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PUBLICATIONS

International Clinical Trials

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Winter 2013

   
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REGULATORY
Post-Approval Regulation

Priority PASS

Current and planned post-authorisation safety studies across Europe must now take into account revised pharmacovigilance rules, particularly for non-interventional studies. Miranda Dollen at Optum gives the latest.
 
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Trial Regulation

Euro Vision


Europeís clinical trial regulatory regime faces a shake-up in 2016 in a bid to streamline trial management and cut red tape. Janet Knowles and Carl Fennessy at Eversheds LLP look at the changes on the way.
 
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Clinical Trial Management
Site Payments

Donít Take it for Granted

If not done in a standardised manner, processing investigator grant payments can lead to regulatory non-compliance and commercial loss. A globally harmonised approach could make the difference, argues Kevin Williams at CFS Clinical.
 
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Data Management

The Big Picture

Discussing the technological advancements available for investigator sites to assemble and submit data, Abraham Gutman at AG Mednet underlines the importance of proper tools and a validated delivery platform for image-related trials.
 
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Budget Management

Cost Recovery

Kevin Nichols at Isis Pharmaceuticals emphasises the need for an integrated relationship between sponsors and EDC providers to reduce the cost of inevitable changes during trials and speed up product delivery to patients.
 
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CNS Disorders

Central Learning

With CNS disorders posing daunting challenges for 21st century healthcare, Mark Shapiro at Clinipace Worldwide predicts a new research landscape where advances in science, better operational technology and more collaborations bridge the wide gaps in CNS innovation.
 
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Event Review: Partnerships in Clinical Trials Congress

Market Analysis

Current market conditions and strategic alliances were top of the agenda at the recent Partnerships in Clinical Trials Congress. Graham Hughes was there.
 
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Digital Applications

Cyber Security

Mollie Shields-Uehling at SAFE-BioPharma Association discusses a digital identity and digital signature standard for secure authentication and the protection of electronic documents, along with its use in cloud collaboration, collecting hospital patient data and signing off ePrescriptions.

 
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Trial Infrastructure

Get Connected

The costs of investing in internet connectivity and computers for investigator sites are far outweighed by the savings that can be generated in terms of lower cost, reduced timelines and shorter time-to-market, says Martin Stricker at SIRO Clinpharm.
 
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Neurodegenerative Diseases

On Target

MitoTarget, a three-year collaborative proof-of-concept project, is exploring whether mitochondrial dysfunction could be addressed in a trial involving patients with ALS. Rebecca Pruss, Thierry Bordet, Julien Veys and Jean-Louis Abitbol at Trophos report.
 
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Discovery Technology

A New Engine

The future model of drug development needs to embrace a cost- and risk-sharing approach with increased outsourcing. Kevin Lustig and Maria Thompson at Assay Depot debate how a web-based platform for research exchanges is a key step to achieving this.
 
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Clinical Trial Supply & Packaging
Clinical Ancillaries

The Forgotten Challenge

Transporting clinical ancillaries may seem a minor, albeit crucial, add-on to wider clinical trial logistics, but it is often not given enough consideration. Alex Klim at DHL considers how the supply chain practicalities are getting ever-more complex.
 
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Regional trials
Translation

Language Barriers?

A multitude of local languages means that there is growing demand for translation services in Africa.But, as Simon Andriesen at MediLingua explains, the lack of suitably trained staff and professional standards are hurdles to overcome.

 
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Focus on MENA

On the Map

The Middle East and North Africa region is projected to be one of the fastest growing markets for clinical research, given its large treatment-naÔve population, and the timeline and cost advantages, says Nadia Cheaib at ClinServ.
 
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Regional Development

MENA Reality

Chiheb Guerfel at Poseidon Pharma Services assesses the emerging market potential of the Middle East and North Africa region for clinical trial activities, with its base of qualified graduates and good infrastructure an increasingly attractive prospect.

 
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Interview
Business Insight

Better Together


Craig Lipset of Pfizer is encouraged by the pharma industryís spirit of collaboration as it looks to accelerate smarter drug development.
 
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Industry Interview

Thinking Allowed

Rahlyn Gossen of Rebar Interactive talks to ICT about her career path, creative solutions and what the coming year has in store.

 
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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

IONTAS to Generate Antibodies using Mammalian Display Technology for a Global Biopharma

Cambridge, UK, 22 January 2018: IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, announced today that it has signed an agreement with Sanofi to discover antibodies using IONTASí proprietary Mammalian Display Technology.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

Industry Events

LogiPharma Europe 2018

10-12 April 2018, Montreux Music & Convention Centre

Now in itís 18th successful year, LogiPharma is the largest global end-to-end supply chain event for pharma supply chain leaders, their teams and service partners.
More info >>

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