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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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
More info >>

White Papers

Keeping Abreast of the Competitive Environment in Clinical Development

Thomson Reuters

Strategic management of a therapy area requires hard decisions to be made about which programs to invest in and which to let go. Understanding the rapidly changing competitive environment for your drug candidates is a key input into these decisions. It is easy to lose track of the broader picture when a clinical program is in progress and get blindsided by external events.
More info >>

Industry Events

Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
More info >>

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