug development trends and harness new technologies and regulations.
 
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Microbiological Labs

Driven by Results: Part 1


Quantitative urine culture studies can be challenging to conduct, particularly with microbiology labs under ever-increasing pressure to perform. Olga Sazonova, Veronika Khokhlova, Andrey Karelin and Maxim Belotserkovsky at PSI CRO present techniques for achieving optimal results in the first of a two-part article.
 
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Digital Advances
Q&A: Digital and Cloud Developments

A Step Ahead
 

Medidata’s Kara Dennis and Matt Noble discuss the latest digital advances – such as mHealth devices, patient-centric research, and innovative products like wearables, hearables and medical smart patches.
 
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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

Envigo rat models proven to be susceptible to intra-vaginal HSV-2 infection and protectable by attenuated HSV-1 against symptomatic HSV-2


More info >>

White Papers

New Temperature Profiles from a Global Study

Laminar Medica

Recently there has been an influx of temperature mapping studies to collect sufficient ambient data to develop temperature profiles.  Solid temperature profiles on specific shipping routes are required to ensure streamlined packaging and robust lane qualification. The most reliable method to develop temperature profiles is to capture the actual reading from shipments, as well as using the historical and meteorological data to increase the confidence level.
More info >>

Industry Events

Pharma Supply and Logistics Innovation Program

6-7 June 2016, Hamburg, Germany

Pharma Supply and Logistics innovation program is a unique platform for 80+ Pharma and Biotech Companies with the collaborations of supply and logistics service providers.
More info >>

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