International Clinical Trials |
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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
Europe’s 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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Site Payments
Don’t 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 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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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-naïve 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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Business Insight
Better Together
Craig Lipset of Pfizer is encouraged by the pharma industry’s 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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